valsartan and hydrochlorothiazide (62332-083)

Drug Facts

Product Profile

Brand Name valsartan and hydrochlorothiazide

Generic Name valsartan and hydrochlorothiazide

Labeler alembic pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, valsartan 320 mg/1

Manufacturer

Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-083

Product ID 62332-083_29d9e9d2-2c11-49c0-b397-cd429cf701df

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 62332083

Hyphenated Format 62332-083

Supplemental Identifiers

RxCUI

200284 200285 349353 636042 636045

UPC

0362332082902 0362332079308 0362332081301

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 ANDA201662 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
320 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 CARTON (62332-083-10)
30 TABLET, FILM COATED in 1 BOTTLE (62332-083-30)
500 TABLET, FILM COATED in 1 BOTTLE (62332-083-71)
90 TABLET, FILM COATED in 1 BOTTLE (62332-083-90)

source: ndc

Packages (4)

62332-083-10 100 TABLET, FILM COATED in 1 CARTON (62332-083-10) 62332-083-30 30 TABLET, FILM COATED in 1 BOTTLE (62332-083-30) 62332-083-71 500 TABLET, FILM COATED in 1 BOTTLE (62332-083-71) 62332-083-90 90 TABLET, FILM COATED in 1 BOTTLE (62332-083-90)

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": "29d9e9d2-2c11-49c0-b397-cd429cf701df", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0362332082902", "0362332079308", "0362332081301"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200284", "200285", "349353", "636042", "636045"], "spl_set_id": ["973973a3-9fec-4afc-910f-187f099dfe2d"], "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": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 CARTON (62332-083-10)", "package_ndc": "62332-083-10", "marketing_start_date": "20160520"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62332-083-30)", "package_ndc": "62332-083-30", "marketing_start_date": "20160520"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (62332-083-71)", "package_ndc": "62332-083-71", "marketing_start_date": "20160520"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62332-083-90)", "package_ndc": "62332-083-90", "marketing_start_date": "20160520"}], "brand_name": "Valsartan and Hydrochlorothiazide", "product_id": "62332-083_29d9e9d2-2c11-49c0-b397-cd429cf701df", "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": "62332-083", "generic_name": "Valsartan and Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Inc.", "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"}