amlodipine and benazepril hydrochloride (65862-583)

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 5 mg/1, benazepril hydrochloride 10 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-583

Product ID 65862-583_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 65862583

Hyphenated Format 65862-583

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

5 mg/1
10 mg/1

source: ndc

Packaging

100 CAPSULE in 1 BOTTLE (65862-583-01)
500 CAPSULE in 1 BOTTLE (65862-583-05)

source: ndc

Packages (2)

65862-583-01 100 CAPSULE in 1 BOTTLE (65862-583-01) 65862-583-05 500 CAPSULE in 1 BOTTLE (65862-583-05)

Ingredients (2)

amlodipine besylate (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 (65862-583-01)", "package_ndc": "65862-583-01", "marketing_start_date": "20120905"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65862-583-05)", "package_ndc": "65862-583-05", "marketing_start_date": "20120905"}], "brand_name": "Amlodipine and Benazepril Hydrochloride", "product_id": "65862-583_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": "65862-583", "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": "5 mg/1"}, {"name": "BENAZEPRIL HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA202239", "marketing_category": "ANDA", "marketing_start_date": "20120905", "listing_expiration_date": "20261231"}