NDC Code(s) : 72888-034-30, 72888-034-01, 72888-034-05, 72888-034-00, 72888-035-30, 72888-035-01, 72888-035-05, 72888-035-00, 72888-036-30, 72888-036-01, 72888-036-05, 72888-036-00, 72888-037-30, 72888-037-01, 72888-037-05, 72888-037-00
Packager : Advagen Pharma Ltd

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:72888-034
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYETHYL CELLULOSE, UNSPECIFIED(UNII: T4V6TWG28D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 800(UNII: UH6KR4953D)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white to off white) Score no score
Shape OVAL Size 6 mm
Flavor Imprint Code UpArrowhead;55
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72888-034-3030 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
2NDC:72888-034-01100 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
3NDC:72888-034-05500 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
4NDC:72888-034-001000 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078165 07/29/2021
CARVEDILOLCARVEDILOL TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL6.25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYETHYL CELLULOSE, UNSPECIFIED(UNII: T4V6TWG28D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 800(UNII: UH6KR4953D)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white to off white) Score no score
Shape OVAL Size 8 mm
Flavor Imprint Code UpArrowhead;56
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72888-035-3030 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
2NDC:72888-035-01100 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
3NDC:72888-035-05500 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
4NDC:72888-035-001000 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078165 07/29/2021
CARVEDILOLCARVEDILOL TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-036
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYETHYL CELLULOSE, UNSPECIFIED(UNII: T4V6TWG28D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 800(UNII: UH6KR4953D)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white to off white) Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code UpArrowhead;57
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72888-036-3030 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
2NDC:72888-036-01100 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
3NDC:72888-036-05500 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
4NDC:72888-036-001000 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078165 07/29/2021
CARVEDILOLCARVEDILOL TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-037
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYETHYL CELLULOSE, UNSPECIFIED(UNII: T4V6TWG28D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 800(UNII: UH6KR4953D)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white to off white) Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code UpArrowhead;59
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72888-037-3030 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
2NDC:72888-037-01100 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
3NDC:72888-037-05500 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
4NDC:72888-037-001000 in 1 BOTTLE Type 0: Not a Combination Product29/07/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078165 07/29/2021

LABELER - Advagen Pharma Ltd(051627256)

Establishment
Name Address ID/FEI Business Operations
Rubicon Research Private Limited 677604197 manufacture(72888-034, 72888-035, 72888-036, 72888-037), analysis(72888-034, 72888-035, 72888-036, 72888-037), pack(72888-034, 72888-035, 72888-036, 72888-037)

PRINCIPAL DISPLAY PANEL

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-01 - 100 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-05 - 500 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-00 - 1000 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 6.25 mg - NDC 72888-035-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP,6.25 mg - NDC 72888-035-01 - 100 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 6.25 mg - NDC 72888-035-05 - 500 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 6.25 mg - NDC 72888-035-00 - 1000 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 12.5 mg - NDC 72888-036-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 12.5 mg - NDC 72888-036-01 - 100 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 12.5 mg - NDC 72888-036-05 - 500 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 12.5 mg - NDC 72888-036-00 - 1000 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 25 mg - NDC 72888-037-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 25 mg - NDC 72888-037-01 - 100 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 25 mg - NDC 72888-037-05 - 500 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label

Carvedilol Tablets USP, 25 mg - NDC 72888-037-00 - 1000 Tablets Container Label

Carvedilol Tablets USP, 3.125 mg - NDC 72888-034-30 - 30 Tablets Container Label