NDC 69097-821

Gemfibrozil

Gemfibrozil

Gemfibrozil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Gemfibrozil.

Product ID69097-821_0d0e2af3-dead-46fa-b056-ea042d661941
NDC69097-821
Product TypeHuman Prescription Drug
Proprietary NameGemfibrozil
Generic NameGemfibrozil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-13
Marketing CategoryANDA / ANDA
Application NumberANDA077836
Labeler NameCipla USA Inc.
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 Through2021-12-31

Packaging

NDC 69097-821-03

60 TABLET in 1 BOTTLE (69097-821-03)
Marketing Start Date2016-10-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-821-12 [69097082112]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-13

NDC 69097-821-03 [69097082103]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-13

NDC 69097-821-07 [69097082107]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-13

Drug Details

Active Ingredients

IngredientStrength
GEMFIBROZIL600 mg/1

OpenFDA Data

SPL SET ID:05bfbcdc-03ab-4fba-9582-980602410ef9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310459
  • UPC Code
  • 0369097821036
  • Pharmacological Class

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

    Medicade Reported Pricing

    69097082112 GEMFIBROZIL 600 MG TABLET

    Pricing Unit: EA | Drug Type:

    69097082103 GEMFIBROZIL 600 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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