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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 61919-472-90  DIRECT RX  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-106-15  Proficient Rx LP  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50090-5201-0  A-S Medication Solutions  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 68071-4475-6  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 52959-003-45  H.J. Harkins Company, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 61502-903-97  EPM Packaging Inc  ANDA088627  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50090-1933-7  A-S Medication Solutions  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE 71335-0194-5  Bryant Ranch Prepack  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 33261-001-14  Aidarex Pharmaceuticals LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 63629-3031-2  Bryant Ranch Prepack  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE SULFATE 0527-1698-91  Lannett Company, Inc.  ANDA203046  HUMAN PRESCRIPTION DRUG  ANDA 
BUTALBITAL; ASPIRIN; CODEINE PHOSPHATE; CAFFEINE 51991-074-05  Breckenridge Pharmaceutical, Inc.  ANDA075231  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-002-40  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-161-01  Mutual Pharmaceutical Company, Inc.  ANDA089673  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 67544-474-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 61919-328-30  Direct RX  ANDA088628  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 53002-0101-5  RPK Pharmaceuticals, Inc.  ANDA040779  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 52959-118-08  H.J. Harkins Company,Inc.  ANDA088875  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-446-90  H.J. Harkins Company, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71610-111-75  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-161-02  Mutual Pharmaceutical Company, Inc.  ANDA089673  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 63629-3031-1  Bryant Ranch Prepack  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 10544-100-15  Blenheim Pharmacal, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 42254-145-60  Rebel Distributors Corp.  ANDA088629  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 33261-002-15  Aidarex Pharmaceuticals LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE 71335-0194-4  Bryant Ranch Prepack  ANDA076560  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE ANHYDROUS 10191-1038-2  Remedy Makers    HUMAN PRESCRIPTION DRUG  unapproved homeopathic 
CODEINE PHOSPHATE; ACETAMINOPHEN 68071-2681-6  NuCare Pharmaceuticals,Inc.  ANDA211610  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-002-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; BUTALBITAL; ACETAMINOPHEN; CODEINE PHOSPHATE 71335-0653-5  Bryant Ranch Prepack  ANDA075929  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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