Glyburide and Metformin Hydrochloride
These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
7010b662-8b34-49ce-8e5b-73dee0821a60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
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 Code65862-081
Application NumberANDA077870
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide and Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2022
FDA Product Classification
INGREDIENTS (13)
GLYBURIDEActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Glyburide and Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-082
Application NumberANDA077870
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide and Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2022
FDA Product Classification
INGREDIENTS (13)
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
GLYBURIDEActive
Quantity: 5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Glyburide and Metformin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-080
Application NumberANDA077870
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide and Metformin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2022
FDA Product Classification
INGREDIENTS (13)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
GLYBURIDEActive
Quantity: 1.25 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT