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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 211289

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NDA 211289 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 seven 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. Seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 211289

Tradename:	RANITIDINE HYDROCHLORIDE
Applicant:	Vkt Pharma
Ingredient:	ranitidine hydrochloride
Patents:	0

Pharmacology for NDA: 211289

Mechanism of Action	Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 211289

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	211289	ANDA	Rising Pharma Holdings, Inc.	64980-636	64980-636-03	30 TABLET in 1 BOTTLE (64980-636-03)
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	TABLET;ORAL	211289	ANDA	Rising Pharma Holdings, Inc.	64980-637	64980-637-03	30 TABLET in 1 BOTTLE (64980-637-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Jan 31, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE
Approval Date:	Jan 31, 2019	TE:	AB	RLD:	No

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