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Active ingredient

Cyclobenzaprine

238 finished FDA listings contain Cyclobenzaprine as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
CYCLOBENZAPRINE HYDROCHLORIDE
Dosage forms
Capsule, Extended Release, Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Oral, Sublingual
Manufacturers / labelers
61
Strengths listed
10 mg/1 · 15 mg/1 · 2.8 mg/1 · 30 mg/1 · 5 mg/1 · 7.5 mg/1
Brand names in FDA listings
Amrix, Cyclobenzaprine Hcl Er, Cyclobenzaprine Hydrochloride, Fexmid, Tonmya

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 21949

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
ANDA 071611ACTAVIS LABS FL INC1988-02-297
ANDA 077563JUBILANT CADISTA2006-04-1914
NDA 021777TEVA PHARMS INTL2007-02-0117
ANDA 077797PRINSTON INC2007-02-2816
ANDA 078218CHARTWELL RX2008-04-188
ANDA 078722SUN PHARM INDS LTD2008-05-1210
ANDA 078643AUROBINDO PHARMA2008-09-2623
ANDA 090478INVAGEN PHARMS2010-07-2312
ANDA 078048KVK TECH2011-02-286
ANDA 091281TWI PHARMS INC2013-01-3114
ANDA 208170RUBICON RESEARCH2017-05-3171
ANDA 213324UNICHEM2020-07-0631
ANDA 207314MACLEODS PHARMS2024-07-222
ANDA 218936RISING2024-09-126
NDA 219428TONIX2025-08-151

Official labeling on DailyMed

Showing the 12 most recent of 192 labels.

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