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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 0121-0775-04  Pharmaceutical Associates, Inc.  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 50383-087-05  Hi-Tech Pharmacal Co., Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 43378-121-04  codaDOSE Incorporated  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 60575-616-16  Respa Pharmaceuticals, Inc  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 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 29978-420-16  Capital Pharmaceutical, LLC  part341  HUMAN OTC DRUG  OTC monograph final 
PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 50991-901-16  Poly Pharmaceuticals, Inc.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 0603-1075-54  Qualitest Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 0603-1075-56  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 0603-1329-58  Qualitest Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 70147-414-16  Glendale Inc  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 69543-253-16  Virtus Pharmaceuticals  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
GUAIFENESIN; CODEINE PHOSPHATE 61786-968-45  REMEDYREPACK INC.  part341  HUMAN OTC DRUG  OTC monograph final 
GUAIFENESIN; CODEINE PHOSPHATE 57963-103-16  The Generic Pharmaceutical Company  part341  HUMAN OTC DRUG  OTC MONOGRAPH FINAL 
ACETAMINOPHEN; CODEINE PHOSPHATE 46672-561-16  Mikart, Inc.  ANDA089450  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 12634-907-28  Apotheca Inc.  ANDA090180  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-3061-6  NuCare Pharmaceuticals, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-3059-6  NuCarePharmaceuticals, Inc.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 43063-554-06  PD-Rx Pharmaceuticals, Inc.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-55  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-00  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 54569-2523-6  A-S Medication Solutions LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL 52544-082-01  Watson Pharma, Inc.  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53217-213-01  Aidarex Pharmaceuticals LLC  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-28  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-90  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; CODEINE PHOSPHATE; BUTALBITAL; ASPIRIN 0722-6094-01  Nexgen Pharma, Inc.  ANDA075231  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 66336-059-40  Dispensing Solutions, Inc.  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
601-630 631-660 661-690 691-720 721-750 751-773

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