GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Benazepril Hydrochloride Tablets USP 5mg
B. Benazepril Hydrochloride Tablets USP 10mg
C. Benazepril Hydrochloride Tablets USP 20mg
D. Benazepril Hydrochloride Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Benazepril Hydrochloride Tablets USP 5mg
Each film-coated tablet contains:
Benazepril Hydrochloride USP 5mg
Excipients q.s
Color: Sunset yellow FCF

B. Benazepril Hydrochloride Tablets USP 10mg
Each film-coated tablet contains:
Benazepril Hydrochloride USP 10mg
Excipients q.s
Color: Brilliant blue FCF

C. Benazepril Hydrochloride Tablets USP 20mg
Each film-coated tablet contains:
Benazepril Hydrochloride USP 20mg
Excipients q.s
Color: Tartrazine yellow

D. Benazepril Hydrochloride Tablets USP 40mg
Each film-coated tablet contains:
Benazepril Hydrochloride USP 40mg
Excipients q.s
Color: Carotene

THERAPEUTIC INDICATIONS:

Benazepril is used alone or in combination with other medications to treat high blood pressure. Benazepril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Store in dry place protected from light and moisture
. Dosage: As directed by the Physician
Attach dispensing label as per end county.

Benazepril Hydrochloride Tablets USP 10mg Technical Specification:

Product Name:Benazepril Hydrochloride Tablets USP
Brand Name:Generic
Strength:(5mg), (10mg), (20mg), (40mg)
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antihypertensive
Indication: Benazepril is used alone or in combination with other medications to treat high blood pressure. Benazepril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly.
Storage:Store at 20°C to 25°C (68°F to 77°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Benazepril Hydrochloride Tablets USP 5mg
  • Benazepril Hydrochloride Tablets USP 10mg
  • Benazepril Hydrochloride Tablets USP 20mg
  • Benazepril Hydrochloride Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Benazepril Hydrochloride Tablets USP 5mg
    Each film-coated tablet contains:
    Benazepril Hydrochloride USP         5mg
    Excipients                                             q.s
    Color: Sunset yellow FCF
  • Benazepril Hydrochloride Tablets USP 10mg
    Each film-coated tablet contains:
    Benazepril Hydrochloride USP         10mg
    Excipients                                             q.s
    Color: Brilliant Blue FCF
  • Benazepril Hydrochloride Tablets USP 20mg
    Each film-coated tablet contains:
    Benazepril Hydrochloride USP         20mg
    Excipients                                             q.s
    Color: Tartrazine yellow
  • Benazepril Hydrochloride Tablets USP 40mg
    Each film-coated tablet contains:
    Benazepril Hydrochloride USP         40mg
    Excipients                                                q.s
    Color: Carotene

THERAPEUTIC INDICATIONS:

Benazepril is used alone or in combination with other medications to treat high blood pressure. Benazepril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Keep container tightly closed.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician
Attach dispensing label as per end county.