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Active ingredient

Tizanidine

199 finished FDA listings contain Tizanidine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TIZANIDINE HYDROCHLORIDE
Dosage forms
Capsule, Capsule, Gelatin Coated, Solution, Tablet
Routes
Oral
Manufacturers / labelers
55
Strengths listed
2 mg/1 · 2 mg/5ml · 4 mg/1 · 6 mg/1 · 8 mg/1
Brand names in FDA listings
Ontralfy, Zanaflex

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 57258

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020397LEGACY1996-11-272
ANDA 076286DR REDDYS LABS INC2002-07-0341
NDA 021447LEGACY2002-08-299
ANDA 076416SUN PHARM INDS INC2003-09-2925
ANDA 076282AUROBINDO PHARMA USA2003-12-162
ANDA 076533APOTEX2004-01-168
ANDA 078868APOTEX INC2012-02-034
ANDA 091283UNICHEM LABS LTD2012-11-2819
ANDA 208622ZYDUS PHARMS2017-03-036
ANDA 208187CADILA2018-03-0915
ANDA 211798ALKEM LABS LTD2019-01-252
ANDA 210267INGENUS PHARMS LLC2019-03-1210
ANDA 210021CADILA PHARMS LTD2019-03-269
ANDA 212196ALKEM LABS LTD2019-03-2719
ANDA 213223ALEMBIC2020-01-136
ANDA 213544AUROBINDO PHARMA LTD2020-03-243
ANDA 213798RUBICON RESEARCH2020-05-2714
ANDA 218920RISING2024-08-074
NDA 216190FIDELITY BIOPHARMA2024-12-121

Official labeling on DailyMed

Showing the 12 most recent of 135 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.