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
7a7d3ca1-05b0-4c7e-aefa-492cc441585d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2021
Manufacturers
FDA
Advagen Pharma Ltd
DUNS: 051627256
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 Code72888-034
Application NumberANDA078165
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARVEDILOL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2021
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
POLYETHYLENE GLYCOL 800Inactive
Code: UH6KR4953D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARVEDILOLActive
Quantity: 3.125 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
CARVEDILOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-036
Application NumberANDA078165
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARVEDILOL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2021
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARVEDILOLActive
Quantity: 12.5 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
POLYETHYLENE GLYCOL 800Inactive
Code: UH6KR4953D
Classification: IACT
CARVEDILOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-035
Application NumberANDA078165
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARVEDILOL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2021
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 800Inactive
Code: UH6KR4953D
Classification: IACT
CARVEDILOLActive
Quantity: 6.25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARVEDILOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-037
Application NumberANDA078165
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARVEDILOL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2021
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 800Inactive
Code: UH6KR4953D
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARVEDILOLActive
Quantity: 25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB