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Data updated: Mar 10, 2026

SODIUM BICARBONATE

SODIUM BICARBONATE
Cardiovascular Approved 2005-11-09
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
13
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Prescription
First Approved
2005-11-09
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

STERISCIENCE Pfizer AMNEAL Fresenius Kabi LONG GROVE PHARMS OMNIVIUM PHARMS INTL MEDICATION SYS EXELA PHARMA ANTHEA PHARMA
Active Ingredient: SODIUM BICARBONATE

SODIUM BICARBONATE Approval History

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What SODIUM BICARBONATE Treats

11 indications

SODIUM BICARBONATE is approved for 11 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Metabolic Acidosis
  • Renal Disease
  • Diabetes
  • Circulatory Insufficiency
  • Shock
  • Dehydration
  • Cardiac Arrest
  • Lactic Acidosis
Source: FDA Label

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SODIUM BICARBONATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminis...

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Data Sources

FDA Approval: ANDA217594 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.