NDC Code(s) : 68788-8177-3, 68788-8177-6, 68788-8177-9
Packager : Preferred Pharmaceuticals Inc.

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:68788-8177(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:68788-8177-330 in 1 BOTTLE Type 0: Not a Combination Product28/04/2022
2NDC:68788-8177-660 in 1 BOTTLE Type 0: Not a Combination Product28/04/2022
3NDC:68788-8177-990 in 1 BOTTLE Type 0: Not a Combination Product28/04/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078165 04/28/2022

LABELER - Preferred Pharmaceuticals Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-8177)

PRINCIPAL DISPLAY PANEL

Carvedilol Tablets USP,6.25 mg - NDC 68788-8177

Carvedilol Tablets 6.25mg