Priority New Monograph Items
Drug Substances and Drug Products
The following list contains monographs USP is seeking for drug substances and drug products for which we estimate generic market entry within 5 years. These are articles that have been approved by the FDA and are published in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
Pending Monograph Submissions
Monographs that have been “Received as Pending” and “Posted as Pending” are marked as such. Monographs marked as “Received as Pending” are in development and have not yet advanced to having a draft posted on the USP Pending website. Monographs labeled as “Posted as Pending” are posted on the USP Pending Webpage and a link to that page is provided for each entry.
This list has been updated as of May 6, 2013.
Monograph sponsors should consult USP's Guideline for Submitting Requests for Revision to the USP–NF.
For additional information, or for comments about the list, contact Randy Kiser, M.S., M.B.A., rwk@usp.org.
Small Molecules Actives (Drug Substances) | Small Molecules Actives (Drug Products) | Inactive Ingredients
MONOGRAPH NAME | ||
| Small Molecule Drug Substances as of May 6, 2013 | ||
| Abiraterone Acetate Received as Pending | Acamprosate Calcium Posted as Pending | Aclidinium Bromide |
| Acrivastine | Alcaftadine | Alitretinoin |
| Allopurinol Sodium | Alosetron Hydrochloride | Alvimopan |
| Ambenonium Chloride | Aminolevulinic Acid Hydrochloride | Amlexanox |
| Amphetamine Aspartate | Armodafinil Received as Pending | Arsenic Trioxide |
| Auranofin | Azacitidine Posted as Pending | Azelaic Acid Received as Pending |
| Bendamustine Hydrochloride | Bentoquatam | Bepotastine Besylate |
| Beractant | Besifloxacin Hydrochloride | Bexarotene |
| Bismuth Subcitrate Potassium | Bortezomib | Bosentan Posted as Pending |
| Brimonidine Tartrate Received as Pending | Bromfenac Sodium Received as Pending | Buprenorphine |
| Butenafine Hydrochloride | Butylscopalamine Bromide | Caffeine Citrate |
| Calfactant | Caspofungin Acetate | Cefditoren Pivoxil Posted as Pending |
| Ceftibuten | Cevimeline Hydrochloride | Chlorpheniramine Polistirex |
| Ciclesonide | Cidofovir | Cinacalcet Hydrochloride |
| Clobazam | Colesevelam Hydrochloride Posted as Pending | Cysteamine Bitartrate |
| Dalfampridine Posted as Pending | Dalfopristin | Darifenacin Hydrobromide Received as Pending |
| Decitabine - Decitabine | Deferiprone | Delavirdine Mesylate |
| Desirudin | Dexmethylphenidate Hydrochloride | Dexrazoxane |
| Dextroamphetamine Saccharate | Diclofenac Epolamine Received as Pending | Difenoxin Hydrochloride |
| Difloxacin Hydrochloride | Difluprednate | Doripenem |
| Eflornithine Hydrochloride | Eletriptan Hydrobromide | Enfuvirtide |
| Eplerenone | Ertapenem Sodium | Estradiol Acetate |
| Estramustine Phosphate Sodium | Eszopiclone Posted as Pending | Ethanolamine Oleate |
| Etonogestrel Posted as Pending | Etoposide Phosphate | Exemestane Posted as Pending |
| Ezogabine | Fenofibric Acid | Ferric Hexacyanoferrate (Prussian Blue) |
| Ferric Sodium Gluconate | Fingolimod | Fomepizole |
| Frovatriptan Succinate Received as Pending | Gadobenate Dimeglumine | Gadobutrol |
| Gadofosveset Trisodium | Gadopentetic Acid | Gadoxetate Disodium |
| Gallium Nitrate | Ganciclovir Sodium | Ganirelix Acetate |
| Gatifloxacin Posted as Pending | Hetastarch | Hydrocodone Polistirex |
| Hydrocortisone Probutate | Iloperidone | Iloprost |
| Imidacloprid | Isocarboxazid | Isosulfan Blue |
| Ketotifen Fumarate | Lacosamide Received as Pending | Lactulose |
| Lanthanum Carbonate | Lepirudin | Linezolid Posted as Pending |
| Lodoxamide Tromethamine | Loteprednol Etabonate | Lurasidone Hydrochloride |
| Melphalan Hydrochloride | Mepenzolate Bromide | Methyl Aminolevulinate Hydrochloride |
| Metipranolol Hydrochloride | Midazolam Hydrochloride | Mifepristone Posted as Pending |
| Milrinone Lactate | Nabilone | Nalbuphine Hydrochloride |
| Nebivolol Hydrochloride Received as Pending | Nedocromil Sodium | Nelarabine |
