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U.S. Department of Health and Human Services

FDA Label Search

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NDC Search Results on Proprietary Name: gemcitabine

Click on Proprietary Name to view the label.

Proprietary Name NDC Company Name Application Number or Regulatory Citation Product Type Marketing Category
Gemcitabine hydrochloride 62128-0383-1  Evonik Corporation    BULK INGREDIENT  Export only 
Gemcitabine hydrochloride 62128-0383-6  Evonik Corporation    BULK INGREDIENT  Export only 
Gemcitabine 0409-0185-01  Hospira, Inc.  ANDA078339  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 0409-0186-01  Hospira, Inc.  ANDA078339  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE HYDROCHLORIDE 69097-313-37  Cipla USA Inc.  ANDA078759  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE HYDROCHLORIDE 69097-314-42  Cipla USA Inc.  ANDA078759  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 0409-0187-01  Hospira, Inc.  ANDA079183  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-126-00  Fresenius Kabi USA, LLC  ANDA090242  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-125-53  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-102-13  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-102-94  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-125-94  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 63323-126-03  Fresenius Kabi USA, LLC  ANDA090799  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 16714-909-01  NorthStar Rx LLC  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 71288-113-10  Meitheal Pharmaceuticals Inc.  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 55390-391-50  Bedford Laboratories  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 55111-687-25  Dr. Reddy's Laboratories Limited  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 55390-391-10  Bedford Laboratories  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 16714-930-01  NorthStar Rx LLC  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
GEMCITABINE 71288-114-50  Meitheal Pharmaceuticals Inc.  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 55111-686-07  Dr. Reddy's Laboratories Limited  ANDA091365  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 25021-235-51  Sagent Pharmaceuticals  ANDA202485  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 25021-234-10  Sagent Pharmaceuticals  ANDA202485  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine 25021-235-50  Sagent Pharmaceuticals  ANDA202485  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine hydrochloride 68083-149-01  Gland Pharma Limited  ANDA204520  HUMAN PRESCRIPTION DRUG  ANDA 
gemcitabine hydrochloride 68083-148-01  Gland Pharma Limited  ANDA204520  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 67457-616-10  Mylan Institutional LLC  ANDA205242  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 67457-618-10  Mylan Institutional LLC  ANDA205242  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 67457-617-30  Mylan Institutional LLC  ANDA205242  HUMAN PRESCRIPTION DRUG  ANDA 
Gemcitabine 0143-9394-01  Hikma Pharmaceuticals USA Inc.  ANDA206617  HUMAN PRESCRIPTION DRUG  ANDA 
1-30 31-53

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