FDA Application
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NDC Search Results on Active Ingredient: codeine
Click on Active Ingredient to view the label.
| Ingredient Name | NDC | Company Name | Application Number or Regulatory Citation | Product Type | Marketing Category |
|---|---|---|---|---|---|
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-002-60 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-446-15 | H.J. Harkins Company, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71930-054-52 | Eywa Pharma Inc | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 45865-439-30 | Medsource Pharmaceuticals | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-4749-6 | NuCare Pharmaceuticals,Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71335-0256-5 | Bryant Ranch Prepack | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 43353-010-50 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71610-111-45 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-003-28 | H.J. Harkins Company, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-08 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 0121-0928-16 | PAI Holdings, LLC | ANDA040650 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50383-079-16 | Akorn | ANDA040119 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 63187-271-04 | Proficient Rx LP | ANDA040650 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71335-1522-9 | Bryant Ranch Prepack | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71335-1522-6 | Bryant Ranch Prepack | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 12634-975-06 | Apotheca Inc. | ANDA040119 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-882-90 | Aphena Pharma Solutions - Tennessee, LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-002-93 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-4430-3 | NuCare Pharmaceuticals,Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-40 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0121-0504-16 | PAI Holdings, LLC | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-882-20 | Aphena Pharma Solutions - Tennessee, LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CAFFEINE; DIHYDROCODEINE BITARTRATE; ACETAMINOPHEN | 63187-705-30 | Proficient Rx LP | ANDA204785 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-4611-1 | A-S Medication Solutions | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67296-1516-2 | RedPharm Drug, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67296-0065-6 | RedPharm Drug | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| BUTALBITAL; CODEINE PHOSPHATE; CAFFEINE; ACETAMINOPHEN | 0054-3000-01 | Hikma Pharmaceuticals USA Inc. | ANDA215138 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 52544-082-01 | Actavis Pharma, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-4533-2 | NuCare Pharmaceuticals,Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71930-056-52 | Eywa Pharma Inc | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 66336-059-30 | Dispensing Solutions, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 63187-106-30 | Proficient Rx LP | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 52959-118-04 | H.J. Harkins Company,Inc. | ANDA088875 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 51655-808-52 | Northwind Pharmaceuticals | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 63629-3031-6 | Bryant Ranch Prepack | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 68788-7835-3 | Preferred Pharmaceuticals Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; BUTALBITAL; CODEINE PHOSPHATE; CAFFEINE | 51991-073-01 | Breckenridge Pharmaceutical, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-1846-4 | Bryant Ranch Prepack | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 33261-001-20 | Aidarex Pharmaceuticals LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-003-25 | H.J. Harkins Company, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 43353-010-45 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 42254-140-04 | Rebel Distributors Corp. | ANDA088763 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 33261-002-28 | Aidarex Pharmaceuticals LLC | ANDA089828 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 68387-250-90 | Keltman Pharmaceuticals, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-446-20 | H.J. Harkins Company, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-3100-4 | NuCare Pharmaceuticals, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 66336-059-12 | Dispensing Solutions, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 63187-470-90 | Proficient Rx LP | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 64950-374-16 | Genus Lifesciences Inc. | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 63187-491-30 | Proficient Rx LP | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-65 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-08 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 71335-0194-1 | Bryant Ranch Prepack | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-059-05 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ASPIRIN; BUTALBITAL; CAFFEINE | 69238-1993-1 | Amneal Pharmaceuticals of New York, LLC | ANDA074951 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE SULFATE | 0054-0243-24 | Hikma Pharmaceuticals USA Inc. | NDA022402 | HUMAN PRESCRIPTION DRUG | NDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-3011-1 | A-S Medication Solutions | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0701-2 | Bryant Ranch Prepack | ANDA088629 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 49999-060-50 | Quality Care Products, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 63187-106-90 | Proficient Rx LP | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 61502-903-30 | EPM Packaging Inc | ANDA088627 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 33358-002-30 | RxChange Co. | ANDA089828 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 63629-3031-7 | Bryant Ranch Prepack | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 10544-100-20 | Blenheim Pharmacal, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50436-3227-9 | Unit Dose Services | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 61919-053-60 | DIRECT RX | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 49999-026-60 | Quality Care Products LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71205-001-90 | Proficient Rx LP | ANDA088628 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 70518-2989-0 | REMEDYREPACK INC. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71930-055-12 | Eywa Pharma Inc | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 53002-0102-1 | RPK Pharmaceuticals, Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0653-5 | Bryant Ranch Prepack | ANDA075929 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-66 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 33261-001-25 | Aidarex Pharmaceuticals LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0336-6 | Bryant Ranch Prepack | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0336-9 | Bryant Ranch Prepack | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-1934-6 | A-S Medication Solutions | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-003-60 | H.J. Harkins Company, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 33261-002-30 | Aidarex Pharmaceuticals LLC | ANDA089828 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71335-0256-4 | Bryant Ranch Prepack | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 61919-484-71 | Direct_Rx | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0701-9 | Bryant Ranch Prepack | ANDA088629 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 64950-374-04 | Genus Lifesciences Inc. | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-4610-7 | A-S Medication Solutions | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 60760-466-30 | St. Mary's Medical Park Pharmacy | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 61502-903-15 | EPM Packaging Inc | ANDA088627 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN; CAFFEINE; BUTALBITAL | 79739-7028-1 | LGM Pharma Solutions, LLC | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-059-30 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 65162-033-11 | Amneal Pharmaceuticals LLC | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE | 0121-0925-16 | PAI Holdings, LLC | ANDA040660 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 76420-103-03 | Asclemed USA, Inc. | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 49999-060-24 | Quality Care Products, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-002-75 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 70752-139-06 | QUAGEN PHARMACEUTICALS LLC | ANDA214238 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE SULFATE | 0054-0245-25 | Hikma Pharmaceuticals USA Inc. | NDA022402 | HUMAN PRESCRIPTION DRUG | NDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67544-474-30 | Aphena Pharma Solutions - Tennessee, LLC | ANDA089828 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67544-474-70 | Aphena Pharma Solutions - Tennessee, LLC | ANDA089828 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-002-55 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-3100-8 | NuCare Pharmaceuticals, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-060-30 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
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