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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 077557

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NDA 077557 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-four suppliers. Additional details are available on the ONDANSETRON profile page.

The generic ingredient in ONDANSETRON 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 077557

Tradename:	ONDANSETRON
Applicant:	Sun Pharm Inds
Ingredient:	ondansetron
Patents:	0

Pharmacology for NDA: 077557

Mechanism of Action	Serotonin 3 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 077557

Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Serotonin Antagonists

Suppliers and Packaging for NDA: 077557

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	077557	ANDA	Cardinal Health 107, LLC	55154-4567	55154-4567-0	10 BLISTER PACK in 1 BAG (55154-4567-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ONDANSETRON	ondansetron	TABLET, ORALLY DISINTEGRATING;ORAL	077557	ANDA	St. Mary's Medical Park Pharmacy	60760-313	60760-313-10	10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (60760-313-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	4MG
Approval Date:	Aug 2, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	8MG
Approval Date:	Aug 2, 2007	TE:	AB	RLD:	No

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