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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 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 
CAFFEINE; ACETAMINOPHEN; CODEINE PHOSPHATE; BUTALBITAL 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 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 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 
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
601-630 631-660 661-690 691-720 721-735

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