Orange Book product · Brand (NDA)

EPINEPHRINE

Brand (NDA)NDA 215425RX FRESENIUS KABI USA

Mar 13, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 13, 2025
1 yr 3 mo ago
Today
Patent 12539283 expires
Listed drug product patent expiration.
Jan 17, 2045
in 18 yr 10 mo

Active ingredient

EPINEPHRINE

Strength

30MG/30ML (1MG/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

TE code

Not listed

Application

NDA 215425

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12539283	Jan 17, 2045	in 18 yr 10 mo	Product