Glyburide and Metformin
GLYBURIDE and METFORMIN HYDROCHLORIDE TABLETS USPRx only571057115712
Approved
Approval ID
a5d618f3-2699-44a2-b60a-a2205c434be5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glyburide and Metformin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5243
Application NumberANDA076345
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide and Metformin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2011
FDA Product Classification
INGREDIENTS (13)
GlyburideActive
Quantity: 5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Metformin HydrochlorideActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Glyburide and Metformin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5148
Application NumberANDA076345
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide and Metformin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2011
FDA Product Classification
INGREDIENTS (13)
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
GlyburideActive
Quantity: 2.5 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
Metformin HydrochlorideActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Glyburide and Metformin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5185
Application NumberANDA076345
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glyburide and Metformin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2011
FDA Product Classification
INGREDIENTS (13)
Metformin HydrochlorideActive
Quantity: 250 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GlyburideActive
Quantity: 1.25 mg in 1 1
Code: SX6K58TVWC
Classification: ACTIB
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT