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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
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 50991-901-16  Poly Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0603-1329-58  Qualitest Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 50383-087-07  Hi-Tech Pharmacal Co., Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 17856-0500-5  ATLANTIC BIOLOGICALS CORP.  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 60575-212-16  Respa Pharmaceuticals, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; BROMPHENIRAMINE MALEATE 23359-023-16  Centurion Labs, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 60575-515-16  Respa Pharmaceuticals, Inc  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-0775-16  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 50090-0423-0  A-S Medication Solutions LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 61919-110-04  DirectRX  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 58657-500-16  Method Pharmaceuticals, LLC  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 69543-252-16  Virtus Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 58407-920-16  Magna Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 29978-420-15  Capital Pharmaceutical, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0121-1550-00  Pharmaceutical Associates, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
ACETAMINOPHEN; CODEINE PHOSPHATE 55289-449-30  PD-Rx Pharmaceuticals, Inc.  ANDA089990  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 43063-014-06  PD-Rx Pharmaceuticals, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-491-90  Proficient Rx LP  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
.GAMMA.-AMINOBUTYRIC ACID; CODEINE PHOSPHATE; ACETAMINOPHEN 68405-398-36  Physician Therapeutics    HUMAN PRESCRIPTION DRUG  unapproved drug other 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 50383-805-04  Hi-Tech Pharmacal Co., Inc.  ANDA040674  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN 54868-1037-5  PHYSICIANS TOTAL CARE, INC  ANDA074359  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33358-001-60  RxChange Co.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 50090-1572-0  A-S Medication Solutions  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63629-3031-6  Bryant Ranch Prepack  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68788-9229-1  Preferred Pharmaceuticals, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-882-90  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 0440-7026-40  Liberty Pharmaceuticals, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 55289-916-90  PD-Rx Pharmaceuticals, Inc.  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-002-90  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 54569-8305-0  A-S Medication Solutions LLC  ANDA089805  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
601-630 631-660 661-690 691-720 721-750 751-770

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