NDC Code(s) : 71335-2026-1, 71335-2026-2, 71335-2026-3, 71335-2026-4, 71335-2026-5, 71335-2026-6, 71335-2026-7
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:71335-2026(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:71335-2026-130 in 1 BOTTLE Type 0: Not a Combination Product02/10/2022
2NDC:71335-2026-260 in 1 BOTTLE Type 0: Not a Combination Product02/10/2022
3NDC:71335-2026-3100 in 1 BOTTLE Type 0: Not a Combination Product02/10/2022
4NDC:71335-2026-490 in 1 BOTTLE Type 0: Not a Combination Product02/10/2022
5NDC:71335-2026-5120 in 1 BOTTLE Type 0: Not a Combination Product02/10/2022
6NDC:71335-2026-6180 in 1 BOTTLE Type 0: Not a Combination Product02/10/2022
7NDC:71335-2026-710 in 1 BOTTLE Type 0: Not a Combination Product02/10/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078165 07/29/2021

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-2026), RELABEL(71335-2026)

PRINCIPAL DISPLAY PANEL

Carvedilol 12.5mg tab

Label