Carvedilol
These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
f5969d18-46c7-4f35-9668-2fd4f6bbeb17
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 3
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 Code50090-2079
Application NumberANDA078332
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2023
FDA Product Classification
INGREDIENTS (11)
CARVEDILOLActive
Quantity: 12.5 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1069
Application NumberANDA078332
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CARVEDILOLActive
Quantity: 25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1064
Application NumberANDA078332
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2023
FDA Product Classification
INGREDIENTS (11)
CARVEDILOLActive
Quantity: 6.25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT