amlodipine, valsartan and hydrochlorothiazide

Generic: amlodipine, valsartan and hydrochlorothiazide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine, valsartan and hydrochlorothiazide
Generic Name amlodipine, valsartan and hydrochlorothiazide
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, hydrochlorothiazide 25 mg/1, valsartan 160 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-835
Product ID 65862-835_a583a371-730c-4f0a-86b6-01e654770f16
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206180
Listing Expiration 2026-12-31
Marketing Start 2017-12-19

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862835
Hyphenated Format 65862-835

Supplemental Identifiers

RxCUI
848131 848135 848140 848145 848151
UPC
0365862836304 0365862835307 0365862837301 0365862834300
UNII
0J48LPH2TH 864V2Q084H 80M03YXJ7I
NUI
N0000175359 N0000175419 M0471776 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, valsartan and hydrochlorothiazide (source: ndc)
Generic Name amlodipine, valsartan and hydrochlorothiazide (source: ndc)
Application Number ANDA206180 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 25 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-835-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-835-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-835-90)
source: ndc

Packages (3)

65862-835-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-835-05) 65862-835-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-835-30) 65862-835-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-835-90)

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (25 mg/1) valsartan (160 mg/1)

Linked Drug Pages (1)

Amlodipine, Valsartan and Hydrochlorothiazide ndc-match (0.9)

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 (65862-835-05)", "package_ndc": "65862-835-05", "marketing_start_date": "20171219"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-835-30)", "package_ndc": "65862-835-30", "marketing_start_date": "20171219"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-835-90)", "package_ndc": "65862-835-90", "marketing_start_date": "20171219"}], "brand_name": "Amlodipine, Valsartan and Hydrochlorothiazide", "product_id": "65862-835_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": "65862-835", "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": "25 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA206180", "marketing_category": "ANDA", "marketing_start_date": "20171219", "listing_expiration_date": "20261231"}