Coreg
These highlights do not include all the information needed to use COREG safely and effectively. See full prescribing information for COREG. COREG (carvedilol) tabletsInitial U.S. Approval: 1995
Approved
Approval ID
fdb12700-116b-4203-8d74-9a94b9401fe6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4395
Application NumberNDA020297
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2010
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARVEDILOLActive
Quantity: 25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4396
Application NumberNDA020297
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2010
FDA Product Classification
INGREDIENTS (11)
CARVEDILOLActive
Quantity: 12.5 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4421
Application NumberNDA020297
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2010
FDA Product Classification
INGREDIENTS (11)
CARVEDILOLActive
Quantity: 3.125 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4424
Application NumberNDA020297
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2010
FDA Product Classification
INGREDIENTS (11)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CARVEDILOLActive
Quantity: 6.25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT