GLUCOVANCE
GLUCOVANCE (Glyburide and Metformin HCl) Tablets
Approved
Approval ID
ff281ebd-29c2-4852-a8ab-c4f21abe8b7c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 23, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4609
Application NumberNDA021178
Product Classification
M
Marketing Category
C73594
G
Generic Name
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 23, 2012
FDA Product Classification
INGREDIENTS (6)
glyburideActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
metformin hydrochlorideActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT