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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
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-002-80  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-5010-4  NuCare Pharmaceuticals,Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 68387-250-30  Keltman Pharmaceuticals, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 49999-060-10  Quality Care Products, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50383-340-15  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 68071-3061-2  NuCare Pharmaceuticals, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50090-5200-1  A-S Medication Solutions  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0336-0  Bryant Ranch Prepack  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50090-1935-0  A-S Medication Solutions  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 0121-0504-00  PAI Holdings, LLC  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-160-05  Mutual Pharmaceutical Company, Inc.  ANDA089672  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-4533-8  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 13107-060-30  Aurolife Pharma, LLC  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 79739-7028-1  LGM Pharma Solutions, LLC  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-882-40  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-4533-4  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 17856-0605-1  ATLANTIC BIOLOGICALS CORP.  ANDA088875  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 68071-2800-6  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 68788-7835-3  Preferred Pharmaceuticals Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-160-01  Mutual Pharmaceutical Company, Inc.  ANDA089672  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71930-055-52  Eywa Pharma Inc  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 65162-694-90  Amneal Pharmaceuticals LLC  ANDA200963  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-446-60  H.J. Harkins Company, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 71335-1818-8  Bryant Ranch Prepack  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
ASPIRIN; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE 69238-1993-1  Amneal Pharmaceuticals of New York, LLC  ANDA074951  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68788-7859-6  Preferred Pharmaceuticals Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 65162-033-11  Amneal Pharmaceuticals LLC  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 65162-033-50  Amneal Pharmaceuticals LLC  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 12634-907-16  Apotheca Inc.  ANDA090180  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 64850-641-12  Elite Laboratories, Inc.  ANDA212418  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
601-630 631-660 661-690 691-720 721-750 751-753

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