Last Updated: April 23, 2026

Details for New Drug Application (NDA): 217535

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NDA 217535 describes SODIUM CHLORIDE 0.9%, which is a drug marketed by Medefil Inc, B Braun, Hikma, Nexus, Spectra Mdcl Devices, Baxter Hlthcare, Fresenius Kabi Usa, Fresenius Medcl, Gvs Tm, Hospira, Laboratorios Grifols, Liebel-flarsheim, Otsuka Icu Medcl, Abbott, Icu Medical Inc, Jubilant Cadista, Miles, Nephron, and Taro, and is included in thirty-four NDAs. It is available from four suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% profile page.

The generic ingredient in SODIUM CHLORIDE 0.9% is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.

Summary for 217535

Tradename:	SODIUM CHLORIDE 0.9%
Applicant:	Nexus
Ingredient:	sodium chloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	90MG/10ML (9MG/ML)
Approval Date:	Aug 23, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	180MG/20ML (9MG/ML)
Approval Date:	Aug 23, 2023	TE:	AP	RLD:	No

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