Carvedilol
CARVEDILOL TABLETS
Approved
Approval ID
29082d8c-bbde-4620-924f-02dcf1764919
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code65841-618
Application NumberANDA077614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (10)
CARVEDILOLActive
Quantity: 12.5 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-616
Application NumberANDA077614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARVEDILOLActive
Quantity: 3.125 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-617
Application NumberANDA077614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (10)
CARVEDILOLActive
Quantity: 6.25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65841-619
Application NumberANDA077614
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (10)
CARVEDILOLActive
Quantity: 25 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT