amlodipine and benazepril hydrochloride (65862-582)

Drug Facts

Product Profile

Brand Name amlodipine and benazepril hydrochloride

Generic Name amlodipine and benazepril hydrochloride

Labeler aurobindo pharma limited

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

amlodipine besylate 2.5 mg/1, benazepril hydrochloride 10 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-582

Product ID 65862-582_a45ec3e8-1d14-4c27-9685-976323df8cad

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202239

Listing Expiration 2026-12-31

Marketing Start 2012-09-05

Pharmacologic Class

Classes

angiotensin converting enzyme inhibitor [epc] angiotensin-converting enzyme inhibitors [moa] calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] decreased blood pressure [pe] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862582

Hyphenated Format 65862-582

Supplemental Identifiers

RxCUI

898342 898346 898350 898353 898356 898359

UNII

864V2Q084H N1SN99T69T

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amlodipine and benazepril hydrochloride (source: ndc)

Generic Name amlodipine and benazepril hydrochloride (source: ndc)

Application Number ANDA202239 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2.5 mg/1
10 mg/1

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE (65862-582-01)
500 CAPSULE in 1 BOTTLE (65862-582-05)

source: ndc

Packages (2)

65862-582-01 100 CAPSULE in 1 BOTTLE (65862-582-01) 65862-582-05 500 CAPSULE in 1 BOTTLE (65862-582-05)

Ingredients (2)

amlodipine besylate (2.5 mg/1) benazepril hydrochloride (10 mg/1)

Linked Drug Pages (1)

Amlodipine and Benazepril Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "a45ec3e8-1d14-4c27-9685-976323df8cad", "openfda": {"unii": ["864V2Q084H", "N1SN99T69T"], "rxcui": ["898342", "898346", "898350", "898353", "898356", "898359"], "spl_set_id": ["99ed4927-9a34-4e8d-8eea-60b63c867d46"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65862-582-01)", "package_ndc": "65862-582-01", "marketing_start_date": "20120905"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65862-582-05)", "package_ndc": "65862-582-05", "marketing_start_date": "20120905"}], "brand_name": "Amlodipine and Benazepril Hydrochloride", "product_id": "65862-582_a45ec3e8-1d14-4c27-9685-976323df8cad", "dosage_form": "CAPSULE", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Decreased Blood Pressure [PE]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "65862-582", "generic_name": "Amlodipine and Benazepril Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and Benazepril Hydrochloride", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "2.5 mg/1"}, {"name": "BENAZEPRIL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA202239", "marketing_category": "ANDA", "marketing_start_date": "20120905", "listing_expiration_date": "20261231"}