Last Updated: November 9, 2026

Details for New Drug Application (NDA): 077851

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NDA 077851 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, 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-eight suppliers. Additional details are available on the ONDANSETRON HYDROCHLORIDE profile page.

The generic ingredient in ONDANSETRON HYDROCHLORIDE is ondansetron hydrochloride. There is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.

Summary for 077851

Tradename:	ONDANSETRON HYDROCHLORIDE
Applicant:	Natco Pharma Ltd
Ingredient:	ondansetron hydrochloride
Patents:	0

Pharmacology for NDA: 077851

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 077851

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	077851	ANDA	Golden State Medical Supply, Inc.	51407-003	51407-003-05	500 TABLET in 1 BOTTLE (51407-003-05)
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	TABLET;ORAL	077851	ANDA	Golden State Medical Supply, Inc.	51407-003	51407-003-30	30 TABLET in 1 BOTTLE (51407-003-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Jun 25, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 8MG BASE
Approval Date:	Jun 25, 2007	TE:	AB	RLD:	No

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