NDC 68788-8177-6
API & Excipient Details

Carvedilol marketed by Preferred Pharmaceuticals Inc. under NDC Code 68788-8177-6

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CARVEDILOL(UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)	CARVEDILOL	6.25 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68788-8177-3	30 in 1 BOTTLE Type 0: Not a Combination Product	28/04/2022
2	NDC:68788-8177-6	60 in 1 BOTTLE Type 0: Not a Combination Product	28/04/2022
3	NDC:68788-8177-9	90 in 1 BOTTLE Type 0: Not a Combination Product	28/04/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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