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 |
| ACETAMINOPHEN; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE | 0054-0650-25 | Hikma Pharmaceuticals USA Inc. | ANDA215138 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; BUTALBITAL; 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 |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-0775-04 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-0775-08 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-0775-16 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE | 0121-0925-16 | PAI Holdings, LLC | ANDA040660 | HUMAN PRESCRIPTION DRUG | ANDA |
| CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 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 |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-1550-00 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| GUAIFENESIN; CODEINE PHOSPHATE | 0121-1550-10 | PAI Holdings, LLC | M012 | HUMAN OTC DRUG | OTC Monograph Drug |
| GUAIFENESIN; CODEINE PHOSPHATE | 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 |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0406-0484-01 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0406-0484-03 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0406-0484-10 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0406-0484-20 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
| ACETAMINOPHEN; CODEINE PHOSPHATE | 0406-0484-23 | SpecGx LLC | ANDA040419 | HUMAN PRESCRIPTION DRUG | ANDA |
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| 301-330 | 331-360 | 361-390 | 391-420 | 421-450 | 451-480 | 481-510 | 511-540 | 541-570 | 571-600 |
| 601-630 | 631-660 | 661-690 | 691-720 | 721-750 | 751-753 |
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