TheraRadar
Data updated: May 26, 2026

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (epinephrine bitartrate)

Other Approved 2025-02-28

This medication helps patients manage pain during dental procedures by providing local, infiltrative, or conductive anesthesia. It is used for both simple and complex dental work in adults and children four years of age and older. The combination of a local anesthetic and a vasoconstrictor ensures that the numbing effect remains concentrated where it is needed during the procedure.

Source: FDA Label • Baxter

How EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Works

This drug works by blocking the generation and conduction of nerve impulses, which prevents pain signals from traveling along the nerve fibers. The addition of epinephrine narrows blood vessels to slow the absorption of the anesthetic into the bloodstream, which helps maintain the medication's presence in the local tissue for a longer duration.

1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2025-02-28
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: EPINEPHRINE BITARTRATE

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Approval History

2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2025
Feb 2025 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Treats

5 indications

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is approved for 5 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Simple dental procedures
  • Complex dental procedures
  • Local anesthesia
  • Infiltrative anesthesia
  • Conductive anesthesia
Source: FDA Label

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Unlock 3 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

3 of 5

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

SEPTOCAINE
ARTICAINE HYDROCHLORIDE
2 shared
DEPROCO
Shared indications:
Simple dental proceduresComplex dental procedures
GOPRELTO
COCAINE HYDROCHLORIDE
1 shared
LXO IRELAND
Shared indications:
Local Anesthesia
NESACAINE-MPF
CHLOROPROCAINE HYDROCHLORIDE
1 shared
Fresenius Kabi
Shared indications:
Local Anesthesia
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

Full development history with FDA approval milestones

|
Loading...
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.

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is indicated for the treatment of Simple dental procedures; Complex dental procedures; Local anesthesia; Infiltrative anesthesia; Conductive anesthesia.

Track EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

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