Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075742

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NDA 075742 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Novitium Pharma, Rising, 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, Granules, Heritage Pharma Avet, Mpp Pharma, Mylan, Perrigo, Perrigo R And D, Ph Health, Pharmobedient, 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 is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 075742

Tradename:	RANITIDINE HYDROCHLORIDE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	ranitidine hydrochloride
Patents:	0

Pharmacology for NDA: 075742

Mechanism of Action	Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 075742

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	075742	ANDA	Dr. Reddy's Laboratories Limited	55111-129	55111-129-05	500 CAPSULE in 1 BOTTLE (55111-129-05)
RANITIDINE HYDROCHLORIDE	ranitidine hydrochloride	CAPSULE;ORAL	075742	ANDA	Dr. Reddy's Laboratories Limited	55111-129	55111-129-60	60 CAPSULE in 1 BOTTLE (55111-129-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Nov 29, 2000	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	Nov 29, 2000	TE:	AB	RLD:	No

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