Last Updated: September 29, 2026

Details for New Drug Application (NDA): 209389

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NDA 209389 describes ONDANSETRON, which is a drug marketed by Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Pharms Ltd, Ipca Labs Ltd, Nesher Pharms, Pharmobedient, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, 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, Sun Pharm Inds (in), Wockhardt Bio Ag, Amneal Pharms, Pharm Assoc, Taro, Apotex, Chartwell Rx, Dr Reddys Labs Ltd, Hikma Intl Pharms, Natco Pharma Ltd, and Taro Pharms Ireland, and is included in seventy-nine NDAs. It is available from thirty suppliers. Additional details are available on the ONDANSETRON profile page.

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

Summary for 209389

Tradename:	ONDANSETRON
Applicant:	Ipca Labs Ltd
Ingredient:	ondansetron
Patents:	0

Pharmacology for NDA: 209389

Mechanism of Action	Serotonin 3 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 209389

Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Serotonin Antagonists

Suppliers and Packaging for NDA: 209389

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	209389	ANDA	Bryant Ranch Prepack	71335-2972	71335-2972-1	20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-1)
ONDANSETRON	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	209389	ANDA	Bryant Ranch Prepack	71335-2972	71335-2972-2	60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	4MG
Approval Date:	Oct 30, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	8MG
Approval Date:	Oct 30, 2023	TE:	AB	RLD:	No

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