Last Updated: September 24, 2026

Details for New Drug Application (NDA): 078127

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NDA 078127 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-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 078127

Tradename:	ONDANSETRON HYDROCHLORIDE
Applicant:	Pharm Assoc
Ingredient:	ondansetron hydrochloride
Patents:	0

Pharmacology for NDA: 078127

Mechanism of Action	Serotonin 3 Receptor Antagonists

Suppliers and Packaging for NDA: 078127

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	SOLUTION;ORAL	078127	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0882	0121-0882-51	50 mL in 1 BOTTLE, PLASTIC (0121-0882-51)
ONDANSETRON HYDROCHLORIDE	ondansetron hydrochloride	SOLUTION;ORAL	078127	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-4882	0121-4882-94	3 TRAY in 1 CASE (0121-4882-94) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (0121-4882-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 4MG BASE/5ML
Approval Date:	Jun 25, 2007	TE:	AA	RLD:	No

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