NDC 61919-378

GLYBURIDE

Glyburide

GLYBURIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Glyburide.

Product ID61919-378_2615ee96-7a3e-5cde-e054-00144ff8d46c
NDC61919-378
Product TypeHuman Prescription Drug
Proprietary NameGLYBURIDE
Generic NameGlyburide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-12-03
Marketing CategoryANDA / ANDA
Application NumberANDA090937
Labeler NameDirectRX
Substance NameGLYBURIDE
Active Ingredient Strength5 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-378-90

90 TABLET in 1 BOTTLE (61919-378-90)
Marketing Start Date2019-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-378-60 [61919037860]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA090937
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-03
Inactivation Date2020-01-31

NDC 61919-378-90 [61919037890]

Glyburide TABLET
Marketing CategoryANDA
Application NumberANDA090937
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-15

Drug Details

Active Ingredients

IngredientStrength
GLYBURIDE5 mg/1

OpenFDA Data

SPL SET ID:2615ee96-7a3d-5cde-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310537

    • 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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