Package 65862-834-05

Brand: amlodipine, valsartan and hydrochlorothiazide

Generic: amlodipine, valsartan and hydrochlorothiazide
NDC Package

Package Facts

Identity

Package NDC 65862-834-05
Digits Only 6586283405
Product NDC 65862-834
Description

500 TABLET, FILM COATED in 1 BOTTLE (65862-834-05)

Marketing

Marketing Status
Marketed Since 2017-12-19
Brand amlodipine, valsartan and hydrochlorothiazide
Generic amlodipine, valsartan and hydrochlorothiazide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "a583a371-730c-4f0a-86b6-01e654770f16", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0365862836304", "0365862835307", "0365862837301", "0365862834300"], "unii": ["0J48LPH2TH", "864V2Q084H", "80M03YXJ7I"], "rxcui": ["848131", "848135", "848140", "848145", "848151"], "spl_set_id": ["6fba5243-ee00-4825-a04a-321cb6b49c56"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [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": "500 TABLET, FILM COATED in 1 BOTTLE (65862-834-05)", "package_ndc": "65862-834-05", "marketing_start_date": "20171219"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-834-30)", "package_ndc": "65862-834-30", "marketing_start_date": "20171219"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-834-90)", "package_ndc": "65862-834-90", "marketing_start_date": "20171219"}], "brand_name": "Amlodipine, Valsartan and Hydrochlorothiazide", "product_id": "65862-834_a583a371-730c-4f0a-86b6-01e654770f16", "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]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "65862-834", "generic_name": "Amlodipine, Valsartan and Hydrochlorothiazide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine, Valsartan and Hydrochlorothiazide", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA206180", "marketing_category": "ANDA", "marketing_start_date": "20171219", "listing_expiration_date": "20261231"}