| Nelfinavir Mesylate Received as Pending | Nepafenac | Nesiritide Citrate |
| Nilutamide | Nisoldipine Received as Pending | Nitazoxanide Posted as Pending |
| Nitisinone | Norflurane | Olsalazine Sodium |
| Oxiconazole Nitrate Received as Pending | Oxytetracycline Hydrochloride Boluses | Paliperidone Palmitate |
| Pemetrexed Disodium | Pemirolast Potassium | Penciclovir |
| Pentostatin | Pimecrolimus | Piperonyl Butoxide |
| Pirbuterol Acetate | Pitavastatin | Plerixafor |
| Podofilox | Poractant Alfa | Porfimer Sodium |
| Pralatrexate | Quinupristin | Regorafenib |
| Remifentanil Hydrochloride | Rifapentine | Roflumilast |
| Romifidine Hydrochloride | Sapropterin Dihydrochloride | Sertaconazole Nitrate |
| Sincalide | Sirolimus Received as Pending | Sodium Oxybate |
| Sodium Picosulfate Posted as Pending | Spinosad | Streptozocin |
| Succimer | Tafluprost | Tazarotene |
| Telithromycin | Temsirolimus | Tenofovir Disoproxil Fumarate Posted as Pending |
| Teriflunomide | Tetrabenazine | Thymol Iodide |
| Tiludronate Disodium | Tiopronin | Tirofiban |
| Tolvaptan | Toremifene Citrate | Treprostinil |
| Trypan Blue | Ulipristal Acetate Received as Pending | Vardenafil Hydrochloride |
Small Molecules Actives (Drug Substances) | Small Molecules Actives (Drug Products) | Inactive Ingredients
MONOGRAPH NAME | ||
| Small Molecule Drug Products as of May 6, 2013 | ||
| Abiraterone Acetate Tablets | Acamprosate Delayed-Release Tablets | Acetaminophen Injection |
| Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Capsules | Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets | Acetazolamide Extended-Release Capsules |
| Acetic Acid and Aluminum Acetate Otic Solution | Acetylcysteine Inhalation Solution | Aclidinium Bromide Inhalation Powder |
| Acrivastine and Pseudoephedrine Hydrochloride Capsules | Acyclovir Cream | Adapalene Cream |
| Adapalene and Benzoyl Peroxide Gel | Adapalene Gel | Albuterol for Inhalation |
| Albuterol Inhalation Aerosol | Albuterol Oral Solution | Alcaftadine Ophthalmic Solution |
| Alendronate Sodium and Cholecalciferol Tablets | Alendronate Sodium Oral Solution | Alitretinoin Topical Gel |
| Allopurinol for Injection | Alosetron Tablets | Alprostadil for Injection |
| Alprostadil Urethral Suppository | Alumina and Magnesium Trisilicate Chewable Tablets | Alvimopan Capsules |
| Amantadine Hydrochloride Tablets | Ambenonium Chloride Tablets | Amcinonide Lotion |
| Aminolevulinic Acid Topical Solution | Amlexanox Oral Paste | Amlodipine and Atorvastatin Tablets |
| Amlodipine and Olmesartan Medoxomil Tablets | Amlodipine, Olmesartan Medoxomil and Hydrochlorothiazide Tablets | Amphetamine Aspartate, Amphetamine Sulfate, Dextroamphetamine Saccharate and Dextroamphetamine Sulfate Tablets |
| Amphetamine Mixed Salts Extended-Release Capsules | Amphotericin B Injection | Amphotericin B Liposome for Injection |
| Apomorphine Hydrochloride Injection | Argatroban In Dextrose Injection | Argatroban In Sodium Chloride Injection |
| Argatroban Injection | Aripiprazole Tablets | Armodafinil Tablets |
| Arsenic Trioxide Injection | Aspirin and Dipyridamole Extended-Release Capsules | Atropine and Pralidoxime Chloride Injection |
| Auranofin Capsules | Avobenzone, Octinoxate, and Oxybenzone Lotion | Azacitidine for Injectable Suspension |
| Azelaic Acid Cream | Azelaic Acid Topical Gel | Azelastine Hydrochloride Nasal Spray |
| Azelastine Hydrochoride and Fluticasone Propionate Nasal Spray | Azithromycin Ophthalmic Solution | Aztreonam for Inhalation Solution |
| Baclofen Injection | Balsalazide Disodium Tablets | Beclomethasone Dipropionate Inhalation Aerosol |
| Beclomethasone Dipropionate Metered-Dose Nasal Suspension | Benazepril Hydrochloride and Hydrochlorothiazide Tablets | Bendamustine Hydrochloride for Injection |
| Bentoquatam Topical Suspension | Benzyl Alcohol Lotion | Bepotastine Besylate Ophthalmic Solution |
| Beractant Intratracheal Suspension | Besifloxacin Ophthalmic Suspension | Betaine for Oral Solution |
