Orange Book product · Brand (NDA)

KHINDIVI

HYDROCORTISONE

Brand (NDA)NDA 218980RX ETON

May 28, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 28, 2025
1 yr 1 mo ago
Today
Patent 11904046 expires
Listed drug product patent expiration.
Feb 23, 2043
in 16 yr 11 mo
Patent 12133914 expires
Listed method-of-use patent (U-4215) expiration.
Feb 23, 2043
in 16 yr 11 mo

Active ingredient

HYDROCORTISONE

Strength

1MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 218980

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
11904046	Feb 23, 2043	in 16 yr 11 mo	ProductU-4216
12133914	Feb 23, 2043	in 16 yr 11 mo	U-4215