Amlodipine 5 MG Benazepril hydrochloride 20 MG Oral Capsule
1 INDICATIONS AND USAGE Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (1) 1.1 Hypertension Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Aurobindo Pharma Limited
CAPSULE PINK I 98
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16 HOW SUPPLIED/STORAGE AND HANDLING
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE is available as capsules containing amlodipine besylate USP (3.5 mg, 6.9 mg or 13.9 mg, equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine respectively), with 10 mg, 20 mg, or 40 mg of benazepril hydrochloride USP providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. They are available as follows:
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules USP, 2.5 mg/10 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of white cap and white body imprinted with ‘I’ on white cap and ‘96’ on white body with black edible ink. Bottles of 100 NDC 65862-582-01 Bottles of 500 NDC 65862-582-05
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules USP, 5 mg/10 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of light brown cap and light brown body imprinted with ‘I’ on light brown cap and ‘97’ on light brown body with black edible ink. Bottles of 100 NDC 65862-583-01 Bottles of 500 NDC 65862-583-05
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules USP, 5 mg/20 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of pink cap and pink body imprinted with ‘I’ on pink cap and ‘98’ on pink body with black edible ink. Bottles of 100 NDC 65862-584-01 Bottles of 500 NDC 65862-584-05
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules USP, 5 mg/40 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of light blue cap and light blue body imprinted with ‘J’ on light blue cap and ‘01’ on light blue body with black edible ink. Bottles of 100 NDC 65862-585-01 Bottles of 500 NDC 65862-585-05
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules USP, 10 mg/20 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of purple cap and purple body imprinted with ‘J’ on purple cap and ‘02’ on purple body with black edible ink. Bottles of 100 NDC 65862-586-01 Bottles of 500 NDC 65862-586-05
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules USP, 10 mg/40 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of dark blue cap and dark blue body imprinted with ‘J’ on dark blue cap and ‘03’ on dark blue body with black edible ink. Bottles of 100 NDC 65862-587-01 Bottles of 500 NDC 65862-587-05 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
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