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 SULFATE | 0054-0243-24 | Hikma Pharmaceuticals USA Inc. | NDA022402 | HUMAN PRESCRIPTION DRUG | NDA |
| CODEINE SULFATE | 0054-0244-24 | Hikma Pharmaceuticals USA Inc. | NDA022402 | HUMAN PRESCRIPTION DRUG | NDA |
| CODEINE SULFATE | 0054-0244-25 | Hikma Pharmaceuticals USA Inc. | NDA022402 | HUMAN PRESCRIPTION DRUG | NDA |
| CODEINE SULFATE | 0054-0245-25 | Hikma Pharmaceuticals USA Inc. | NDA022402 | HUMAN PRESCRIPTION DRUG | NDA |
| CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ACETAMINOPHEN | 0054-0650-25 | Hikma Pharmaceuticals USA Inc. | ANDA215138 | HUMAN PRESCRIPTION DRUG | ANDA |
| BUTALBITAL; CODEINE PHOSPHATE; CAFFEINE; ACETAMINOPHEN | 0054-3000-01 | Hikma Pharmaceuticals USA Inc. | ANDA215138 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0121-0504-00 | PAI Holdings, LLC | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0121-0504-04 | PAI Holdings, LLC | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0121-0504-05 | PAI Holdings, LLC | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0121-0504-16 | PAI Holdings, LLC | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; GUAIFENESIN | 0121-0775-04 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| CODEINE PHOSPHATE; GUAIFENESIN | 0121-0775-08 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| CODEINE PHOSPHATE; GUAIFENESIN | 0121-0775-16 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE | 0121-0925-16 | PAI Holdings, LLC | ANDA040660 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 0121-0928-16 | PAI Holdings, LLC | ANDA040650 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0121-1008-00 | PAI Holdings, LLC | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0121-1008-12 | PAI Holdings, LLC | ANDA087508 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; GUAIFENESIN | 0121-1550-00 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| CODEINE PHOSPHATE; GUAIFENESIN | 0121-1550-10 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| CODEINE PHOSPHATE; GUAIFENESIN | 0121-1550-40 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-1775-00 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-1775-05 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-1775-10 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-1775-40 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0483-01 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0484-01 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0484-03 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0484-10 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0484-20 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0484-23 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0484-50 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0484-62 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0485-01 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 0406-0485-05 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0440-7026-30 | Liberty Pharmaceuticals, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0440-7026-40 | Liberty Pharmaceuticals, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0440-7027-30 | Liberty Pharmaceuticals, Inc. | ANDA089828 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0440-7027-40 | Liberty Pharmaceuticals, Inc. | ANDA089828 | HUMAN PRESCRIPTION DRUG | ANDA |
| BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE | 0527-1312-01 | Lannett Company, Inc. | ANDA074951 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE SULFATE | 0527-1698-01 | Lannett Company, Inc. | ANDA203046 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE SULFATE | 0527-1698-91 | Lannett Company, Inc. | ANDA203046 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE SULFATE | 0527-1699-01 | Lannett Company, Inc. | ANDA203046 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; BUTALBITAL; CODEINE PHOSPHATE; CAFFEINE | 0591-2641-01 | Actavis Pharma, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| BUTALBITAL; CAFFEINE; ACETAMINOPHEN; CODEINE PHOSPHATE | 0591-3220-01 | Actavis Pharma, Inc. | NDA020232 | HUMAN PRESCRIPTION DRUG | NDA authorized generic |
| CODEINE PHOSPHATE; GUAIFENESIN | 0682-0475-16 | Marnel Pharmaceuticals, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| CODEINE PHOSPHATE; ASPIRIN; BUTALBITAL; CAFFEINE | 0722-6094-01 | Nexgen Pharma, Inc. | ANDA075231 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ASPIRIN; BUTALBITAL; CAFFEINE | 0722-6094-05 | Nexgen Pharma, Inc. | ANDA075231 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 0722-6670-01 | Nexgen Pharma, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 0722-6670-05 | Nexgen Pharma, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| BUTALBITAL; CAFFEINE; ACETAMINOPHEN; CODEINE PHOSPHATE | 0722-7028-01 | Nexgen Pharma, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| BUTALBITAL; CAFFEINE; ACETAMINOPHEN; CODEINE PHOSPHATE | 0722-7028-05 | Nexgen Pharma, Inc. | ANDA076560 | HUMAN PRESCRIPTION DRUG | ANDA |
| CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE | 0722-7184-01 | Nexgen Pharma, Inc. | NDA206323 | HUMAN PRESCRIPTION DRUG | NDA |
| CODEINE ANHYDROUS | 10191-1033-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE ANHYDROUS | 10191-1034-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE ANHYDROUS | 10191-1035-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE ANHYDROUS | 10191-1036-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE ANHYDROUS | 10191-1037-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE ANHYDROUS | 10191-1038-2 | Remedy Makers | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE | 10191-1045-2 | Ethical Nutritional, LLC | HUMAN PRESCRIPTION DRUG | unapproved homeopathic | |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 10544-032-15 | Blenheim Pharmacal, Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 10544-032-20 | Blenheim Pharmacal, Inc. | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 10544-100-10 | Blenheim Pharmacal, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 10544-100-15 | Blenheim Pharmacal, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 10544-100-20 | Blenheim Pharmacal, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-00 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-01 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-40 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-50 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-55 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-59 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-65 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-66 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-71 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-80 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-82 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-85 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-91 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-94 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 12634-526-96 | Apotheca, Inc. | ANDA089805 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-02 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-04 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-06 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-08 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-16 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-28 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 12634-907-32 | Apotheca Inc. | ANDA090180 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-02 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-04 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-06 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-08 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-16 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-28 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 12634-909-32 | Apotheca Inc | ANDA040151 | HUMAN PRESCRIPTION DRUG | ANDA |
| GUAIFENESIN; CODEINE PHOSPHATE | 12634-969-04 | Apotheca, Inc | part341 | HUMAN OTC DRUG | OTC monograph final |
| CODEINE PHOSPHATE; ACETAMINOPHEN | 12634-975-06 | Apotheca Inc. | ANDA040119 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-058-01 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-058-05 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-058-30 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-058-99 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 13107-059-01 | Aurolife Pharma, LLC | ANDA202800 | HUMAN PRESCRIPTION DRUG | ANDA |
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