Glyburide
Glyburide Tablets USP(nonmicronized)1.25, 2.5 and 5 mgRx only
Approved
Approval ID
60cc988d-4175-4d7b-9021-299c46602a4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glyburide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-468
Application NumberANDA076257
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2010
FDA Product Classification
INGREDIENTS (8)
GLYBURIDEActive
Quantity: 5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Glyburide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-467
Application NumberANDA076257
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2010
FDA Product Classification
INGREDIENTS (7)
GLYBURIDEActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT