NDC 65841-826

glyburide and metformin hydrochloride

Glyburide And Metformin Hydrochloride

glyburide and metformin hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Glyburide; Metformin Hydrochloride.

Product ID65841-826_74ad710f-2587-4697-a053-bf02d23fadcb
NDC65841-826
Product TypeHuman Prescription Drug
Proprietary Nameglyburide and metformin hydrochloride
Generic NameGlyburide And Metformin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-04-07
Marketing CategoryANDA / ANDA
Application NumberANDA206748
Labeler NameZydus Lifesciences Limited
Substance NameGLYBURIDE; METFORMIN HYDROCHLORIDE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesBiguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65841-826-01

100 TABLET in 1 BOTTLE (65841-826-01)
Marketing Start Date2016-04-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-826-30 [65841082630]

glyburide and metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA206748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-07

NDC 65841-826-77 [65841082677]

glyburide and metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA206748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-07

NDC 65841-826-06 [65841082606]

glyburide and metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA206748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-07

NDC 65841-826-10 [65841082610]

glyburide and metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA206748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-07

NDC 65841-826-05 [65841082605]

glyburide and metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA206748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-07

NDC 65841-826-16 [65841082616]

glyburide and metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA206748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-07

NDC 65841-826-01 [65841082601]

glyburide and metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA206748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-07

Drug Details

Active Ingredients

IngredientStrength
GLYBURIDE5 mg/1

OpenFDA Data

SPL SET ID:df752bd4-e197-40a4-a01b-d48ba2c10516
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861753
  • 861748
  • 861743

    • 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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