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 useInitial U.S. Approval: 1995
Approved
Approval ID
eb892787-edd0-4ab6-aef2-2d0216384395
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Quallent Pharmaceuticals Health LLC
DUNS: 815564528
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 Code82009-126
Application NumberANDA077614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (10)
CARVEDILOLActive
Quantity: 6.25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-125
Application NumberANDA077614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (10)
CARVEDILOLActive
Quantity: 3.125 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-127
Application NumberANDA077614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CARVEDILOLActive
Quantity: 12.5 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82009-128
Application NumberANDA077614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CARVEDILOLActive
Quantity: 25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT