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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 072744

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NDA 072744 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 072744

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

Pharmacology for NDA: 072744

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 072744

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 072744

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	072744	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0576	0121-0576-16	473 mL in 1 BOTTLE (0121-0576-16)
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	072744	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1576	0121-1576-10	10 TRAY in 1 CASE (0121-1576-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	May 28, 1991	TE:	AA	RLD:	No

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