NDC 71209-008

Gemfibrozil

Gemfibrozil

Gemfibrozil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cadila Pharmaceuticals Limited. The primary component is Gemfibrozil.

Product ID71209-008_14a70490-45bf-4ba4-9d26-1b9537730729
NDC71209-008
Product TypeHuman Prescription Drug
Proprietary NameGemfibrozil
Generic NameGemfibrozil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-06-17
Marketing CategoryANDA / ANDA
Application NumberANDA203266
Labeler NameCadila Pharmaceuticals Limited
Substance NameGEMFIBROZIL
Active Ingredient Strength600 mg/1
Pharm ClassesPeroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71209-008-03

60 TABLET in 1 BOTTLE (71209-008-03)
Marketing Start Date2018-10-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71209-008-10 [71209000810]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA203266
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-17

NDC 71209-008-03 [71209000803]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA203266
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-17

NDC 71209-008-08 [71209000808]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA203266
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-17

Drug Details

Active Ingredients

IngredientStrength
GEMFIBROZIL600 mg/1

OpenFDA Data

SPL SET ID:0b50849a-66b6-4e8f-9f45-5425a875d366
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310459
  • UPC Code
  • 0371209008105
  • 0371209008037
  • 0371209008082
  • Pharmacological Class

    • Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
    • PPAR alpha [CS]
    • Peroxisome Proliferator Receptor alpha Agonist [EPC]

    NDC Crossover Matching brand name "Gemfibrozil" or generic name "Gemfibrozil"

    NDCBrand NameGeneric Name
    0093-0670GemfibrozilGemfibrozil
    0143-9130GemfibrozilGemfibrozil
    0143-9707GemfibrozilGemfibrozil
    0179-0221GemfibrozilGemfibrozil
    0615-3559GemfibrozilGemfibrozil
    0615-8354GemfibrozilGemfibrozil
    10544-569GemfibrozilGemfibrozil
    16571-784GemfibrozilGemfibrozil
    16714-101Gemfibrozilgemfibrozil
    21695-732GemfibrozilGemfibrozil
    24658-260GemfibrozilGemfibrozil
    31722-128GEMFIBROZILGemfibrozil
    31722-225GemfibrozilGemfibrozil
    33261-146GemfibrozilGemfibrozil
    42806-260GEMFIBROZILGEMFIBROZIL
    43063-745GemfibrozilGemfibrozil
    43063-921GEMFIBROZILGEMFIBROZIL
    43353-090GemfibrozilGemfibrozil
    43353-772GemfibrozilGemfibrozil
    43602-452GEMFIBROZILGemfibrozil
    50090-0458GemfibrozilGemfibrozil
    50090-2450GemfibrozilGemfibrozil
    50090-2902GemfibrozilGemfibrozil
    50090-5808GEMFIBROZILGemfibrozil
    50268-350GemfibrozilGemfibrozil
    68071-1733GemfibrozilGemfibrozil
    68071-4053GEMFIBROZILGEMFIBROZIL
    68071-4011GEMFIBROZILGEMFIBROZIL
    68071-4631GemfibrozilGemfibrozil
    68071-4421GemfibrozilGemfibrozil
    68151-2893GemfibrozilGemfibrozil
    68382-553GemfibrozilGemfibrozil
    68788-6447GemfibrozilGemfibrozil
    68788-7011GEMFIBROZILGEMFIBROZIL
    68788-9149GemfibrozilGemfibrozil
    69097-821GemfibrozilGemfibrozil
    70518-1563GemfibrozilGemfibrozil
    70518-1301GemfibrozilGemfibrozil
    70771-1431GemfibrozilGemfibrozil
    71205-169GemfibrozilGemfibrozil
    71209-008GemfibrozilGemfibrozil
    71335-0051GEMFIBROZILGEMFIBROZIL
    71335-0971GemfibrozilGemfibrozil
    71335-0899GemfibrozilGemfibrozil
    71335-0515GemfibrozilGemfibrozil
    71610-200GemfibrozilGemfibrozil
    71610-107GemfibrozilGemfibrozil
    75834-131GemfibrozilGemfibrozil
    76282-225GemfibrozilGemfibrozil
    50436-6540GemfibrozilGemfibrozil

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