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 |
|---|---|---|---|---|---|
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-446-02 | H.J. Harkins Company, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-3011-6 | A-S Medication Solutions | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 17856-0079-5 | ATLANTIC BIOLOGICALS COPR. | ANDA040119 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-446-30 | H.J. Harkins Company, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 50090-0215-0 | A-S Medication Solutions | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-1818-5 | Bryant Ranch Prepack | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-3011-7 | A-S Medication Solutions | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | 42195-840-10 | Xspire Pharma, Llc | ANDA204785 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 50383-805-04 | Akorn | ANDA040674 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-059-99 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 63629-3031-9 | Bryant Ranch Prepack | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 27808-065-02 | Tris Pharma Inc | ANDA200386 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 63187-291-04 | Proficient Rx LP | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-882-70 | Aphena Pharma Solutions - Tennessee, LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 54348-015-01 | PharmPak, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 70518-3705-0 | REMEDYREPACK INC. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-28 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71610-111-70 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50436-3227-7 | Unit Dose Services | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 0054-0650-25 | Hikma Pharmaceuticals USA Inc. | ANDA215138 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71335-1522-7 | Bryant Ranch Prepack | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-5010-6 | NuCare Pharmaceuticals,Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71610-111-54 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 70408-185-31 | Nostrum Laboratories, Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 58118-4484-8 | Clinical Solutions Wholesale, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 53002-0102-2 | RPK Pharmaceuticals, Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-3061-4 | NuCare Pharmaceuticals, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE | 55045-1266-8 | Dispensing Solutions, Inc. | ANDA040660 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 21695-242-30 | Rebel Distributors Corp. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-3100-6 | NuCare Pharmaceuticals, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 64850-643-12 | Elite Laboratories, Inc. | ANDA212418 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 63187-106-60 | Proficient Rx LP | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 21695-336-16 | Rebel Distributors Corp. | ANDA040650 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE ANHYDROUS | 10191-1037-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0336-4 | Bryant Ranch Prepack | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0336-5 | Bryant Ranch Prepack | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0484-62 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0701-3 | Bryant Ranch Prepack | ANDA088629 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71335-0256-9 | Bryant Ranch Prepack | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-5200-1 | A-S Medication Solutions | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-5200-3 | A-S Medication Solutions | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67046-903-15 | Contract Pharmacy Services-PA | ANDA088628 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 33261-001-02 | Aidarex Pharmaceuticals LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE | 10191-1045-2 | Ethical Nutritional, LLC | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 61919-023-60 | DIRECT RX | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 63629-3031-3 | Bryant Ranch Prepack | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0440-7026-30 | Liberty Pharmaceuticals, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 33261-001-90 | Aidarex Pharmaceuticals LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67046-929-30 | Contract Pharmacy Services-PA | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-0701-8 | Bryant Ranch Prepack | ANDA088629 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 33261-001-15 | Aidarex Pharmaceuticals LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-058-01 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CAFFEINE; ACETAMINOPHEN; BUTALBITAL; CODEINE PHOSPHATE | 72162-1591-2 | Bryant Ranch Prepack | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-4430-5 | NuCare Pharmaceuticals,Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 71335-0194-7 | Bryant Ranch Prepack | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE SULFATE | 0054-0244-25 | Hikma Pharmaceuticals USA Inc. | NDA022402 | HUMAN PRESCRIPTION DRUG | NDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 61919-328-71 | Direct RX | ANDA088628 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 68071-3100-5 | NuCare Pharmaceuticals, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 33261-002-12 | Aidarex Pharmaceuticals LLC | ANDA089828 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-882-55 | Aphena Pharma Solutions - Tennessee, LLC | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE SULFATE | 0527-1699-01 | Lannett Company, Inc. | ANDA203046 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-1846-2 | Bryant Ranch Prepack | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-1846-7 | Bryant Ranch Prepack | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71930-056-12 | Eywa Pharma Inc | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE ANHYDROUS | 10191-1033-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 53217-213-01 | Aidarex Pharmaceuticals LLC | ANDA040119 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 70518-3980-0 | REMEDYREPACK INC. | ANDA040779 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 72162-2002-1 | Bryant Ranch Prepack | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 68788-7835-6 | Preferred Pharmaceuticals Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67544-002-70 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 17856-0079-1 | ATLANTIC BIOLOGICALS COPR. | ANDA040119 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-446-00 | H.J. Harkins Company, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 53002-0102-5 | RPK Pharmaceuticals, Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 50090-3011-4 | A-S Medication Solutions | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71610-111-60 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71335-1846-0 | Bryant Ranch Prepack | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71205-001-20 | Proficient Rx LP | ANDA088628 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 21695-242-28 | Rebel Distributors Corp. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE ANHYDROUS | 10191-1034-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 68387-250-40 | Keltman Pharmaceuticals, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-04 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN; CAFFEINE; BUTALBITAL | 79739-7028-5 | LGM Pharma Solutions, LLC | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 17856-0804-5 | Atlantic Biologicals Corps | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 63629-1190-1 | Bryant Ranch Prepack | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 52959-118-08 | H.J. Harkins Company,Inc. | ANDA088875 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 66336-059-15 | Dispensing Solutions, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE ANHYDROUS | 10191-1036-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 68387-250-30 | Keltman Pharmaceuticals, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 63629-1185-1 | Bryant Ranch Prepack | ANDA211610 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 53217-370-20 | Aidarex Pharmaceuticals LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0483-01 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 70518-3575-0 | REMEDYREPACK INC. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 70166-555-05 | Lohxa | ANDA088875 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 71205-001-60 | Proficient Rx LP | ANDA088628 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71610-111-53 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-06 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67296-0544-3 | RedPharm Drug Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE | 0527-1312-01 | Lannett Company, Inc. | ANDA074951 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 53489-160-02 | Mutual Pharmaceutical Company, Inc. | ANDA089672 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-55 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
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