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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 68071-4430-5  NuCare Pharmaceuticals,Inc.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 21695-547-04  Rebel Distributors Corp.  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE ANHYDROUS 10191-1035-2  Remedy Makers    HUMAN PRESCRIPTION DRUG  unapproved homeopathic 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-474-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63187-815-15  Proficient Rx LP  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 71610-111-90  Aphena Pharma Solutions - Tennessee, LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 71335-0336-2  Bryant Ranch Prepack  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 61919-273-90  DirectRX  ANDA088629  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 71335-1522-5  Bryant Ranch Prepack  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 63304-561-05  Sun Pharmaceutical Industries, Inc.  ANDA087083  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 0406-0485-05  SpecGx LLC  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 12634-526-96  Apotheca, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50383-340-17  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 52959-446-24  H.J. Harkins Company, Inc.  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; BUTALBITAL; CODEINE PHOSPHATE; CAFFEINE 71335-0653-2  Bryant Ranch Prepack  ANDA075929  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE SULFATE 0527-1698-91  Lannett Company, Inc.  ANDA203046  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 21695-242-60  Rebel Distributors Corp.  ANDA040419  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 52959-003-45  H.J. Harkins Company, Inc.  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-882-40  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 67544-882-53  Aphena Pharma Solutions - Tennessee, LLC  ANDA089805  HUMAN PRESCRIPTION DRUG  ANDA 
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 0054-3000-01  Hikma Pharmaceuticals USA Inc.  ANDA215138  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 33261-002-60  Aidarex Pharmaceuticals LLC  ANDA089828  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 63304-562-05  Sun Pharmaceutical Industries, Inc.  ANDA085868  HUMAN PRESCRIPTION DRUG  ANDA 
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 0121-0925-16  PAI Holdings, LLC  ANDA040660  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 0121-0504-04  PAI Holdings, LLC  ANDA087508  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 27808-065-01  Tris Pharma Inc  ANDA200386  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 50383-340-15  Akorn  ANDA040119  HUMAN PRESCRIPTION DRUG  ANDA 
ACETAMINOPHEN; CODEINE PHOSPHATE 53489-160-05  Mutual Pharmaceutical Company, Inc.  ANDA089672  HUMAN PRESCRIPTION DRUG  ANDA 
CODEINE PHOSPHATE; ACETAMINOPHEN 13107-058-01  Aurolife Pharma, LLC  ANDA202800  HUMAN PRESCRIPTION DRUG  ANDA 
CAFFEINE; ACETAMINOPHEN; DIHYDROCODEINE BITARTRATE 63187-705-60  Proficient Rx LP  ANDA204785  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
601-630 631-660 661-690 691-720 721-750 751-762

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