Is TIZANIDINE HYDROCHLORIDE FDA approved?

TIZANIDINE HYDROCHLORIDE holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does TIZANIDINE HYDROCHLORIDE make?

1 product is listed under TIZANIDINE HYDROCHLORIDE in the openFDA NDC Directory, most often as tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

TIZANIDINE HYDROCHLORIDE

Data as of 24 Sept 2026 · How to read this entry

Request a quote Claim this profile

Registered sites: 0
Active NDC listings: 1
Live patents: 0
Countries: 0

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	tablet, oral	61919-196ANDA

Compare

Other companies listing tizanidine hydrochloride

Viyash Scientific Limited9 sites · 58 NDC
Nivagen Pharmaceuticals LLC2 sites · 106 NDC
Professional Compounding Centers of America dba PCCA1 site · 487 NDC
Mylan Pharmaceuticals, Inc.0 sites · 489 NDC

Enquiry

Common questions

Is TIZANIDINE HYDROCHLORIDE FDA approved?: TIZANIDINE HYDROCHLORIDE holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does TIZANIDINE HYDROCHLORIDE make?: 1 product is listed under TIZANIDINE HYDROCHLORIDE in the openFDA NDC Directory, most often as tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.