NDC Code(s) : 71335-1128-1, 71335-1128-2, 71335-1128-3, 71335-1128-4, 71335-1128-5, 71335-1128-6, 71335-1463-1, 71335-1463-2, 71335-1463-3, 71335-1463-4, 71335-1463-5, 71335-1463-6, 71335-1533-1, 71335-1533-2, 71335-1533-3, 71335-1533-4, 71335-1533-5, 71335-1533-6
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CarvedilolCarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1128(NDC:68462-162)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL3.125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 5 mm
Flavor Imprint Code G
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71335-1128-130 in 1 BOTTLE Type 0: Not a Combination Product03/12/2019
2NDC:71335-1128-2100 in 1 BOTTLE Type 0: Not a Combination Product03/12/2019
3NDC:71335-1128-3180 in 1 BOTTLE Type 0: Not a Combination Product03/12/2019
4NDC:71335-1128-460 in 1 BOTTLE Type 0: Not a Combination Product03/12/2019
5NDC:71335-1128-590 in 1 BOTTLE Type 0: Not a Combination Product03/12/2019
6NDC:71335-1128-6120 in 1 BOTTLE Type 0: Not a Combination Product03/12/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CarvedilolCarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1463(NDC:68462-165)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code G41;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71335-1463-1100 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
2NDC:71335-1463-230 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
3NDC:71335-1463-390 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
4NDC:71335-1463-460 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
5NDC:71335-1463-5120 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
6NDC:71335-1463-6180 in 1 BOTTLE Type 0: Not a Combination Product09/05/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007
CarvedilolCarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1533(NDC:68462-164)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 10 mm
Flavor Imprint Code G;164
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71335-1533-130 in 1 BOTTLE Type 0: Not a Combination Product08/10/2011
2NDC:71335-1533-260 in 1 BOTTLE Type 0: Not a Combination Product08/10/2011
3NDC:71335-1533-3100 in 1 BOTTLE Type 0: Not a Combination Product08/10/2011
4NDC:71335-1533-490 in 1 BOTTLE Type 0: Not a Combination Product08/10/2011
5NDC:71335-1533-5120 in 1 BOTTLE Type 0: Not a Combination Product08/10/2011
6NDC:71335-1533-6180 in 1 BOTTLE Type 0: Not a Combination Product08/10/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078251 09/05/2007

LABELER - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-1463, 71335-1128, 71335-1533), RELABEL(71335-1128, 71335-1463, 71335-1533)

PRINCIPAL DISPLAY PANEL

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