You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 17, 2025

Details for New Drug Application (NDA): 076178

✉ Email this page to a colleague

« Back to Dashboard

NDA 076178 describes NIZATIDINE, which is a drug marketed by Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Epic Pharma Llc, Glenmark Pharms Inc, Mylan Pharms Inc, Pharmobedient, Watson Labs, and Amneal Pharms, and is included in ten NDAs. It is available from four suppliers. Additional details are available on the NIZATIDINE profile page.

The generic ingredient in NIZATIDINE is nizatidine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nizatidine profile page.

Summary for 076178

Tradename:	NIZATIDINE
Applicant:	Epic Pharma Llc
Ingredient:	nizatidine
Patents:	0

Pharmacology for NDA: 076178

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 076178

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 076178

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIZATIDINE	nizatidine	CAPSULE;ORAL	076178	ANDA	Epic Pharma, LLC	42806-299	42806-299-30	30 CAPSULE in 1 BOTTLE (42806-299-30)
NIZATIDINE	nizatidine	CAPSULE;ORAL	076178	ANDA	Epic Pharma, LLC	42806-299	42806-299-60	60 CAPSULE in 1 BOTTLE (42806-299-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Jul 5, 2002	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Jul 5, 2002	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.