NDC 0093-8343

Glyburide

Glyburide

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

Product ID0093-8343_b3105c4c-4aac-4b00-bc1b-98cf2c07c3b5
NDC0093-8343
Product TypeHuman Prescription Drug
Proprietary NameGlyburide
Generic NameGlyburide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1995-08-30
Marketing CategoryANDA / ANDA
Application NumberANDA074388
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameGLYBURIDE
Active Ingredient Strength3 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0093-8343-01

100 TABLET in 1 BOTTLE (0093-8343-01)
Marketing Start Date1995-08-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-8343-93 [00093834393]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-30
Marketing End Date2009-08-07

NDC 0093-8343-98 [00093834398]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-30

NDC 0093-8343-05 [00093834305]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-08-30

NDC 0093-8343-50 [00093834350]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-12
Marketing End Date2013-03-12

NDC 0093-8343-01 [00093834301]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-08-30

NDC 0093-8343-19 [00093834319]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-30
Marketing End Date2009-08-07

NDC 0093-8343-10 [00093834310]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-08-30

Drug Details

Active Ingredients

IngredientStrength
GLYBURIDE2.5 mg/1

OpenFDA Data

SPL SET ID:a56f100f-0f42-4188-81ab-04644b824040
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197737
  • 310537
  • 310534
    • UPC Code
  • 0300938344017
  • 0300938342013
  • 0300938343010

    • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]

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

    NDCBrand NameGeneric Name
    0093-8034GlyburideGlyburide
    0093-8035GlyburideGlyburide
    0093-8036GlyburideGlyburide
    0093-8342GlyburideGlyburide
    0093-8343GlyburideGlyburide
    0093-8344GlyburideGlyburide
    0093-9364Glyburideglyburide
    0093-9433Glyburideglyburide
    0093-9477Glyburideglyburide
    0115-1742GlyburideGlyburide
    0115-1743GlyburideGlyburide
    0115-1744GlyburideGlyburide
    0121-0929GlyburideGlyburide
    0121-0930GlyburideGlyburide
    0121-0931GlyburideGlyburide
    0143-9918GlyburideGlyburide
    0143-9919GlyburideGlyburide
    68071-2189GlyburideGlyburide
    68071-3097GlyburideGlyburide
    68071-4142GlyburideGlyburide
    68071-4452GlyburideGlyburide
    68071-4695GlyburideGlyburide
    68071-4730GlyburideGlyburide
    68382-656glyburideglyburide
    68382-657glyburideglyburide
    68382-658glyburideglyburide
    68788-9216GlyburideGlyburide
    68788-6885GlyburideGlyburide
    68788-9917GlyburideGlyburide
    70518-0019GlyburideGlyburide
    70518-0631GlyburideGlyburide
    70518-1201GlyburideGlyburide
    70518-1121glyBURIDEglyBURIDE
    70518-1513GlyburideGlyburide
    70518-1646GlyburideGlyburide
    71209-009GlyburideGlyburide
    71209-011GlyburideGlyburide
    71335-0069GlyburideGlyburide
    71335-0150GlyburideGlyburide
    71209-010GlyburideGlyburide
    0615-4509GlyburideGlyburide
    0615-1556GlyburideGlyburide
    75834-202GLYBURIDEGLYBURIDE
    75834-204GLYBURIDEGLYBURIDE
    76333-155GlyburideGlyburide
    76333-156GlyburideGlyburide
    75834-203GLYBURIDEGLYBURIDE
    76333-154GlyburideGlyburide
    10544-232GlyburideGlyburide
    10544-300GlyburideGlyburide
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