stration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL PHOSPHATE 20 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONES (UNII: FZ989GH94E)
PRODUCT CHARACTERISTICS
Color WHITE, YELLOW Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code GSK;COREG;CR;20;mg
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0007-3371-13 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2007
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022012 02/06/2007
COREG CR
carvedilol phosphate capsule, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-3372
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL PHOSPHATE 40 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONES (UNII: FZ989GH94E)
PRODUCT CHARACTERISTICS
Color GREEN, YELLOW Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code GSK;COREG;CR;40;mg
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0007-3372-13 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2007
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022012 02/14/2007
COREG CR
carvedilol phosphate capsule, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0007-3373
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
CARVEDILOL PHOSPHATE (UNII: EQT531S367) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL PHOSPHATE 80 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONES (UNII: FZ989GH94E)
PRODUCT CHARACTERISTICS
Color&n |