| Betamethasone Dipropionate and Calcipotriene Ointment | Betamethasone Dipropionate and Calcipotriene Topical Suspension | Betamethasone Dipropionate Topical Gel |
| Betamethasone Valerate Topical Foam | Betaxolol Ophthalmic Suspension | Bexarotene Capsules |
| Bexarotene Topical Gel | Bisacodyl Tablets | Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Capsules |
| Bortezomib for Injection | Bosentan Tablets | Brimonidine Tartrate Ophthalmic Solution |
| Bromfenac Sodium Ophthalmic Solution | Brompheniramine Maleate, Dextromethorphan Hydrobromide and Pseudoephedrine Hcl Oral Solution | Budesonide and formoterol Fumarate Inhalation Aerosol |
| Budesonide Inhalation Powder | Budesonide Inhalation Suspension | Budesonide Nasal Spray |
| Buprenorphine and Naloxone Sublingual Film | Buprenorphine and Naloxone Sublingual Tablets | Buprenorphine Hydrochloride Injection |
| Buprenorphine Sublingual Tablets | Buprenorphine Transdermal System | Busulfan Injection |
| Butalbital and Acetaminophen Capsules | Butalbital and Acetaminophen Tablets | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules |
| Butenafine Hydrochloride Cream | Calcipotriene Cream | Calcipotriene Foam |
| Calcipotriene Topical Solution | Calcitriol Capsules | Calcitriol Ointment |
| Calcitriol Oral Solution | Calcium Acetate Capsules | Calcium Acetate Oral Solution |
| Calfactant Intratracheal Suspension | Candesartan Cilexetil and Hydrochlorothiazide Tablets Received as Pending | Capsaicin Topical Patch |
| Carbamazepine Extended-Release Capsules | Carbidopa Tablets | Carbidopa, Levodopa, and Entacapone Tablets |
| Carbinoxamine Maleate Oral Solution | Carboplatin Injection | Carglumic Acid Tablets for Oral Suspension |
| Carmustine Implant | Caspofungin Acetate for Injection | Cefditoren Pivoxil Tablets |
| Cefepime Injection | Cefixime Capsules | Cefotaxime In Dextrose Injection |
| Ceftibuten Capsules | Ceftibuten for Oral Suspension | Celecoxib Capsules |
| Cetirizine Hydrochloride Capsules | Cetirizine Hydrochloride Chewable Tablets | Cetirizine Hydrochloride Orally Disintegrating Tablets |
| Cevimeline Hydrochloride Capsules | Chlorpheniramine Maleate Extended-Release Tablets | Choline C 11 Injection |
| Ciclesonide Inhalation Aerosol | Ciclesonide Nasal Aerosol | Ciclesonide Nasal Spray |
| Ciclopirox Shampoo | Ciclopirox Topical Gel | Cidofovir Injection |
| Cimetidine Oral Solution | Cinacalcet Tablets | Ciprofloxacin Hydrochloride and Hydrocortisone Otic Suspension |
| Ciprofloxacin Oral Suspension | Ciprofloxacin Otic Solution | Cisplatin Injection |
| Citalopram Capsules | Citric Acid, Gluconolactone, and Magnesium Carbonate Irrigation | Clemastine Fumarate, Acetaminophen and Pseudoephedrine Hydrochloride Tablets |
| Clemastine Oral Solution | Clenbuterol Hydrochloride Oral Solution | Clindamycin and Benzoyl Peroxide Topical Gel |
| Clindamycin Phosphate and Tretinoin Gel | Clindamycin Phosphate Injection | Clobazam Tablets |
| Clobetasol Propionate Foam | Clobetasol Propionate Gel | Clobetasol Propionate Lotion |
| Clobetasol Propionate Spray | Clofarabine Injection | Clonidine Extended-Release Tablets |
| Clotrimazole and Betamethasone Dipropionate Lotion | Clozapine Orally-Disintegrating Tablets | Colesevelam Hydrochloride for Oral Suspension |
| Colesevelam Hydrochloride Tablets | Conjugated Estrogens and Medroxyprogesterone Acetate Tablets | Conjugated Estrogens for Injection |
| Conjugated Estrogens Vaginal Cream | Copper Wire Intrauterine Device | Cromolyn Sodium Oral Solution |
| Crotamiton Lotion | Cyanocobalamin Nasal Spray | Cyclopentolate and Phenylephrine Hydrochlorides Ophthalmic Solution |
| Cyclosporine Ophthalmic Emulsion | Cysteamine Bitartrate Capsules | Cytarabine Injection |
| Cytarabine Liposome Injection | Dalfampridine Extended-Release Tablets | Dapsone Gel |
| Darifenacin Extended-Release Tablets | Daunorubicin Hydrochloride Injection | Decitabine for Injection |
| Deferiprone Tablets | Delavirdine Mesylate Tablets | Desirudin for Injection |
| Desloratadine and Pseudoephedrine Sulfate Extended- Release Tablets | Desloratadine Oral Solution | Desonide Cream |
| Desonide Lotion | Desonide Ointment | Dexmethylphenidate Hydrochloride Extended-Release Capsules |
| Dexmethylphenidate Hydrochloride Tablets | Dextroamphetamine Sulfate Extended-Release Capsules | Dextromethorphan Polistirex Extended-Release Oral Suspension |
| Diatrizoate Sodium for Oral Solution | Diatrizoic Acid and Iodipamide Injection | Diazepam Oral Solution |
| Diazepam Rectal Gel | Diclofenac Epolamine Topical Patch | Diclofenac Sodium Cream |
| Diclofenac Sodium Ophthalmic Solution | Diclofenac Sodium Topical Gel | Diclofenac Sodium Topical Solution |
| Dienogest and Estradiol Valerate Tablets | Diethylpropion Hydrochloride Extended-Release Tablets | Difenoxin and Atropine Tablets |
| Difloxacin Hydrochloride Tablets | Difluprednate Ophthalmic Emulsion | Dihydroergotamine Mesylate Nasal Solution |
| Diltiazem for Injection | Diltiazem Hydrochloride Extended-Release Tablets | Diltiazem Hydrochloride Injection |
| Dimethyl Sulfoxide Intravesical Solution | Dinoprostone Vaginal Suppositories | Diphenhydramine Hydrochloride and Acetaminophen Tablets |
| Diphenhydramine Hydrochloride Tablets | Docetaxel for Injection | Docosanol Cream |
| Dofetilide Capsules | Doripenem for Injection | Doxazosin Extended-Release Tablets |
| Doxepin Hydrochloride Cream | Doxepin Tablets | Doxorubicin Hydrochloride Pegylated Liposome Injection |
| Doxycycline Hyclate for Injection | Doxycycline Hyclate Periodontal System | Doxycycline Oral Gel |
| Drospirenone and Estradiol Tablets | Dutasteride and Tamsulosin Hydrochloride Capsules | Dutasteride Capsules |
| Econazole Nitrate Cream | Edrophonium Chloride and Atropine Sulfate Injection | Eflornithine Hydrochloride Cream |
| Eletriptan Tablets | Enfuvirtide for Injection | Enrofloxacin and Silver Sulfadiazine Otic Emulsion |
| Entecavir Oral Solution | Epinastine Hydrochloride Ophthalmic Solution | Epirubicin Hydrochloride for Injection |
| Eplerenone Tablets | Eprosartan Mesylate and Hydrochlorothiazide Tablets | Eprosartan Tablets |
| Eptifibatide Injection | Ertapenem for Injection | Esmolol Hydrochloride Injection |
| Esomeprazole Sodium for Injection | Estradiol Acetate Tablets | Estradiol Acetate Vaginal System |
| Estradiol and Levonorgestrel Transdermal System | Estradiol and Norethindrone Acetate Transdermal System | Estradiol and Norgestimate Tablets |
| Estradiol Gel | Estradiol Transdermal Spray | Estramustine Phosphate Sodium Capsules |
| Eszopiclone Tablets | Ethanolamine Oleate Injection | Etodolac Injection |
| Etonogestrel and Ethinyl Estradiol Vaginal System | Etonogestrel Implant | Etoposide Phosphate for Injection |
| Exemestane Tablets | Ezetimibe and Simvastatin Tablets | Ezetimibe Tablets Received as Pending |
| Ezogabine Tablets | Famotidine, Calcium Carbonate, and Magnesium Hydroxide Tablets | Fenofibric Acid Tablets |
| Fentanyl Buccal Film | Fentanyl Buccal Tablets | Fentanyl Lozenges |
| Fentanyl Nasal Spray | Fentanyl Sublingual Spray | Fentanyl Sublingual Tablets |
| Ferric Sodium Gluconate Injection | Fexofenadine Hydrochloride Orally Disintegrating Tablets | Fingolimod Capsules |
| Flunisolide Inhalation Aerosol | Flunisolide Nasal Spray | Fluocinolone Acetonide Intravitreal Implant |
| Fluocinolone Acetonide Otic Oil Solution | Fluocinolone Acetonide Shampoo | Fluocinolone Acetonide, Hydroquinone and Tretinoin Cream |
| Fluorescein Sodium Injection | Fluorometholone Ointment | Fluvoxamine Maleate Extended-Release Capsules |
| Fomepizole Injection | Formoterol Fumarate Inhalation Powder | formoterol Fumarate Inhalation Solution |
| Foscarnet Sodium Injection | Fosfomycin for Oral Solution | Frovatriptan Succinate Tablets |
| Fulvestrant Injection | Gabapentin Oral Solution | Gadobenate Dimeglumine Injection |
| Gadobutrol Injection | Gadofosveset Trisodium Injection | Gadoxetate Disodium Injection |
| Galantamine Oral Solution | Gallium Nitrate Injection | Ganciclovir Intravitreal Implant |
| Ganciclovir Ophthalmic Gel | Ganirelix Acetate Injection | Gatifloxacin Ophthalmic Solution |
| Gemcitabine Injection | Gentamicin In Sodium Chloride Injection | Gentamicin Sulfate Injection |
| Glipizide Extended-Release Tablets | Glycopyrrolate Oral Solution | Granisetron Hydrochloride Oral Solution |
| Granisetron Transdermal System | Guaifenesin and Dextromethorphan Hydrobromide Extended-Release Tablets | Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets |
| Guaifenesin Extended-Release Tablets | Guanfacine Extended-Release Tablets | Guanidine Hydrochloride Tablets |
| Halobetasol Propionate Cream | Halobetasol Propionate Ointment | Haloperidol Decanoate Injection |
| Hetastarch In Sodium Chloride Injection | Hydralazine Hydrochloride and Hydrochlorothiazide Capsules | Hydralazine Hydrochloride and Isosorbide Dinitrate Tablets |
| Hydrocodone Bitartrate and Acetaminophen Capsules | Hydrocodone Bitartrate and Acetaminophen Oral Solution | Hydrocodone Bitartrate and Homatropine Methylbromide Syrup |
| Hydrocodone Bitartrate and Ibuprofen Tablets | Hydrocodone Bitartrate and Pseudophedrine Hydrochloride Oral Solution | Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride Oral Solution |
| Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Capsules | Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension | Hydrocortisone Acetate and Pramoxine Hydrochloride Cream |
| Hydrocortisone Acetate and Pramoxine Hydrochloride Lotion | Hydrocortisone Acetate and Pramoxine Hydrochloride Topical Aerosol | Hydrocortisone Acetate and Urea Cream |
| Hydrocortisone Butyrate Lotion | Hydrocortisone Butyrate Ointment | Hydrocortisone Probutate Cream |
| Hydromorphone Hydrochloride Extended-Release Tablets | Ibandronate Sodium Injection | Ibuprofen and Famotidine Tablets |
| Ibuprofen and Pseudoephedrine Hydrochloride Capsules | Ibuprofen and Pseudoephedrine Hydrochloride Suspension | Ibuprofen Capsules |
| Ibuprofen Chewable Tablets | Ibutilide Fumarate Injection | Iloperidone Tablets |
| Iloprost Inhalation Solution | Iobenguane I 124 Injection | Iodine I 131 Tositumomab Injection |
| Ioflupane I 123 Injection | Iohexol Solution | Ipratropium Bromide and Albuterol Inhalation Spray |
| Ipratropium Bromide and Albuterol Sulfate Inhalation Aerosol | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution | Ipratropium Bromide Inhalation Aerosol |
| Ipratropium Bromide Inhalation Solution | Isosulfan Blue Injection | Isradipine Extended-Release Tablets |
| Itraconazole Tablets | Itraconazole Capsules | Itraconazole Oral Solution |
| Ketoconazole Cream | Ketoconazole Foam | Ketoconazole Gel |
| Ketoconazole Shampoo | Ketorolac Tromethamine Nasal Spray | Ketorolac Tromethamine Ophthalmic Solution |
| Ketotifen Fumarate Ophthalmic Solution | Lacosamide Injection | Lacosamide Oral Solution |
| Lacosamide Tablets | Lactated Ringers Solution | Lactulose for Oral Solution |
| Lanthanum Carbonate Chewable Tablets | Latanoprost Ophthalmic Solution Posted as Pending | Lepirudin for Injection |
| Leucovorin Calcium for Injection | Levetiracetam Injection | Levocetirizine Dihydrochloride Oral Solution |
| Levofloxacin Ophthalmic Solution | Levonorgestrel Intrauterine System | Levonorgestrel Tablets |
| Levothyroxine Sodium Capsules | Levothyroxine Sodium for Injection | Lidocaine and Prilocaine Periodontal Gel |
| Lidocaine and Tetracaine Cream | Lidocaine and Tetracaine Topical Patch | Lidocaine Hydrochloride Ophthalmic Gel |
| Lidocaine Transdermal System | Linezolid Injection | Linezolid Tablets Posted as Pending |
| Liothyronine Injection | Lodoxamide Ophthalmic Solution | Loperamide Hydrochloride and Simethicone Chewable Tablets |
| Loperamide Hydrochloride and Simethicone Tablets | Loperamide Hydrochloride Oral Suspension | Lopinavir and Ritonavir Capsules |
| Loratadine Capsules | Loratadine Oral Suspension | Loteprednol Etabonate and Tobramycin Ophthalmic Suspension |
