GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Benazepril Hydrochloride Tablets USP 10mg
C. Benazepril Hydrochloride Tablets USP 20mg
D. Benazepril Hydrochloride Tablets USP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
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:
CAUTION & WARNING:
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:
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.


















