Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Beximco Pharmaceuticals USA Inc
731557430
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Beximco Pharmaceuticals Ltd
Bayshore Pharmaceuticals LLC
Beximco Pharmaceuticals USA Inc
731579053
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carvedilol
Product Details
NDC Product Code
76385-113Application Number
ANDA078384Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 26, 2019CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
CarvedilolActive
Code: 0K47UL67F2Class: ACTIBQuantity: 25 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Carvedilol
Product Details
NDC Product Code
76385-110Application Number
ANDA078384Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 26, 2019SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
CarvedilolActive
Code: 0K47UL67F2Class: ACTIBQuantity: 3.125 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Carvedilol
Product Details
NDC Product Code
76385-112Application Number
ANDA078384Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 26, 2019CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CarvedilolActive
Code: 0K47UL67F2Class: ACTIBQuantity: 12.5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
Carvedilol
Product Details
NDC Product Code
76385-111Application Number
ANDA078384Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 26, 2019POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
CarvedilolActive
Code: 0K47UL67F2Class: ACTIBQuantity: 6.25 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT