Sodium Chloride 0.9% In Plastic Container

NDA 18803, held by Hospira. Sodium Chloride.

As of Nov 13, 2026, NDA 18803 (Sodium Chloride 0.9% In Plastic Container), held by Hospira, was first approved by FDA on Oct 29, 1982, with 16 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1982
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Oct 29, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

6 strengths and forms


Sodium Chloride 0.9% In Plastic Container90MG/10ML (9MG/ML) · solution;injection	Sodium Chloride	RxReference drug
Sodium Chloride 0.9% In Plastic Container180MG/20ML (9MG/ML) · solution;injection	Sodium Chloride	RxReference drug
Sodium Chloride 0.9% In Plastic Container450MG/50ML (9MG/ML) · solution;injection	Sodium Chloride	RxReference drug
Sodium Chloride 0.9% In Plastic Container18MG/2ML (9MG/ML) · solution;injection	Sodium Chloride	DiscontinuedReference drug
Sodium Chloride 0.9% In Plastic Container27MG/3ML (9MG/ML) · solution;injection	Sodium Chloride	DiscontinuedReference drug
Sodium Chloride 0.9% In Plastic Container45MG/5ML (9MG/ML) · solution;injection	Sodium Chloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Jan 26, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 12, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 12, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 12, 2001	Supplement 12Labeling · Standard review	Approved	None posted
Feb 16, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 31, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 17, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 10, 1989	Supplement 7Labeling	Approved	None posted
Mar 24, 1988	Supplement 8Labeling	Approved	None posted
Feb 25, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 15, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 14, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 25, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 17, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 29, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18803
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters