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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 210243

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NDA 210243 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Novitium Pharma, Pharmobedient, Sandoz, Teva, Bedford, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Epic Pharma Llc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Sun Pharma Canada, Tolmar, Torrent, Wockhardt, Amneal Pharms Ny, Ani Pharms, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Mpp Pharma, Mylan, Perrigo, Perrigo R And D, Ph Health, Strides Pharma, Sun Pharm Inds Ltd, Thinq Pharm-cro Pvt, Vkt Pharma, Watson Labs, and Wockhardt Ltd, and is included in seventy-five NDAs. It is available from nine suppliers. Additional details are available on the RANITIDINE HYDROCHLORIDE profile page.

The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 210243

Tradename:	RANITIDINE HYDROCHLORIDE
Applicant:	Granules
Ingredient:	ranitidine hydrochloride
Patents:	0

Pharmacology for NDA: 210243

Mechanism of Action	Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 210243

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	210243	ANDA	Granules India Ltd	62207-773	62207-773-36	5 BAG in 1 CARTON (62207-773-36) / 10000 TABLET in 1 BAG (62207-773-32)
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	210243	ANDA	Granules India Ltd	62207-773	62207-773-41	1 BOTTLE in 1 CARTON (62207-773-41) / 24 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Aug 20, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Aug 20, 2018	TE:		RLD:	No

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