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Carvedilol Phosphate

These highlights do not include all the information needed to use Carvedilol Phosphate extended-release capsules safely and effectively. See full prescribing information for Carvedilol Phosphate extended-release capsules. Carvedilol Phosphate extended-release capsules for oral use Initial U.S. Approval: 1995

Approved
Approval ID

e434f355-6f29-4a98-9702-9fc65de2aa26

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 25, 2022

Manufacturers
FDA

Woodward Pharma Services LLC

DUNS: 080406260

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 Code69784-714
Application NumberNDA022012
Product Classification
M
Marketing Category
C73605
G
Generic Name
Carvedilol Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2022
FDA Product Classification

INGREDIENTS (6)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
carvedilol phosphateActive
Quantity: 20 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT

Carvedilol Phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69784-716
Application NumberNDA022012
Product Classification
M
Marketing Category
C73605
G
Generic Name
Carvedilol Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2022
FDA Product Classification

INGREDIENTS (6)

carvedilol phosphateActive
Quantity: 80 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT

Carvedilol Phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69784-713
Application NumberNDA022012
Product Classification
M
Marketing Category
C73605
G
Generic Name
Carvedilol Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2022
FDA Product Classification

INGREDIENTS (6)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
carvedilol phosphateActive
Quantity: 10 mg in 1 1
Code: EQT531S367
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT

Carvedilol Phosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69784-715
Application NumberNDA022012
Product Classification
M
Marketing Category
C73605
G
Generic Name
Carvedilol Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2022
FDA Product Classification

INGREDIENTS (6)

CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
carvedilol phosphateActive
Quantity: 40 mg in 1 1
Code: EQT531S367
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT

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Carvedilol Phosphate - FDA Drug Approval Details