Last Updated: June 9, 2026

Details for New Drug Application (NDA): 072801

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NDA 072801 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-eight suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 072801

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Teva
Ingredient:	metoclopramide hydrochloride
Patents:	0

Pharmacology for NDA: 072801

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 072801

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 072801

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	072801	ANDA	Teva Pharmaceuticals USA, Inc.	0093-2204	0093-2204-01	100 TABLET in 1 BOTTLE (0093-2204-01)
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	072801	ANDA	Teva Pharmaceuticals USA, Inc.	0093-2204	0093-2204-05	500 TABLET in 1 BOTTLE (0093-2204-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jun 15, 1993	TE:	AB	RLD:	No

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