valsartan and hydrochlorothiazide (71335-0853)

Drug Facts

Product Profile

Brand Name valsartan and hydrochlorothiazide

Generic Name valsartan and hydrochlorothiazide

Labeler bryant ranch prepack

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, valsartan 320 mg/1

Manufacturer

Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0853

Product ID 71335-0853_b6e7eaa2-5cdb-4d2a-8452-e102792cf665

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201662

Listing Expiration 2026-12-31

Marketing Start 2016-05-20

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 713350853

Hyphenated Format 71335-0853

Supplemental Identifiers

RxCUI

636045

UNII

0J48LPH2TH 80M03YXJ7I

NUI

N0000175359 N0000175419 M0471776 N0000000070 N0000175561

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 ANDA201662 (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 (71335-0853-1)
90 TABLET, FILM COATED in 1 BOTTLE (71335-0853-2)

source: ndc

Packages (2)

71335-0853-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-0853-1) 71335-0853-2 90 TABLET, FILM COATED in 1 BOTTLE (71335-0853-2)

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": "b6e7eaa2-5cdb-4d2a-8452-e102792cf665", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["636045"], "spl_set_id": ["d57188d2-c3af-4879-bf17-f37eaf733aca"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0853-1)", "package_ndc": "71335-0853-1", "marketing_start_date": "20180611"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-0853-2)", "package_ndc": "71335-0853-2", "marketing_start_date": "20240709"}], "brand_name": "Valsartan and Hydrochlorothiazide", "product_id": "71335-0853_b6e7eaa2-5cdb-4d2a-8452-e102792cf665", "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": "71335-0853", "generic_name": "Valsartan and Hydrochlorothiazide", "labeler_name": "Bryant Ranch Prepack", "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": "ANDA201662", "marketing_category": "ANDA", "marketing_start_date": "20160520", "listing_expiration_date": "20261231"}