Last Updated: June 26, 2026

Details for New Drug Application (NDA): 202556

✉ Email this page to a colleague

« Back to Dashboard

NDA 202556 describes HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Prinston Inc, Quagen, Sciegen Pharms, Sun Pharm Inds Inc, Unichem, Morton Grove, Roxane, Abc Holding, Accord Hlthcare, Actavis Elizabeth, Alra, Ascot, Aurolife Pharma Llc, Barr, Chartwell Rx, Dava Pharms Inc, Elkins Sinn, Heather, Heritage, Impax Labs, Inwood Labs, Lannett Co Inc, Leading, Mast Mm, Mylan, Oxford Pharms, Pharmobedient, Pvt Form, Solvay, Sun Pharm Industries, Superpharm, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, and Pharmeral, and is included in one hundred and ten NDAs. It is available from forty-three suppliers. Additional details are available on the HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for 202556

Tradename:	HYDROCHLOROTHIAZIDE
Applicant:	Accord Hlthcare
Ingredient:	hydrochlorothiazide
Patents:	0

Pharmacology for NDA: 202556

Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for 202556

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 202556

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	202556	ANDA	Accord Healthcare Inc.	16729-182	16729-182-01	100 TABLET in 1 BOTTLE (16729-182-01)
HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	202556	ANDA	Accord Healthcare Inc.	16729-182	16729-182-17	1000 TABLET in 1 BOTTLE (16729-182-17)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Sep 24, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Sep 24, 2012	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 24, 2012	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.