NDC 68071-2189

Glyburide

Glyburide

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

Product ID68071-2189_4b6b2ce1-e34a-3921-e054-00144ff8d46c
NDC68071-2189
Product TypeHuman Prescription Drug
Proprietary NameGlyburide
Generic NameGlyburide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1995-08-30
Marketing CategoryANDA / ANDA
Application NumberANDA074388
Labeler NameNuCare Pharmaceuticals, Inc.
Substance NameGLYBURIDE
Active Ingredient Strength3 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-2189-9

90 TABLET in 1 BOTTLE (68071-2189-9)
Marketing Start Date2017-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-2189-9 [68071218909]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-23
Marketing End Date2019-12-31

NDC 68071-2189-3 [68071218903]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-23
Marketing End Date2019-12-31

NDC 68071-2189-6 [68071218906]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA074388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-23
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
GLYBURIDE2.5 mg/1

OpenFDA Data

SPL SET ID:4b6b2ce1-e349-3921-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310534
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.