NDC 10544-580

Glyburide-Metformin Hydrochloride

Glyburide-metformin Hydrochloride

Glyburide-Metformin Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Glyburide; Metformin Hydrochloride.

Product ID10544-580_0f5e4bb2-193d-3a95-e054-00144ff8d46c
NDC10544-580
Product TypeHuman Prescription Drug
Proprietary NameGlyburide-Metformin Hydrochloride
Generic NameGlyburide-metformin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA079009
Labeler NameBlenheim Pharmacal, Inc.
Substance NameGLYBURIDE; METFORMIN HYDROCHLORIDE
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-580-90

90 TABLET in 1 BOTTLE (10544-580-90)
Marketing Start Date2013-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-580-90 [10544058090]

Glyburide-Metformin Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-20
Inactivation Date2020-01-31

NDC 10544-580-30 [10544058030]

Glyburide-Metformin Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079009
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GLYBURIDE2.5 mg/1

OpenFDA Data

SPL SET ID:0f530fcd-0ac0-3885-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861753
  • 861748
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Glyburide-Metformin Hydrochloride" or generic name "Glyburide-metformin Hydrochloride"

    NDCBrand NameGeneric Name
    10544-579Glyburide-Metformin HydrochlorideGlyburide-Metformin Hydrochloride
    10544-580Glyburide-Metformin HydrochlorideGlyburide-Metformin Hydrochloride
    23155-233glyburide-metformin hydrochlorideglyburide-metformin hydrochloride
    23155-234glyburide-metformin hydrochlorideglyburide-metformin hydrochloride
    23155-235glyburide-metformin hydrochlorideglyburide-metformin hydrochloride

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