Orange Book product · Brand (NDA)

PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

PHENYLEPHRINE HYDROCHLORIDE

Brand (NDA)NDA 216830RX DR REDDYS LABS SA

May 30, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 30, 2025
1 yr 1 mo ago
Today
Patent 12564561 expires
Listed drug product patent expiration.
Aug 08, 2044
in 18 yr 5 mo

Active ingredient

PHENYLEPHRINE HYDROCHLORIDE

Strength

20MG/250ML (0.08MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216830

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
12564561	Aug 08, 2044	in 18 yr 5 mo	Product