valsartan and hydrochlorothiazide (68788-8463)

Drug Facts

Product Profile

Brand Name valsartan and hydrochlorothiazide

Generic Name valsartan and hydrochlorothiazide

Labeler preferred pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, valsartan 160 mg/1

Manufacturer

Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8463

Product ID 68788-8463_0324b913-3ee4-4e08-94db-ef5201e4581a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206083

Listing Expiration 2026-12-31

Marketing Start 2023-06-23

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 687888463

Hyphenated Format 68788-8463

Supplemental Identifiers

RxCUI

200285

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 ANDA206083 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
160 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (68788-8463-3)
60 TABLET, FILM COATED in 1 BOTTLE (68788-8463-6)
90 TABLET, FILM COATED in 1 BOTTLE (68788-8463-9)

source: ndc

Packages (3)

68788-8463-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8463-3) 68788-8463-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8463-6) 68788-8463-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8463-9)

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": "0324b913-3ee4-4e08-94db-ef5201e4581a", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200285"], "spl_set_id": ["d09747f0-029e-4090-949b-e939948249b5"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8463-3)", "package_ndc": "68788-8463-3", "marketing_start_date": "20230623"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8463-6)", "package_ndc": "68788-8463-6", "marketing_start_date": "20230623"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8463-9)", "package_ndc": "68788-8463-9", "marketing_start_date": "20230623"}], "brand_name": "VALSARTAN AND HYDROCHLOROTHIAZIDE", "product_id": "68788-8463_0324b913-3ee4-4e08-94db-ef5201e4581a", "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": "68788-8463", "generic_name": "valsartan and hydrochlorothiazide", "labeler_name": "Preferred 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": "ANDA206083", "marketing_category": "ANDA", "marketing_start_date": "20230623", "listing_expiration_date": "20261231"}