Orange Book product · Brand (NDA)

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

EPINEPHRINE BITARTRATE

Brand (NDA)NDA 218475RX BAXTER HLTHCARE CORP

View EPINEPHRINE BITARTRATE family Open on FDA Orange Book

At a glance

Mar 16, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Mar 16, 2026
3 mo ago
Today

Pharmaceutical detail

Active ingredient

EPINEPHRINE BITARTRATE

Strength

EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 218475

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo