Benazepril Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benazepril Hydrochloride Tablets, USP 40mg

NDC: 10544-561-30

Container Label
(click image for full-size original)
BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-561(NDC:63304-340)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENAZEPRIL HYDROCHLORIDE (BENAZEPRILAT) BENAZEPRIL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
STARCH, PREGELATINIZED CORN
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 344
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-561-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10544-561-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076118 11/13/2013
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-561)

Revised: 10/2015 Blenheim Pharmacal, Inc.

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