Sodium Chloride 14.6%, Sodium Chloride 23.4%

For restricted oral intake. NDA 18897, held by Hospira. Sodium Chloride.

As of Nov 13, 2026, NDA 18897 (Sodium Chloride 14.6%, Sodium Chloride 23.4%), held by Hospira, was first approved by FDA on Jul 20, 1984, with 18 approved supplements and 0 published complete response letters.

First approved: Jul 20, 1984
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 14.6% Sodium Chloride Injection, USP Additive Solution is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jul 20, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Sodium Chloride 14.6%50MEQ/20ML (2.5MEQ/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intravenous	Sodium Chloride	DiscontinuedReference drug
Sodium Chloride 14.6%100MEQ/40ML (2.5MEQ/ML) · solution;intravenous	Sodium Chloride	RxReference drug
Sodium Chloride 23.4%400MEQ/100ML (4MEQ/ML) · solution;intravenous	Sodium Chloride	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Jun 18, 2020	Supplement 24Manufacturing · Standard review	Approved	Label
Jun 12, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 12, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 14, 2002	Supplement 16Labeling · Standard review	Approved	Letter
Jun 7, 2001	Supplement 11Labeling · Standard review	Approved	None posted
Feb 16, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 9, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Aug 31, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 13, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 17, 1997	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 29, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 8, 1992	Supplement 7Labeling	Approved	None posted
Oct 21, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 11, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 4, 1986	Supplement 3Labeling	Approved	None posted
Sep 4, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 25, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 20, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18897
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