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U.S. Department of Health and Human Services

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 33358-002-30  RxChange Co.  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0406-0484-23  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0406-0484-50  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0406-0484-62  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 0406-0485-01  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
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 0406-0484-20  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0406-0485-05  SpecGx LLC  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 60760-581-30  ST. MARY'S MEDICAL PARK PHARMACY  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 54879-005-16  STI Pharma LLC  ANDA088704  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63304-562-01  Sun Pharmaceutical Industries, Inc.  ANDA085868  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63304-562-05  Sun Pharmaceutical Industries, Inc.  ANDA085868  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63304-561-05  Sun Pharmaceutical Industries, Inc.  ANDA087083  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63304-561-01  Sun Pharmaceutical Industries, Inc.  ANDA087083  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63304-562-10  Sun Pharmaceutical Industries, Inc.  ANDA085868  HUMAN PRESCRIPTION DRUG  ANDA 
GUAIFENESIN; CODEINE PHOSPHATE 57963-103-04  The Generic Pharmaceutical Company  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 57963-103-16  The Generic Pharmaceutical Company  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 27808-065-02  Tris Pharma Inc  ANDA200386  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 27808-065-01  Tris Pharma Inc  ANDA200386  HUMAN PRESCRIPTION DRUG  ANDA 
GUAIFENESIN; CODEINE PHOSPHATE 50436-2520-1  Unit Dose Services  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
ACETAMINOPHEN; CODEINE PHOSPHATE 50436-3227-9  Unit Dose Services  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50436-3227-1  Unit Dose Services  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50436-3227-2  Unit Dose Services  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50436-3227-7  Unit Dose Services  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 50436-1029-1  Unit Dose Services  ANDA040650  HUMAN PRESCRIPTION DRUG  ANDA 
GUAIFENESIN; CODEINE PHOSPHATE 69367-272-16  Westminster Pharmaceuticals, LLC  M012  HUMAN OTC DRUG  OTC MONOGRAPH DRUG 
1-30 31-60 61-90 91-120 121-150 151-180 181-210 211-240 241-270 271-300
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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