Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Recipharm Pessac S.A.S.
Waylis Therapeutics LLC
871401927
Bora Pharmaceuticals
Waylis Therapeutics LLC
205556368
Future Pak LLC
Waylis Therapeutics LLC
087737672
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Coreg CR
Product Details
NDC Product Code
80725-388Application Number
NDA022012Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023CarvedilolActive
Code: EQT531S367Class: ACTIBQuantity: 80 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Coreg CR
Product Details
NDC Product Code
80725-383Application Number
NDA022012Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023CarvedilolActive
Code: EQT531S367Class: ACTIBQuantity: 10 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Coreg CR
Product Details
NDC Product Code
80725-387Application Number
NDA022012Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
CarvedilolActive
Code: EQT531S367Class: ACTIBQuantity: 40 mg in 1 1
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Coreg CR
Product Details
NDC Product Code
80725-385Application Number
NDA022012Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 31, 2023CarvedilolActive
Code: EQT531S367Class: ACTIBQuantity: 20 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT