Glynase
Glynase PresTab (glyBURIDE) tablets 1.5 mg, 3 mg, and 6 mg
Approved
Approval ID
a7fce80a-2f13-43cc-8e1c-561f7d3ec3d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Pharmacia & Upjohn Company LLC
DUNS: 618054084
Products 3
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 Code0009-0341
Application NumberNDA020051
Product Classification
M
Marketing Category
C73594
G
Generic Name
glyburide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (5)
GLYBURIDEActive
Quantity: 1.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
glyburide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-0352
Application NumberNDA020051
Product Classification
M
Marketing Category
C73594
G
Generic Name
glyburide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (7)
GLYBURIDEActive
Quantity: 3 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
glyburide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-3449
Application NumberNDA020051
Product Classification
M
Marketing Category
C73594
G
Generic Name
glyburide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (7)
GLYBURIDEActive
Quantity: 6 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT