Benazepril Hydrochloride (Page 6 of 6)

For Hypertensive Patients with Renal Impairment

For patients with a creatinine clearance <30 mL/min/1.73 m2 (serum creatinine >3 mg/dL), the recommended initial dose is 5 mg benazepril hydrochloride once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 40 mg (see WARNINGS).

HOW SUPPLIED

Benazepril Hydrochloride Tablets are available as:

5 mg: yellow-orange, round, biconvex, film coated tablets, debossed “E” over “5” on one side and plain on the other.

10 mg: orange, round, biconvex, film coated tablets, debossed “E” over “53” on one side and plain on the other.

20 mg: pink, round, biconvex, film coated tablets, debossed “E” over “82” on one side and plain on the other.

40 mg: red, round, biconvex, film coated tablets, debossed “E” over “48” on one side and plain on the other.

Benazepril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg, packaged with a desiccant, are available in bottles of 90, 100 and 500 tablets.

Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. Protect from moisture.

Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Sandoz Inc.

Princeton, NJ 08540


Repackaged by:

Rebel Distributors Corp.

Thousand Oaks, CA 91320

OS8016

Rev. 01/09

MF0005REV01/09

MG #17815

Principal Display Panel

Benazepril HCl 10mg
(click image for full-size original)

Principal Display Panel

Benazepril HCl 5mg
(click image for full-size original)

BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-612(NDC:0185-0505)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benazepril hydrochloride (benazepril) benazepril hydrochloride 5 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
crospovidone
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYDROGENATED CASTOR OIL
hypromellose
lactose monohydrate
CELLULOSE, MICROCRYSTALLINE
polyethylene glycol
POLYSORBATE 20
STARCH, CORN
titanium dioxide
zinc stearate
Product Characteristics
Color yellow Score no score
Shape ROUND Size 8mm
Flavor Imprint Code E;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-612-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076402 02/11/2004
BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-326(NDC:0185-0053)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
D&C YELLOW NO. 10 (benazepril) D&C YELLOW NO. 10 10 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
crospovidone
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYDROGENATED CASTOR OIL
hypromellose
lactose monohydrate
CELLULOSE, MICROCRYSTALLINE
polyethylene glycol
POLYSORBATE 20
STARCH, CORN
titanium dioxide
zinc stearate
Product Characteristics
Color orange Score no score
Shape ROUND Size 8mm
Flavor Imprint Code E;53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-326-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:21695-326-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:21695-326-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076402 02/11/2004
BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-327(NDC:0185-0820)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benazepril hydrochloride (benazepril) benazepril hydrochloride 20 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
crospovidone
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYDROGENATED CASTOR OIL
hypromellose
lactose monohydrate
CELLULOSE, MICROCRYSTALLINE
polyethylene glycol
POLYSORBATE 20
STARCH, CORN
titanium dioxide
zinc stearate
Product Characteristics
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code E;82
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-327-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:21695-327-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:21695-327-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076402 02/11/2004
BENAZEPRIL HYDROCHLORIDE
benazepril hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-877(NDC:0185-0048)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benazepril hydrochloride (benazepril) benazepril hydrochloride 40 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
crospovidone
FD&C RED NO. 40
HYDROGENATED CASTOR OIL
hypromellose
lactose monohydrate
CELLULOSE, MICROCRYSTALLINE
polyethylene glycol
POLYSORBATE 20
STARCH, CORN
titanium dioxide
zinc stearate
Product Characteristics
Color red Score no score
Shape ROUND Size 8mm
Flavor Imprint Code E;48
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-877-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:21695-877-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076402 02/11/2004
Labeler — Rebel Distributors Corp. (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp. 118802834 RELABEL, REPACK

Revised: 09/2010 Rebel Distributors Corp.

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