Dextrose 5% In Plastic Container

NDA 20179, held by Baxter Hlthcare. Dextrose.

As of Nov 13, 2026, NDA 20179 (Dextrose 5% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Dec 7, 1992, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 7, 1992
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dextrose Injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 20 mm closure. Dextrose Injection is indicated as a source of calories and water and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 20 mm closure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Dec 7, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Dextrose 5% In Plastic Container5GM/100ML · injectable;injection	Dextrose	RxReference drug
Dextrose 5% In Plastic Container50MG/ML · injectable;injection	Dextrose	RxReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2022	Supplement 26Manufacturing	Approved	Letter
Aug 5, 2019	Supplement 56Labeling · Standard review	Approved	Label
Aug 5, 2019	Supplement 12Labeling · Standard review	Approved	Label Letter
Nov 20, 2003	Supplement 7Labeling	Approved	None posted
May 4, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 15, 1999	Supplement 3Labeling	Approved	None posted
Dec 29, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 7, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20179
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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