| Loteprednol Etabonate Ophthalmic Gel | Loteprednol Etabonate Ophthalmic Ointment | Loteprednol Etabonate Ophthalmic Suspension |
| Lovastatin Extended-Release Tablets | Lurasidone Hydrochloride Tablets | Magnesium Chloride, Sodium Bicarbonate, and Sodium Chloride Injection |
| Mannitol and Sorbitol Irrigation Solution | Mannitol Irrigation | Melphalan for Injection |
| Memantine Hydrochloride Extended Release Capsules | Memantine Hydrochloride Oral Solution | Menthol and Methyl Salicylate Transdermal System |
| Mepenzolate Bromide Tablets | Mesalamine Delayed-Release Capsules | Mesalamine Suppositories |
| Mesna Injection | Mesna Tablets | Metformin Hydrochloride Oral Solution |
| Methacholine Chloride for Inhalation Solution | Methocarbamol and Aspirin Tablets | Methoxsalen Injection |
| Methyl Aminolevulinate Cream | Methylnaltrexone Bromide Injection | Methylphenidate Hydrochloride Chewable Tablets |
| Methylphenidate Hydrochloride Extended-Release Capsules | Methylphenidate Hydrochloride for Extended Release Oral Suspension | Methylphenidate Hydrochloride Oral Solution |
| Methylphenidate Transdermal System | Metipranolol Ophthalmic Solution | Metoclopramide Hydrochloride Orally Disintegrating Tablets |
| Metronidazole Cream | Metronidazole Extended-Release Tablets | Metronidazole Lotion |
| Metyrapone Capsules | Miconazole Buccal Tablets | Miconazole Nitrate Ointment |
| Midazolam Oral Suspension | Mifepristone Tablets | Milrinone Injection |
| Mometasone Furoate and formoterol Fumarate Inhalation Aerosol | Mometasone Furoate Inhalation Powder | Mometasone Furoate Nasal Spray |
| Morphine Sulfate and Naltrexone Hydrochloride Extended-Release Capsules | Morphine Sulfate Oral Solution | Morphine Sulfate Tablets |
| Moxifloxacin In Sodium Chloride Injection | Moxifloxacin Tablets Received as Pending | Multiple Electrolytes and Amino Acids Injection |
| Multiple Electrolytes Solution | Mycophenolate Mofetil Oral Solution | Mycophenolic Acid Delayed-Release Tablets |
| Nabilone Capsules | Nafcillin Sodium Injection | Nalbuphine Hydrochloride Injection |
| Naltrexone for Extended-Release Injectable Suspension | Naproxen Extended-Release Tablets | Naproxen Sodium Capsules |
| Nebivolol Tablets Received as Pending | Nedocromil Sodium Ophthalmic Solution | Nelarabine Injection |
| Nelfinavir Oral Powder Received as Pending | Nelfinavir Tablets Received as Pending | Neomycin Sulfate Oral Powder |
| Nepafenac Ophthalmic Suspension | Nesiritide for Injection | Nevirapine Extended Release Tablets |
| Niacin and Lovastatin Extended-Release Tablets | Niacin and Simvastatin Extended-Release Tablets | Nicardipine Hydrochloride Capsules |
| Nicardipine Hydrochloride Extended-Release Capsules | Nicotine Inhaler | Nicotine Metered-Dose Nasal Inhaler |
| Nicotine Polacrilex Lozenge | Nilutamide Tablets | Nimodipine Capsules |
| Nisoldipine Extended-Release Tablets | Nitazoxanide for Oral Suspension | Nitazoxanide Tablets |
| Nitisinone Capsules | Nitroglycerin Aerosol | Nitroglycerin Lingual Spray |
| Nitroglycerin Transdermal System | Nizatidine Oral Solution | Norelgestromin and Ethinyl Estradiol Transdermal System |
| Norethindrone and Ethinyl Estradiol Chewable Tablets | Ofloxacin Otic Solution | Olanzapine for Injection |
| Olmesartan Medoxomil and Hydrochlorothiazide Tablets | Olmesartan Medoxomil Tablets | Olopatadine Hydrochloride Nasal Spray |
| Olsalazine Sodium Capsules | Omeprazole and Sodium Bicarbonate Capsules | Omeprazole Delayed-Release Tablets |
| Omeprazole Magnesium for Delayed-Release Oral Suspension | Ondansetron Oral Film | Oseltamivir Phosphate for Oral Suspension |
| Oxacillin Sodium Injection | Oxiconazole Cream | Oxiconazole Nitrate Lotion |
| Oxycodone and Acetaminophen Oral Solution | Oxycodone Hydrochloride and Ibuprofen Tablets | Oxycodone Hydrochloride Capsules |
| Paclitaxel for Suspension | Paliperidone Extended-Release Tablets | Paliperidone Palmitate Extended-Release Injectable Suspension |
| Pamidronate Disodium Injection | Pantoprazole Sodium for Delayed-Release Oral Suspension | Pantoprazole Sodium for Injection |
