NDC 0115-1650

Glyburide and Metformin Hydrochloride

Glyburide And Metformin Hydrochloride

Glyburide and Metformin Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Glyburide; Metformin Hydrochloride.

Product ID0115-1650_5531ac0a-ef76-41f1-9845-f3d1f6bd82dd
NDC0115-1650
Product TypeHuman Prescription Drug
Proprietary NameGlyburide and Metformin Hydrochloride
Generic NameGlyburide And Metformin Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-08-03
Marketing CategoryANDA / ANDA
Application NumberANDA076716
Labeler NameImpax Generics
Substance NameGLYBURIDE; METFORMIN HYDROCHLORIDE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0115-1650-01

100 TABLET, FILM COATED in 1 BOTTLE (0115-1650-01)
Marketing Start Date2016-08-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1650-01 [00115165001]

Glyburide and Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076716
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-03
Marketing End Date2019-01-31

NDC 0115-1650-02 [00115165002]

Glyburide and Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076716
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-03
Marketing End Date2018-10-31

Drug Details

Active Ingredients

IngredientStrength
GLYBURIDE5 mg/1

OpenFDA Data

SPL SET ID:480d45ea-6387-40b7-b41c-31deb9949e63
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861753
  • 861748
  • 861743
    • UPC Code
  • 0301151649019
  • 0301151648012

    • Pharmacological Class

    • Sulfonylurea [EPC]
    • Sulfonylurea Compounds [CS]
    • Biguanide [EPC]
    • Biguanides [CS]

    NDC Crossover Matching brand name "Glyburide and Metformin Hydrochloride" or generic name "Glyburide And Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    0115-1648Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    0115-1649Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    0115-1650Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    0228-2751Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    0228-2752Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    0228-2753Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    43063-397Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    45865-710Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    50090-0887Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    50090-0888Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    50090-2030Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    50090-2031Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    50268-355Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    50268-356Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    50268-357Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    50436-0024Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    51655-942Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    55111-695GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE AND METFORMIN HYDROCHLORIDE
    55111-696GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE AND METFORMIN HYDROCHLORIDE
    55111-697GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE AND METFORMIN HYDROCHLORIDE
    55700-395Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    55700-469glyburide and metformin hydrochlorideglyburide and metformin hydrochloride
    55700-612Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    57237-023Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    57237-024Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    57237-025Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68071-1967Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68071-1836Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68071-4093Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68071-4109Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68071-4444Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68071-4453Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68071-4718Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68071-4828Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68382-653glyburide and metformin hydrochlorideglyburide and metformin hydrochloride
    68382-655glyburide and metformin hydrochlorideglyburide and metformin hydrochloride
    68382-654glyburide and metformin hydrochlorideglyburide and metformin hydrochloride
    68788-6915glyburide and metformin hydrochlorideglyburide and metformin hydrochloride
    68788-9128Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68788-6426Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68788-9728Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68788-9966Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68788-7180Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    68788-9716Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    71335-0127glyburide and metformin hydrochlorideglyburide and metformin hydrochloride
    71335-0360Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    71335-0980Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    71335-0967Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
    71335-0114glyburide and metformin hydrochlorideglyburide and metformin hydrochloride
    71335-0179Glyburide and Metformin HydrochlorideGlyburide and Metformin Hydrochloride
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