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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203018

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NDA 203018 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 Inc, 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-two 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 203018

Tradename:	HYDROCHLOROTHIAZIDE
Applicant:	Sciegen Pharms Inc
Ingredient:	hydrochlorothiazide
Patents:	0

Pharmacology for NDA: 203018

Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for 203018

Antihypertensive Agents
Diuretics
Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 203018

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	203018	ANDA	ScieGen Pharmaceuticals, Inc.	50228-111	50228-111-10	1000 TABLET in 1 BOTTLE (50228-111-10)
HYDROCHLOROTHIAZIDE	hydrochlorothiazide	TABLET;ORAL	203018	ANDA	ScieGen Pharmaceuticals, Inc.	50228-111	50228-111-30	30 TABLET in 1 BOTTLE (50228-111-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 23, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 23, 2014	TE:	AB	RLD:	No

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