| Paricalcitol Capsules | Paroxetine Oral Suspension | Peg 3350 for Oral Solution |
| Pemetrexed for Injection | Pemirolast Potassium Ophthalmic Solution | Penciclovir Cream |
| Pentamidine Isethionate for Inhalation | Pentamidine Isethionate for Injection | Pentostatin for Injection |
| Phendimetrazine Tartrate Extended-Release Capsules | Phentermine and Topiramate Extended-Release Capsules | Phentermine Hydrochloride Orally Disintegrating Tablets |
| Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup | Phenylephrine Hydrochloride, Chlorpheniramine Maleate, and Ibuprofen Tablets | Pilocarpine Hydrochloride Ophthalmic Gel |
| Pimecrolimus Cream | Pioglitazone and Metformin Hydrochlorides Extended-Release Tablets | Piperacillin and Tazobactam Injection |
| Piperonyl Butoxide and Pyrethrins Aerosol Foam | Pirbuterol Acetate Inhalation Aerosol | Pitavastatin Tablets |
| Plerixafor Injection | Podofilox Gel | Podofilox Topical Solution |
| Poractant Alfa Suspension | Porfimer Sodium for Injection | Povidone-Iodine Ophthalmic Solution |
| Pralatrexate Injection | Pramipexole Dihydrochloride Extended-Release Tablets | Prednisolone Acetate Oral Suspension |
| Prednisolone Sodium Phosphate Oral Solution | Prednisolone Sodium Phosphate Orally Disintegrating Tablets | Prednisone Delayed-Release Tablets |
| Progesterone Vaginal Gel | Pseudoephedrine Hydrochloride, Chlorpheniramine Maleate, and Codeine Phosphate Oral Solution | Pseudoephedrine Hydrochloride, Chlorpheniramine Maleate, and Ibuprofen Tablets |
| Pseudoephedrine Sulfate and Dexbrompheniramine Maleate Oral Solution | Pyridostigmine Bromide Extended-Release Tablets | Quetiapine Fumarate Extended-Release Tablets |
| Ramipril Tablets | Ranitidine Capsules | Ranitidine Effervescent Tablets for Oral Solution |
| Regorafenib Tablets | Remifentanil for Injection | Ribavirin Oral Solution |
| Rifapentine Tablets | Risedronate Sodium Delayed-Release Tablets | Rivastigmine Tartrate Oral Solution Posted as Pending |
| Rocuronium Bromide Injection | Roflumilast Tablets | Romifidine Hydrochloride Injection |
| Ropinirole Extended-Release Tablets | Rosuvastatin Calcium Tablets | Sapropterin Dihydrochloride Tablets |
| Saquinavir Mesylate Tablets | Selegiline Hydrochloride Orally Disintegrating Tablets | Sertaconazole Nitrate Cream |
| Sildenafil for Oral Suspension | Sildenafil Injection | Sildenafil Tablets |
| Sirolimus Oral Solution | Sirolimus Tablets | Sodium Fluoride and Triclosan Dental Paste |
| Sodium Nitroprusside Injection | Sodium Oxybate Oral Solution | Sodium Phenylacetate and Sodium Benzoate Injection |
| Sodium Phenylbutyrate Oral Powder | Sodium Phenylbutyrate Tablets | Sodium Phosphates Tablets |
| Sodium Picosulfate, Magnesium Oxide, and Citric Acid for Oral Solution | Sodium Salicylate and Sulfur Shampoo | Sodium Tetradecyl Sulfate Injection |
| Sorbitol Irrigation | Sotalol Hydrochloride Injection | Spinosad Topical Suspension |
| Streptozocin for Injection | Succimer Capsules | Sucralfate Oral Suspension |
| Sulconazole Nitrate Cream | Sulconazole Nitrate Topical Solution | Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution |
| Sulfanilamide Vaginal Cream | Sulfasalazine Oral Suspension | Sumatriptan and Naproxen Sodium Tablets |
| Synthetic Conjugated Estrogens Vaginal Cream | Tacrolimus Injection | Tacrolimus Ointment |
| Tafluprost Ophthalmic Solution | Talc Aerosol | Talc for Intrapleural Suspension |
| Tazarotene Cream | Tazarotene Topical Foam | Tazarotene Topical Gel |
| Telithromycin Tablets | Telmisartan and Amlodipine Tablets | Temozolomide Capsules |
| Temozolomide for Injection | Temsirolimus Injection | Tenofovir Disoproxil Fumarate Oral Powder |
| Tenofovir Disoproxil Fumarate Tablets Posted as Pending | Terbinafine Gel | Terbinafine Hydrochloride Cream |
| Terbinafine Hydrochloride Oral Granules | Terbinafine Hydrochloride Topical Spray | Terbinafine Topical Solution |
| Terconazole Vaginal Cream | Terconazole Vaginal Suppositories | Teriflunomide Tablets |
