amlodipine and valsartan (65862-739)

Drug Facts

Product Profile

Brand Name amlodipine and valsartan

Generic Name amlodipine and valsartan

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amlodipine besylate 10 mg/1, valsartan 160 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-739

Product ID 65862-739_909d72a6-7116-407e-8ec8-77b9b5798237

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206512

Listing Expiration 2026-12-31

Marketing Start 2016-04-22

Pharmacologic Class

Established (EPC)

angiotensin 2 receptor blocker [epc]

Mechanism of Action

angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862739

Hyphenated Format 65862-739

Supplemental Identifiers

RxCUI

722126 722131 722134 722137

UPC

0365862739308 0365862737304

UNII

864V2Q084H 80M03YXJ7I

NUI

N0000000070 N0000175561

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 valsartan (source: ndc)

Generic Name amlodipine and valsartan (source: ndc)

Application Number ANDA206512 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
160 mg/1

source: ndc

Packaging

3 BLISTER PACK in 1 CARTON (65862-739-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-739-10)
30 TABLET, FILM COATED in 1 BOTTLE (65862-739-30)
90 TABLET, FILM COATED in 1 BOTTLE (65862-739-90)

source: ndc

Packages (3)

65862-739-03 3 BLISTER PACK in 1 CARTON (65862-739-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-739-10) 65862-739-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-739-30) 65862-739-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-739-90)

Ingredients (2)

amlodipine besylate (10 mg/1) valsartan (160 mg/1)

Linked Drug Pages (1)

Amlodipine and valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "909d72a6-7116-407e-8ec8-77b9b5798237", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0365862739308", "0365862737304"], "unii": ["864V2Q084H", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137"], "spl_set_id": ["7fa25f10-29e0-4162-81a8-9d2e03054ded"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-739-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-739-10)", "package_ndc": "65862-739-03", "marketing_start_date": "20160422"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-739-30)", "package_ndc": "65862-739-30", "marketing_start_date": "20160422"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-739-90)", "package_ndc": "65862-739-90", "marketing_start_date": "20160422"}], "brand_name": "Amlodipine and valsartan", "product_id": "65862-739_909d72a6-7116-407e-8ec8-77b9b5798237", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "65862-739", "generic_name": "Amlodipine and valsartan", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and valsartan", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA206512", "marketing_category": "ANDA", "marketing_start_date": "20160422", "listing_expiration_date": "20261231"}