Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078807

« Back to Dashboard

NDA 078807 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Baxter Hlthcare Corp, Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Morton Grove, Paco, Pai Holdings, Pharmobedient Cnsltg, Roxane, Teva, Vistapharm Llc, Novel Labs Inc, Aiping Pharm Inc, Chartwell Rx, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Sandoz, Schering, Strides Pharma Intl, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in fifty-four NDAs. It is available from thirty-six suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 078807

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Ipca Labs Ltd
Ingredient:	metoclopramide hydrochloride
Patents:	0

Pharmacology for NDA: 078807

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 078807

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 078807

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	078807	ANDA	Redpharm Drug	67296-2309	67296-2309-2	15 TABLET in 1 BOTTLE (67296-2309-2)
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	078807	ANDA	NuCare Pharmaceuticals, Inc.	68071-5303	68071-5303-3	30 TABLET in 1 BOTTLE (68071-5303-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jun 12, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 12, 2008	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.