| Testosterone Implant | Testosterone Topical Gel | Testosterone Topical Solution |
| Testosterone Transdermal System | Tetrabenazine Tablets | Theophylline Elixir |
| Theophylline Extended-Release Tablets Posted as Pending | Tiagabine Hydrochloride Tablets | Tiludronic Acid Tablets |
| Tinidazole Tablets | Tioconazole Vaginal Ointment | Tiopronin Tablets |
| Tirofiban Injection | Tizanidine Capsules | Tobramycin In Sodium Chloride Injection |
| Tolterodine Capsules | Tolterodine Tartrate Tablets Received as Pending | Tolvaptan Tablets |
| Topotecan Capsules | Topotecan Injection | Toremifene Tablets |
| Torsemide Injection | Tranexamic Acid Injection | Tranexamic Acid Tablets |
| Treprostinil Inhalation Solution | Treprostinil Injection | Tretinoin Capsules |
| Trifluridine Ophthalmic Solution | Trimipramine Maleate Capsules | Triprolidine and Pseudoephedrine Hydrochlorides and Codeine Phosphate Syrup |
| Tromethamine Injection | Trospium Chloride Extended-Release Capsules Received as Pending | Trypan Blue Ophthalmic Solution |
| Ulipristal Acetate Tablets | Valganciclovir for Oral Solution | Valproic Acid Delayed-Release Capsules |
| Vardenafil Hydrochloride Tablets | Venlafaxine Extended-Release Tablets | Vincristine Sulfate Liposome Injection |
| Voriconazole for Injection | Voriconazole for Oral Suspension | Voriconazole Tablets |
| Zanamivir for Inhalation | Zileuton Extended-Release Tablets | Zileuton Tablets |
| Zinc Acetate Capsules | Ziprasidone Capsules | Ziprasidone Oral Suspension |
| Zolmitriptan Nasal Spray | Zolmitriptan Orally Disintegrating Tablets | Zolmitriptan Tablets |
| Zolpidem Tartrate Oral Spray | Zolpidem Tartrate Sublingual Tablets | |
Small Molecules Actives (Drug Substances) | Small Molecules Actives (Drug Products) | Inactive Ingredients
Inactive Ingredients
The following list contains monographs USP is seeking for inactive ingredients. This list has been updated as of March 4, 2013.
Monograph sponsors should consult USP's Guideline for Submitting Requests for Revision to the USP–NF. For additional information, or for comments about the list, contact Randy Kiser, M.S., M.B.A., rwk@usp.org.
MONOGRAPH NAME | ||
| Inactive Ingredients as of March 4, 2013 | ||
Abiraterone Acetate Tablets | Acetic Anhydride | Acetyltryptophan |
Acidic Sodium Aluminum Phosphate | Acrylic Acid Homopolymer | Aluminum Acetate |
Aluminum Hydroxide | Ammonium Nonoxynol4 Sulfate | Anise Extract |
Basic Sodium Aluminum Phosphate | Bovine Serum Albumin | Bronopol |
Calcium Alginate | Calcium Pyrophosphate | Calcium Sorbate |
Carboxymethylamylopectin Sodium | Cardamom | Carmine |
Cassia Oil | Cedar Leaf Oil | Ceresin |
Cetyl Lactate | Cinnamon | Cocoglycerides |
Cysteine | Decyl Oleate | Diatomaceous Earth |
Diisobutyl Adipate | Diisopropyl Adipate | Dimethyl Phthalate |
Dimethylacetamide | D-Mannose | Ethyl Hexanediol |
Ethylhexyl Hydroxystearate | Glyceryl Palmitate | Glyceryl Palmitostearate |
Glyceryl Stearate | Glyceryl Stearate Se | Glycine Hydrochloride |
Hexyldecanol | Hydrogenated Lanolin | Hydrous Lanolin |
Hydroxymethyl Cellulose | Invert Sugar | Isopropyl Isostearate |
Karaya Gum | Lauryl Lactate | Lavender |
Lime Oil | Locust Bean Gum | Myristyl Lactate |
Myristyl Myristate | Peg-40 Sorbitan Diisostearate | Phenethyl Alcohol |
Polidronium Chloride | Polyethylene | Polyethylene Glycol 3350 |
Polypropylene Glycol | Potassium Glycerophosphate | Propenyl Guaethol |
Propylene Glycol Diacetate | Propylene Glycol Dicaprylate | Sodium Acid Pyrophosphate |
Sodium Aluminosilicate | Sodium Caseinate | Sodium Diacetate |
Sodium Erythorbate | Sodium Lauroyl Sarcosinate | Sodium Polyphosphates Glassy |
Sodium Pyrophosphate | Sodium Sesquicarbonate | Sodium Thiomalate |
Sodium Trimetaphosphate | Sodium Tripolyphosphate | Soy Polysaccharides |
Soybean Phosphatidylcholine | Stearyl Citrate | Succinylated Monoglycerides |
T-Butylhydroquinone | Turpentine Oil | Wheat Gluten |
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