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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 076960

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NDA 076960 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 076960

Tradename:	ONDANSETRON HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	ondansetron hydrochloride
Patents:	0

Pharmacology for NDA: 076960

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 076960

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	SOLUTION;ORAL	076960	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0064	0054-0064-47	1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	SOLUTION;ORAL	076960	ANDA	Precision Dose Inc.	68094-763	68094-763-62	3 TRAY in 1 CASE (68094-763-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-763-59)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 4MG BASE/5ML
Approval Date:	Dec 26, 2006	TE:	AA	RLD:	No

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