Dextrose 5% In Plastic Container

As of Nov 13, 2026, NDA 16730 (Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Dec 21, 1973, with 44 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1973
Review: Standard
Supplements approved: 44
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 45 submissions below

Date	Submission	Status	Documents
Dec 21, 1973	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


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

All 45 submissions, including labeling and manufacturing supplements


May 12, 2026	Supplement 66Labeling · Standard review	Approved	Label Letter
Sep 29, 2014	Supplement 52Manufacturing · Standard review	Approved	None posted
Oct 19, 2006	Supplement 50Labeling	Approved	None posted
Aug 6, 2004	Supplement 48Labeling	Approved	None posted
Jun 23, 1997	Supplement 46Manufacturing · Standard review	Approved	None posted
Aug 8, 1995	Supplement 45Manufacturing · Standard review	Approved	None posted
Dec 31, 1991	Supplement 43Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 42Manufacturing · Standard review	Approved	None posted
Mar 9, 1989	Supplement 39Manufacturing · Standard review	Approved	None posted
Feb 18, 1986	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 30, 1986	Supplement 38Manufacturing · Standard review	Approved	None posted
Sep 16, 1985	Supplement 35Manufacturing · Standard review	Approved	None posted
Jun 24, 1985	Supplement 36Labeling	Approved	None posted
Jun 21, 1985	Supplement 26Manufacturing · Standard review	Approved	None posted
May 17, 1985	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 32Manufacturing · Standard review	Approved	None posted
Oct 17, 1984	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 16, 1984	Supplement 34Labeling	Approved	None posted
Apr 9, 1984	Supplement 31Manufacturing · Standard review	Approved	None posted
Sep 30, 1983	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 24, 1983	Supplement 20Labeling	Approved	None posted
Nov 5, 1982	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 28, 1982	Supplement 23Labeling	Approved	None posted
Jun 28, 1982	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 26, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 30, 1981	Supplement 19Labeling	Approved	None posted
Sep 30, 1981	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 24, 1980	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 6, 1980	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 16, 1980	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 12, 1980	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 16, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 9, 1979	Supplement 13Labeling	Approved	None posted
Jun 8, 1979	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 14, 1979	Supplement 10Labeling	Approved	None posted
Mar 12, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 2, 1978	Supplement 6Labeling	Approved	None posted
Nov 2, 1978	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 12, 1978	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 28, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 21, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 19, 1977	Supplement 3Manufacturing · Standard review	Approved	None posted
May 25, 1977	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 6, 1976	Supplement 1Labeling	Approved	None posted
Dec 21, 1973	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16730
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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

Date

Submission

Status

Documents

Dec 21, 1973

Original applicationNew formulation or manufacturer · Standard review

Approved

None posted

Dextrose 5% In Plastic Container5GM/100ML · injectable;injection

Dextrose

RxReference drug

Dextrose 5% In Plastic Container50MG/ML · injectable;injection

Dextrose

RxReference drug

May 12, 2026

Supplement 66Labeling · Standard review

Approved

Label Letter

Sep 29, 2014

Supplement 52Manufacturing · Standard review

Approved

None posted

Oct 19, 2006

Supplement 50Labeling

Approved

None posted

Aug 6, 2004

Supplement 48Labeling

Approved

None posted

Jun 23, 1997

Supplement 46Manufacturing · Standard review

Approved

None posted

Aug 8, 1995

Supplement 45Manufacturing · Standard review

Approved

None posted

Dec 31, 1991

Supplement 43Manufacturing · Standard review

Approved

None posted

Sep 11, 1990

Supplement 42Manufacturing · Standard review

Approved

None posted

Mar 9, 1989

Supplement 39Manufacturing · Standard review

Approved

None posted

Feb 18, 1986

Supplement 27Manufacturing · Standard review

Approved

None posted

Jan 30, 1986

Supplement 38Manufacturing · Standard review

Approved

None posted

Sep 16, 1985

Supplement 35Manufacturing · Standard review

Approved

None posted

Jun 24, 1985

Supplement 36Labeling

Approved

None posted

Jun 21, 1985

Supplement 26Manufacturing · Standard review

Approved

None posted

May 17, 1985

Supplement 28Manufacturing · Standard review

Approved

None posted

Apr 3, 1985

Supplement 32Manufacturing · Standard review

Approved

None posted

Oct 17, 1984

Supplement 33Manufacturing · Standard review

Approved

None posted

Oct 16, 1984

Supplement 34Labeling

Approved

None posted

Apr 9, 1984

Supplement 31Manufacturing · Standard review

Approved

None posted

Sep 30, 1983

Supplement 29Manufacturing · Standard review

Approved

None posted

Jan 24, 1983

Supplement 20Labeling

Approved

None posted

Nov 5, 1982

Supplement 24Manufacturing · Standard review

Approved

None posted

Jun 28, 1982

Supplement 23Labeling

Approved

None posted

Jun 28, 1982

Supplement 22Manufacturing · Standard review

Approved

None posted

Oct 26, 1981

Supplement 21Manufacturing · Standard review

Approved

None posted

Sep 30, 1981

Supplement 19Labeling

Approved

None posted

Sep 30, 1981

Supplement 18Manufacturing · Standard review

Approved

None posted

Oct 24, 1980

Supplement 17Manufacturing · Standard review

Approved

None posted

Aug 6, 1980

Supplement 16Manufacturing · Standard review

Approved

None posted

Jul 16, 1980

Supplement 15Manufacturing · Standard review

Approved

None posted

Feb 12, 1980

Supplement 14Manufacturing · Standard review

Approved

None posted

Oct 16, 1979

Supplement 12Manufacturing · Standard review

Approved

None posted

Oct 9, 1979

Supplement 13Labeling

Approved

None posted

Jun 8, 1979

Supplement 11Manufacturing · Standard review

Approved

None posted

Mar 14, 1979

Supplement 10Labeling

Approved

None posted

Mar 12, 1979

Supplement 8Manufacturing · Standard review

Approved

None posted

Nov 2, 1978

Supplement 6Labeling

Approved

None posted

Nov 2, 1978

Supplement 5Manufacturing · Standard review

Approved

None posted

Oct 12, 1978

Supplement 9Manufacturing · Standard review

Approved

None posted

Apr 28, 1978

Supplement 7Manufacturing · Standard review

Approved

None posted

Oct 21, 1977

Supplement 4Manufacturing · Standard review

Approved

None posted

Aug 19, 1977

Supplement 3Manufacturing · Standard review

Approved

None posted

May 25, 1977

Supplement 2Manufacturing · Standard review

Approved

None posted

Dec 6, 1976

Supplement 1Labeling

Approved

None posted

Dec 21, 1973

Original applicationNew formulation or manufacturer · Standard review

Approved

None posted