Orange Book product · Brand (NDA)

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NOREPINEPHRINE BITARTRATE

Brand (NDA)NDA 215700RX INFORLIFE

Sep 15, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 15, 2022
3 yr 10 mo ago
Today
Patent RE49422 expires
Listed drug product patent expiration.
Feb 26, 2035
in 8 yr 10 mo
Patent 10888534 expires
Listed drug product patent expiration.
Apr 26, 2039
in 13 yr

Active ingredient

NOREPINEPHRINE BITARTRATE

Strength

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

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 215700

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
RE49422	Feb 26, 2035	in 8 yr 10 mo	Product
10888534	Apr 26, 2039	in 13 yr	Product