NDC 0093-0670

Gemfibrozil

Gemfibrozil

Gemfibrozil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Gemfibrozil.

Product ID0093-0670_c1a5dc78-eab0-4d04-8dae-ac59a1f97ff9
NDC0093-0670
Product TypeHuman Prescription Drug
Proprietary NameGemfibrozil
Generic NameGemfibrozil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1993-11-24
Marketing End Date2020-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA074256
Labeler NameTeva Pharmaceuticals 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

Packaging

NDC 0093-0670-05

500 TABLET, FILM COATED in 1 BOTTLE (0093-0670-05)
Marketing Start Date1993-11-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-0670-06 [00093067006]

Gemfibrozil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074256
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1993-11-24
Marketing End Date2019-01-31

NDC 0093-0670-93 [00093067093]

Gemfibrozil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074256
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-05
Marketing End Date2013-11-30

NDC 0093-0670-05 [00093067005]

Gemfibrozil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074256
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1993-11-24
Marketing End Date2020-03-31

NDC 0093-0670-19 [00093067019]

Gemfibrozil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074256
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-26
Marketing End Date2019-10-18

NDC 0093-0670-10 [00093067010]

Gemfibrozil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074256
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-10-29
Marketing End Date2014-12-22

Drug Details

Active Ingredients

IngredientStrength
GEMFIBROZIL600 mg/1

OpenFDA Data

SPL SET ID:beade464-5f49-42c8-8373-a1406ccbacd7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310459
    • UPC Code
  • 0300930670053

    • 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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