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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 091392

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NDA 091392 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-one 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-five suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 091392

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	metoclopramide hydrochloride
Patents:	0

Pharmacology for NDA: 091392

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 091392

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 091392

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	091392	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1367	51662-1367-1	1 SYRINGE, GLASS in 1 BLISTER PACK (51662-1367-1) / 2 mL in 1 SYRINGE, GLASS
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	091392	ANDA	Fresenius Kabi USA, LLC	76045-101	76045-101-20	24 BLISTER PACK in 1 CARTON (76045-101-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-101-00) / 2 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Apr 19, 2013	TE:		RLD:	No

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