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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 071611 | ACTAVIS LABS FL INC | 1988-02-29 | 7 |
| ANDA 077563 | JUBILANT CADISTA | 2006-04-19 | 14 |
| NDA 021777 | TEVA PHARMS INTL | 2007-02-01 | 17 |
| ANDA 077797 | PRINSTON INC | 2007-02-28 | 16 |
| ANDA 078218 | CHARTWELL RX | 2008-04-18 | 8 |
| ANDA 078722 | SUN PHARM INDS LTD | 2008-05-12 | 10 |
| ANDA 078643 | AUROBINDO PHARMA | 2008-09-26 | 23 |
| ANDA 090478 | INVAGEN PHARMS | 2010-07-23 | 12 |
| ANDA 078048 | KVK TECH | 2011-02-28 | 6 |
| ANDA 091281 | TWI PHARMS INC | 2013-01-31 | 14 |
| ANDA 208170 | RUBICON RESEARCH | 2017-05-31 | 71 |
| ANDA 213324 | UNICHEM | 2020-07-06 | 31 |
| ANDA 207314 | MACLEODS PHARMS | 2024-07-22 | 2 |
| ANDA 218936 | RISING | 2024-09-12 | 6 |
| NDA 219428 | TONIX | 2025-08-15 | 1 |
Official labeling on DailyMed
- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SPORTPHARM LLC] · version 1 · 2026-09-11
- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 14 · 2026-09-10
- CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 2 · 2026-09-07
- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] · version 5 · 2026-09-07
- CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-03
- AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CEPHALON, LLC] · version 32 · 2026-09-02
- CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] · version 4 · 2026-09-02
- CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] · version 3 · 2026-09-02
- CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.] · version 15 · 2026-09-02
- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] · version 7 · 2026-09-02
- CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] · version 3 · 2026-08-31
- CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX] · version 6 · 2026-08-31
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.