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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 076974

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NDA 076974 describes ONDANSETRON HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Am Regent, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Onesource Specialty, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Sandoz, Sun Pharm Inds (in), Teva, Wockhardt Bio Ag, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Chartwell Molecules, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma Intl Pharms, Ipca Labs Ltd, Natco Pharma Ltd, Sun Pharm Inds Ltd, and Taro Pharms Ireland, and is included in sixty-eight NDAs. It is available from sixty-seven suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for 076974

Tradename:	ONDANSETRON HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	ondansetron hydrochloride
Patents:	0

Pharmacology for NDA: 076974

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 076974

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	076974	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1377	51662-1377-1	20 mL in 1 VIAL (51662-1377-1)
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	INJECTABLE;INJECTION	076974	ANDA	Fresenius Kabi USA, LLC	63323-374	63323-374-20	1 VIAL in 1 BOX (63323-374-20) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/ML
Approval Date:	Dec 26, 2006	TE:	AP	RLD:	No

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