Glipizide
These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE extended-release tablets, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
0ffe361a-c99b-4f68-a7e2-a67a71c0c496
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2018
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glipizide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-280
Application NumberANDA204720
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2018
FDA Product Classification
INGREDIENTS (14)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GLIPIZIDEActive
Quantity: 5 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Glipizide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-281
Application NumberANDA204720
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2018
FDA Product Classification
INGREDIENTS (14)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLIPIZIDEActive
Quantity: 10 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Glipizide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-279
Application NumberANDA204720
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2018
FDA Product Classification
INGREDIENTS (17)
GLIPIZIDEActive
Quantity: 2.5 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT