NDC 68382-553

Gemfibrozil

Gemfibrozil

Gemfibrozil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Gemfibrozil.

Product ID68382-553_02ea511e-b0ab-4c32-966f-0fd3343ffb68
NDC68382-553
Product TypeHuman Prescription Drug
Proprietary NameGemfibrozil
Generic NameGemfibrozil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA204189
Labeler NameZydus 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
Listing Certified Through2020-12-31

Packaging

NDC 68382-553-01

100 TABLET in 1 BOTTLE (68382-553-01)
Marketing Start Date2019-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-553-05 [68382055305]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

NDC 68382-553-10 [68382055310]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

NDC 68382-553-16 [68382055316]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

NDC 68382-553-30 [68382055330]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

NDC 68382-553-01 [68382055301]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

NDC 68382-553-06 [68382055306]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

NDC 68382-553-14 [68382055314]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

Drug Details

Active Ingredients

IngredientStrength
GEMFIBROZIL600 mg/1

OpenFDA Data

SPL SET ID:556945e8-4100-4538-bcba-af5b2f13a7e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310459
    • UPC Code
  • 0368382553065

    • 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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