valsartan and hydrochlorothiazide (53746-846)

Drug Facts

Product Profile

Brand Name valsartan and hydrochlorothiazide

Generic Name valsartan and hydrochlorothiazide

Labeler amneal pharmaceuticals of new york llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, valsartan 160 mg/1

Manufacturer

Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-846

Product ID 53746-846_1ed15f09-2051-401f-a320-5f04b85ac8e2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204382

Listing Expiration 2026-12-31

Marketing Start 2023-08-14

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 53746846

Hyphenated Format 53746-846

Supplemental Identifiers

RxCUI

200284 200285 349353 636042 636045

UPC

0353746848901 0353746845900 0353746849908 0353746847904 0353746846907

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 ANDA204382 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
160 mg/1

source: ndc

Packaging

90 TABLET, FILM COATED in 1 BOTTLE (53746-846-90)

source: ndc

Packages (1)

53746-846-90 90 TABLET, FILM COATED in 1 BOTTLE (53746-846-90)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) valsartan (160 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": "1ed15f09-2051-401f-a320-5f04b85ac8e2", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0353746848901", "0353746845900", "0353746849908", "0353746847904", "0353746846907"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200284", "200285", "349353", "636042", "636045"], "spl_set_id": ["d5a1db33-3046-407c-a557-6b41642164a9"], "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": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (53746-846-90)", "package_ndc": "53746-846-90", "marketing_start_date": "20230814"}], "brand_name": "Valsartan and Hydrochlorothiazide", "product_id": "53746-846_1ed15f09-2051-401f-a320-5f04b85ac8e2", "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": "53746-846", "generic_name": "Valsartan and Hydrochlorothiazide", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA204382", "marketing_category": "ANDA", "marketing_start_date": "20230814", "listing_expiration_date": "20261231"}