NDC Code(s) : 68788-6889-3, 68788-6889-6, 68788-6889-9, 68788-6889-1, 68788-6889-8
Packager : Preferred Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Benazepril HydrochlorideBenazepril Hydrochloride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-6889(NDC:43547-335)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE(UNII: N1SN99T69T)
(BENAZEPRILAT - UNII:JRM708L703) 		BENAZEPRIL HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code S;341
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-6889-330 in 1 BOTTLE Type 0: Not a Combination Product02/06/2017
2NDC:68788-6889-660 in 1 BOTTLE Type 0: Not a Combination Product02/06/2017
3NDC:68788-6889-990 in 1 BOTTLE Type 0: Not a Combination Product02/06/2017
4NDC:68788-6889-1100 in 1 BOTTLE Type 0: Not a Combination Product02/06/2017
5NDC:68788-6889-8120 in 1 BOTTLE Type 0: Not a Combination Product02/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076118 02/06/2017

LABELER - Preferred Pharmaceuticals Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-6889)

PRINCIPAL DISPLAY PANEL

NDC 68788-  6889   Rx only

Benazepril Hydrochloride Tablets USP

5 mg

SolcoHealthcare U.S.

Repackaged By: Preferred Pharmaceuticals Inc.

Benazepril Hydrochloride Tablet 5mg