valsartan and hydrochlorothiazide (43547-315)

Drug Facts

Product Profile

Brand Name valsartan and hydrochlorothiazide

Generic Name valsartan and hydrochlorothiazide

Labeler solco healthcare us, llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, valsartan 320 mg/1

Manufacturer

Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-315

Product ID 43547-315_1b876e29-1212-4e28-8d3c-e2e717a8fe53

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206083

Listing Expiration 2026-12-31

Marketing Start 2015-10-31

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 43547315

Hyphenated Format 43547-315

Supplemental Identifiers

RxCUI

200284 200285 349353 636042 636045

UPC

0343547313036 0343547314033 0343547315030 0343547311032 0343547312039

UNII

0J48LPH2TH 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 valsartan and hydrochlorothiazide (source: ndc)

Generic Name valsartan and hydrochlorothiazide (source: ndc)

Application Number ANDA206083 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
320 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (43547-315-03)
90 TABLET, FILM COATED in 1 BOTTLE (43547-315-09)
500 TABLET, FILM COATED in 1 BOTTLE (43547-315-50)

source: ndc

Packages (3)

43547-315-03 30 TABLET, FILM COATED in 1 BOTTLE (43547-315-03) 43547-315-09 90 TABLET, FILM COATED in 1 BOTTLE (43547-315-09) 43547-315-50 500 TABLET, FILM COATED in 1 BOTTLE (43547-315-50)

Ingredients (2)

hydrochlorothiazide (25 mg/1) valsartan (320 mg/1)

Linked Drug Pages (1)

VALSARTAN AND HYDROCHLOROTHIAZIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1b876e29-1212-4e28-8d3c-e2e717a8fe53", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0343547313036", "0343547314033", "0343547315030", "0343547311032", "0343547312039"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200284", "200285", "349353", "636042", "636045"], "spl_set_id": ["f8b0a8ab-4549-4553-a127-bf2c0291a4b1"], "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": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43547-315-03)", "package_ndc": "43547-315-03", "marketing_start_date": "20211203"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43547-315-09)", "package_ndc": "43547-315-09", "marketing_start_date": "20211203"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43547-315-50)", "package_ndc": "43547-315-50", "marketing_start_date": "20211203"}], "brand_name": "VALSARTAN AND HYDROCHLOROTHIAZIDE", "product_id": "43547-315_1b876e29-1212-4e28-8d3c-e2e717a8fe53", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "43547-315", "generic_name": "valsartan and hydrochlorothiazide", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VALSARTAN AND HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "VALSARTAN", "strength": "320 mg/1"}], "application_number": "ANDA206083", "marketing_category": "ANDA", "marketing_start_date": "20151031", "listing_expiration_date": "20261231"}