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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 073135

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NDA 073135 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 073135

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

Pharmacology for NDA: 073135

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 073135

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 073135

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	073135	ANDA	Teva Parenteral Medicines, Inc.	0703-4502	0703-4502-04	25 VIAL, SINGLE-USE in 1 TRAY (0703-4502-04) / 2 mL in 1 VIAL, SINGLE-USE (0703-4502-01)
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	073135	ANDA	Teva Parenteral Medicines, Inc.	0703-4502	0703-4502-93	10 VIAL, SINGLE-USE in 1 CARTON (0703-4502-93) / 2 mL in 1 VIAL, SINGLE-USE (0703-4502-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Nov 27, 1991	TE:	AP	RLD:	No

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