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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
GUAIFENESIN; CODEINE PHOSPHATE 0121-0775-16  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 70156-112-04  Noble Pharmaceuticals, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 63187-117-04  Proficient Rx LP  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 23359-040-16  Centurion Labs, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1775-10  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 58657-500-16  Method Pharmaceuticals, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; TRIPROLIDINE HYDROCHLORIDE 28595-250-16  Allegis Pharmaceuticals, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 54932-208-86  BioRamo, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 0603-1078-58  Qualitest Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; BROMPHENIRAMINE MALEATE 12830-754-30  R.A. McNeil Company  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 69543-252-16  Virtus Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 54569-3146-0  A-S Medication Solutions LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-04  Hi-Tech Pharmacal Co., Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORCYCLIZINE HYDROCHLORIDE 24839-348-10  SJ Pharmaceuticals, LLC    HUMAN PRESCRIPTION DRUG  unapproved drug other 
ACETAMINOPHEN; CODEINE PHOSPHATE 16590-361-04  STAT RX USA LLC  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 54868-1029-1  PHYSICIANS TOTAL CARE, INC  ANDA040650  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 66267-001-60  NuCare Pharmaceuticals, Inc.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0093-0150-01  Teva Pharmaceuticals USA, Inc.  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-0007-9  A-S Medication Solutions  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-0007-3  A-S Medication Solutions  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-002-60  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 43353-010-90  Aphena Pharma Solutions - Tennessee, LLC  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 17856-0079-1  Atlantic Biologicals Corps  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE SULFATE 54868-2541-2  PHYSICIANS TOTAL CARE, INC  NDA022402  HUMAN PRESCRIPTION DRUG  NDA 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 0472-1629-08  Actavis Mid Atlantic LLC  ANDA088764  HUMAN PRESCRIPTION DRUG  ANDA 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 0472-1629-16  Actavis Mid Atlantic LLC  ANDA088764  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL 0722-6670-05  Nexgen Pharma, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-85  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-1574-0  A-S Medication Solutions  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-243-60  Rebel Distributors Corp.  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
601-630 631-660 661-690 691-720 721-750 751-771

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