Last Updated: May 10, 2026

Details for New Drug Application (NDA): 071402

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NDA 071402 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-two 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-seven suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

Summary for 071402

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Ani Pharms
Ingredient:	metoclopramide hydrochloride
Patents:	0

Pharmacology for NDA: 071402

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 071402

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 071402

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	071402	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-1190	17856-1190-1	72 CUP, UNIT-DOSE in 1 CASE (17856-1190-1) / 5 mL in 1 CUP, UNIT-DOSE
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	071402	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-1190	17856-1190-2	120 SYRINGE in 1 CASE (17856-1190-2) / 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	Jun 25, 1993	TE:	AA	RLD:	No

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