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
NDC Product Code0009-0341
Application NumberNDA020051
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 6, 2023
Generic Nameglyburide
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
NDC Product Code0009-0352
Application NumberNDA020051
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 6, 2023
Generic Nameglyburide
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
NDC Product Code0009-3449
Application NumberNDA020051
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 6, 2023
Generic Nameglyburide
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