Carvedilol
These highlights do not include all the information needed to use CARVEDILOL TABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLETS, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 1995
Approved
Approval ID
33dfcf29-19d6-46ba-b8ed-d59d2226ad07
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bayshore Pharmaceuticals LLC
DUNS: 968737416
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 Code76385-113
Application NumberANDA078384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2019
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CARVEDILOLActive
Quantity: 25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-110
Application NumberANDA078384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2019
FDA Product Classification
INGREDIENTS (11)
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CARVEDILOLActive
Quantity: 3.125 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-112
Application NumberANDA078384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2019
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARVEDILOLActive
Quantity: 12.5 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76385-111
Application NumberANDA078384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2019
FDA Product Classification
INGREDIENTS (11)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CARVEDILOLActive
Quantity: 6.25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT