Last Updated: September 24, 2026

Details for New Drug Application (NDA): 090469

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NDA 090469 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 090469

Tradename:	ONDANSETRON
Applicant:	Aurobindo Pharma
Ingredient:	ondansetron
Patents:	0

Pharmacology for NDA: 090469

Mechanism of Action	Serotonin 3 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 090469

Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Serotonin Antagonists

Suppliers and Packaging for NDA: 090469

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	090469	ANDA	NorthStar Rx LLC	16714-200	16714-200-30	3 BLISTER PACK in 1 CARTON (16714-200-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (16714-200-10)
ONDANSETRON	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	090469	ANDA	NorthStar Rx LLC	16714-201	16714-201-10	1 BLISTER PACK in 1 CARTON (16714-201-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	4MG
Approval Date:	Apr 12, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	8MG
Approval Date:	Apr 12, 2010	TE:	AB	RLD:	No

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