valsartan and hydrochlorothiazide (0378-6322)

Drug Facts

Product Profile

Brand Name valsartan and hydrochlorothiazide

Generic Name valsartan and hydrochlorothiazide

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, valsartan 160 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6322

Product ID 0378-6322_16044239-373d-4b04-9a4d-fd4232a93b6c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078020

Listing Expiration 2026-12-31

Marketing Start 2012-09-21

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 03786322

Hyphenated Format 0378-6322

Supplemental Identifiers

RxCUI

200284 200285 349353 636042 636045

UPC

0303786323777

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 ANDA078020 (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, PLASTIC (0378-6322-77)

source: ndc

Packages (1)

0378-6322-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6322-77)

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": "16044239-373d-4b04-9a4d-fd4232a93b6c", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0303786323777"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200284", "200285", "349353", "636042", "636045"], "spl_set_id": ["3ba1f9f9-0037-4522-8605-e27dc8552b5b"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6322-77)", "package_ndc": "0378-6322-77", "marketing_start_date": "20120921"}], "brand_name": "Valsartan and Hydrochlorothiazide", "product_id": "0378-6322_16044239-373d-4b04-9a4d-fd4232a93b6c", "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": "0378-6322", "generic_name": "valsartan and hydrochlorothiazide", "labeler_name": "Mylan Pharmaceuticals Inc.", "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": "ANDA078020", "marketing_category": "ANDA", "marketing_start_date": "20120921", "listing_expiration_date": "20261231"}