Sodium Chloride 0.9% In Plastic Container

NDA 19465, held by Hospira. Sodium Chloride.

As of Nov 13, 2026, NDA 19465 (Sodium Chloride 0.9% In Plastic Container), held by Hospira, was first approved by FDA on Jul 15, 1985, with 35 approved supplements and 0 published complete response letters.

First approved: Jul 15, 1985
Review: Standard
Supplements approved: 35
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. In this dosage form, Sodium Chloride Injection, USP is intended to be used as a diluent for the contents of an ADD-Vantage vial, or single-dose vials with 20 mm closure using the ADD-Vantage ADDAPTOR.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Jul 15, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Sodium Chloride 0.9% In Plastic Container900MG/100ML · solution;injection	Sodium Chloride	RxReference drug
Sodium Chloride 0.9% In Plastic Container450MG/50ML (9MG/ML) · solution;injection	Sodium Chloride	RxReference drug

All 36 submissions, including labeling and manufacturing supplements


May 29, 2019	Supplement 58Manufacturing	Approved	None posted
Sep 27, 2016	Supplement 55Labeling · Standard review	Approved	Letter Label
Jun 10, 2016	Supplement 54Labeling · Standard review	Approved	Letter
Nov 1, 2002	Supplement 38Manufacturing · Standard review	Approved	None posted
Apr 6, 2000	Supplement 37Manufacturing · Standard review	Approved	None posted
Apr 6, 2000	Supplement 36Labeling	Approved	None posted
Apr 6, 2000	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 2, 1999	Supplement 31Labeling	Approved	None posted
Dec 1, 1998	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 33Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 32Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 24, 1996	Supplement 27Manufacturing · Standard review	Approved	None posted
May 31, 1995	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 5, 1995	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 23, 1994	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 21, 1994	Supplement 24Labeling	Approved	None posted
Feb 25, 1994	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 16, 1993	Supplement 15Labeling	Approved	None posted
Jan 28, 1992	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 30, 1991	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 2, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 9, 1990	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 20, 1989	Supplement 8Labeling	Approved	None posted
Aug 3, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 18, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 6, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
May 27, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 17, 1986	Supplement 1Labeling	Approved	None posted
Jul 15, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19465
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