Sodium Bicarbonate

For clinically significant metabolic acidosis. NDA 218524, held by Baxter Hlthcare Corp. Sodium Bicarbonate.

As of Nov 13, 2026, NDA 218524 (Sodium Bicarbonate), held by Baxter Hlthcare Corp, was first approved by FDA on Aug 14, 2026, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 14, 2026
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sodium bicarbonate injection is an alkalinizing agent indicated:

to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis.
to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 14, 2026	Original applicationNew formulation or manufacturer · Standard review	Approved	Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Bicarbonate150MEQ/1000ML (0.15MEQ/ML) · solution;intravenous	Sodium Bicarbonate	RxReference drug

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 6, 2026	Supplement 1Labeling · Standard review	Approved	Letter
Aug 14, 2026	Original applicationNew formulation or manufacturer · Standard review	Approved	Label Letter

Identifiers

Application: NDA 218524
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