Last Updated: November 8, 2026

Details for New Drug Application (NDA): 217072

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NDA 217072 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 217072

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Baxter Hlthcare Corp
Ingredient:	metoclopramide hydrochloride
Patents:	0

Pharmacology for NDA: 217072

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 217072

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 217072

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	217072	ANDA	Baxter Healthcare Corporation	36000-366	36000-366-25	25 VIAL, SINGLE-DOSE in 1 CARTON (36000-366-25) / 2 mL in 1 VIAL, SINGLE-DOSE (36000-366-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Sep 11, 2026	TE:	AP	RLD:	No

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