NDC 75834-202

GLYBURIDE

Glyburide

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

Product ID75834-202_757b12d9-8efb-49ca-b8f7-7884535ca011
NDC75834-202
Product TypeHuman Prescription Drug
Proprietary NameGLYBURIDE
Generic NameGlyburide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-01-25
Marketing CategoryANDA / ANDA
Application NumberANDA203379
Labeler NameNivagen Pharmaceuticals, Inc.
Substance NameGLYBURIDE
Active Ingredient Strength1 mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 75834-202-00

1000 TABLET in 1 BOTTLE (75834-202-00)
Marketing Start Date2019-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75834-202-00 [75834020200]

GLYBURIDE TABLET
Marketing CategoryANDA
Application NumberANDA203379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-25

NDC 75834-202-01 [75834020201]

GLYBURIDE TABLET
Marketing CategoryANDA
Application NumberANDA203379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-25

Drug Details

Active Ingredients

IngredientStrength
GLYBURIDE1.25 mg/1

OpenFDA Data

SPL SET ID:43c6f68b-5747-47c6-9538-51ef8c611db4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197737
  • 310537
  • 310534
  • UPC Code
  • 0375834202013
  • 0375834203010
  • 0375834204017
  • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]
    • 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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