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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078807

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NDA 078807 describes METOCLOPRAMIDE HYDROCHLORIDE, which is a drug marketed by Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, 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-three NDAs. It is available from thirty-three suppliers. Additional details are available on the METOCLOPRAMIDE HYDROCHLORIDE profile page.

The generic ingredient in METOCLOPRAMIDE HYDROCHLORIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-six 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	Ipca Laboratories Limited	83980-010	83980-010-01	100 TABLET in 1 BOTTLE (83980-010-01)
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	078807	ANDA	Ipca Laboratories Limited	83980-010	83980-010-05	500 TABLET in 1 BOTTLE (83980-010-05)

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

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