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COREGCR

These highlights do not include all the information needed to use COREG CR safely and effectively. See full prescribing information for COREG CR. COREG CR (carvedilol phosphate) Extended-release CapsulesInitial U.S. Approval: 1995

Approved
Approval ID

bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 8, 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 phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-0106
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2010
FDA Product Classification

INGREDIENTS (6)

CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CARVEDILOL PHOSPHATEActive
Quantity: 20 mg in 1 1
Code: EQT531S367
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

carvedilol phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-6019
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2010
FDA Product Classification

INGREDIENTS (6)

CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARVEDILOL PHOSPHATEActive
Quantity: 10 mg in 1 1
Code: EQT531S367
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

carvedilol phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5869
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2010
FDA Product Classification

INGREDIENTS (6)

HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CARVEDILOL PHOSPHATEActive
Quantity: 40 mg in 1 1
Code: EQT531S367
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

carvedilol phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5771
Application NumberNDA022012
Product Classification
M
Marketing Category
C73594
G
Generic Name
carvedilol phosphate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2010
FDA Product Classification

INGREDIENTS (6)

HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CARVEDILOL PHOSPHATEActive
Quantity: 80 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

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COREGCR - FDA Drug Approval Details