amlodipine and valsartan (65862-737)

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 5 mg/1, valsartan 160 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-737

Product ID 65862-737_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 65862737

Hyphenated Format 65862-737

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

5 mg/1
160 mg/1

source: ndc

Packaging

3 BLISTER PACK in 1 CARTON (65862-737-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-737-10)
30 TABLET, FILM COATED in 1 BOTTLE (65862-737-30)
90 TABLET, FILM COATED in 1 BOTTLE (65862-737-90)

source: ndc

Packages (3)

65862-737-03 3 BLISTER PACK in 1 CARTON (65862-737-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-737-10) 65862-737-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-737-30) 65862-737-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-737-90)

Ingredients (2)

amlodipine besylate (5 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 (65862-737-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-737-10)", "package_ndc": "65862-737-03", "marketing_start_date": "20160422"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-737-30)", "package_ndc": "65862-737-30", "marketing_start_date": "20160422"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-737-90)", "package_ndc": "65862-737-90", "marketing_start_date": "20160422"}], "brand_name": "Amlodipine and valsartan", "product_id": "65862-737_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": "65862-737", "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": "5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA206512", "marketing_category": "ANDA", "marketing_start_date": "20160422", "listing_expiration_date": "20261231"}