NDC 50090-2902

Gemfibrozil

Gemfibrozil

Gemfibrozil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Gemfibrozil.

Product ID50090-2902_42fe5ff7-a0d8-42f9-8079-c3a4fb0af124
NDC50090-2902
Product TypeHuman Prescription Drug
Proprietary NameGemfibrozil
Generic NameGemfibrozil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-13
Marketing CategoryANDA / ANDA
Application NumberANDA077836
Labeler NameA-S Medication Solutions
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 Through2022-12-31

Packaging

NDC 50090-2902-0

60 TABLET in 1 BOTTLE (50090-2902-0)
Marketing Start Date2017-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-2902-4 [50090290204]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-04
Marketing End Date2018-10-31

NDC 50090-2902-3 [50090290203]

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

NDC 50090-2902-0 [50090290200]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-04
Marketing End Date2018-10-31

NDC 50090-2902-2 [50090290202]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-04
Marketing End Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
GEMFIBROZIL600 mg/1

OpenFDA Data

SPL SET ID:d36ba323-f97f-4da8-9b98-ccdf3ac8d0df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310459
  • 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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