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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 073680

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NDA 073680 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 073680

Tradename:	METOCLOPRAMIDE HYDROCHLORIDE
Applicant:	Chartwell Molecular
Ingredient:	metoclopramide hydrochloride
Patents:	0

Pharmacology for NDA: 073680

Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for 073680

Antiemetics
Dopamine D2 Receptor Antagonists

Suppliers and Packaging for NDA: 073680

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	073680	ANDA	Chartwell RX, LLC	62135-526	62135-526-24	2 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10)
METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	073680	ANDA	Chartwell RX, LLC	62135-526	62135-526-47	473 mL in 1 BOTTLE (62135-526-47)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	Oct 27, 1992	TE:		RLD:	No

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