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 |
|---|---|---|---|---|---|
| GUAIFENESIN; CODEINE PHOSPHATE | 69367-272-16 | Westminster Pharmaceuticals, LLC | part341 | HUMAN OTC DRUG | OTC MONOGRAPH FINAL |
| GUAIFENESIN; CODEINE PHOSPHATE | 50383-087-10 | Akorn Operating Company LLC | part341 | HUMAN OTC DRUG | OTC monograph final |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 70518-3051-0 | REMEDYREPACK INC. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67544-002-20 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0406-0484-10 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 68071-4673-4 | NuCare Pharmaceuticals,Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 63304-561-05 | Sun Pharmaceutical Industries, Inc. | ANDA087083 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 10544-100-10 | Blenheim Pharmacal, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67544-002-53 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 67296-1516-6 | RedPharm Drug, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE SULFATE | 0054-0244-25 | Hikma Pharmaceuticals USA Inc. | NDA022402 | HUMAN PRESCRIPTION DRUG | NDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 52959-446-90 | H.J. Harkins Company, Inc. | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 13107-060-05 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 49999-060-12 | Lake Erie Medical DBA Quality Care Products LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 53002-0102-3 | RPK Pharmaceuticals, Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 64850-643-12 | Elite Laboratories, Inc. | ANDA212418 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67544-002-40 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-04 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 67544-002-55 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 53489-161-02 | Mutual Pharmaceutical Company, Inc. | ANDA089673 | HUMAN PRESCRIPTION DRUG | ANDA |
| CAFFEINE; ACETAMINOPHEN; DIHYDROCODEINE BITARTRATE | 63187-705-90 | Proficient Rx LP | ANDA204785 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 61919-053-30 | Direct_Rx | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 50383-340-17 | Akorn | ANDA040119 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 49999-060-24 | Lake Erie Medical DBA Quality Care Products LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 71610-111-90 | Aphena Pharma Solutions - Tennessee, LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 21695-242-28 | Rebel Distributors Corp. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 53489-161-01 | Mutual Pharmaceutical Company, Inc. | ANDA089673 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 10544-100-15 | Blenheim Pharmacal, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 21695-336-04 | Rebel Distributors Corp. | ANDA040650 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 61502-903-97 | EPM Packaging Inc | ANDA088627 | HUMAN PRESCRIPTION DRUG | ANDA |
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| 601-630 | 631-660 | 661-690 | 691-720 | 721-750 | 751-762 |
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