Quick answers
- What is Cyclobenzaprine hydrochloride used for?
- The FDA-approved label (Amrix, Cephalon, LLC, April 30, 2024) says: “AMRIX ® (cyclobenzaprine hydrochloride extended-release capsules) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cyclobenzaprine hydrochloride have a boxed warning?
- No. None of the 182 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cyclobenzaprine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cyclobenzaprine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 27, 2025 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Cyclobenzaprine hydrochloride?
- 58 companies list prescription products of Cyclobenzaprine hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc. and NuCare Pharmaceuticals, Inc..
What Cyclobenzaprine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AMRIX ® (cyclobenzaprine hydrochloride extended-release capsules) is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use …
— FDA label: Amrix, Cephalon, LLC, effective April 30, 2024. Read the full label on DailyMed →
The FDA has 182 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 182 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| cyclobenzaprine hydrochloride 10 mg tablet | Generic | $0.0172 per tablet |
| cyclobenzaprine hydrochloride 10 mg tablet, film coated | Generic | $0.0172 per tablet |
| cyclobenzaprine hydrochloride 15 mg capsule, extended release | Generic | $1.18 per capsule |
| cyclobenzaprine hydrochloride 15 mg capsule, extended release | Brand: Amrix | $66.23 per capsule |
| cyclobenzaprine hydrochloride 2.8 mg tablet, orally disintegrating | Brand: Tonmya | $29.59 per tablet |
| cyclobenzaprine hydrochloride 30 mg capsule, extended release | Generic | $1.47 per capsule |
| cyclobenzaprine hydrochloride 30 mg capsule, extended release | Brand: Amrix | $66.57 per capsule |
| cyclobenzaprine hydrochloride 5 mg tablet | Generic | $0.0222 per tablet |
| cyclobenzaprine hydrochloride 5 mg tablet, film coated | Generic | $0.0222 per tablet |
| cyclobenzaprine hydrochloride 7.5 mg tablet | Generic | $0.2928 per tablet |
| cyclobenzaprine hydrochloride 7.5 mg tablet, film coated | Generic | $0.2928 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack21 products
- Asclemed USA, Inc.18 products
- NuCare Pharmaceuticals, Inc.17 products
- Remedyrepack Inc.15 products
- Proficient Rx LP12 products
- A-S Medication Solutions11 products
- Preferred Pharmaceuticals Inc.10 products
- Advanced Rx of Tennessee, LLC9 products
- Direct_Rx7 products
- PD-Rx Pharmaceuticals, Inc.7 products
- Northwind Health Company, LLC6 products
- Teva Pharmaceuticals USA, Inc.5 products
- Phoenix RX LLC5 products
- Sportpharm LLC5 products
- Rising Pharma Holdings, Inc.5 products
- Aphena Pharma Solutions - Tennessee, LLC4 products
- Amneal Pharmaceuticals of New York LLC4 products
- Redpharm Drug4 products
- NorthStar Rx LLC3 products
- Advagen Pharma Limited3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Coupler LLC3 products
- Hawaii Repack, Inc.3 products
- Unichem Pharmaceuticals (USA), Inc.3 products
- TruPharma, LLC3 products
- Alembic Pharmaceuticals Inc.3 products
- AiPing Pharmaceutical, Inc.3 products
- Jubilant Cadista Pharmaceuticals Inc.3 products
- St. Mary's Medical Park Pharmacy3 products
- DirectRx2 products
- Medcore LLC2 products
- Aurobindo Pharma Limited2 products
- Cipla USA Inc.2 products
- AvPAK2 products
- Doc Rx2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Amneal Pharmaceuticals LLC2 products
- American Health Packaging2 products
- QPharma, Inc.2 products
- Major Pharmaceuticals2 products
- KVK-Tech, Inc.2 products
- Upsher-Smith Laboratories, LLC2 products
- Solco Healthcare U.S., LLC2 products
- Cephalon, LLC2 products
- Macleods Pharmaceuticals Limited2 products
- Tonix Medicines, Inc.1 product
- Quality Care Products, LLC1 product
- RedPharm Drug, Inc.1 product
- Unit Dose Solutions, Inc.1 product
- Medsource Pharmaceuticals1 product
- SA3, LLC1 product
- Exelan Pharmaceuticals Inc.1 product
- Cardinal Health 107, LLC1 product
- Golden State Medical Supply, Inc.1 product
- NuCare Pharmaceutuicals, Inc.1 product
- SOLA Pharmaceuticals, LLC1 product
- AvKARE1 product
- Coral Way Pharma, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021777 AMRIX | Teva Pharms Intl | February 1, 2007 | 8, latest April 25, 2024 2024: Labeling · 2019: Labeling · 2016: Labeling |
| NDA219428 TONMYA | Tonix | August 15, 2025 | — |
Generic approvals (14)
- ANDA071611Actavis Labs Fl Inc · February 29, 1988
- ANDA072854Aiping Pharm Inc · November 19, 1991
- ANDA077563Jubilant Cadista · April 19, 2006
- ANDA077797Prinston Inc · February 28, 2007
- ANDA078218Chartwell Rx · April 18, 2008
- ANDA078722Sun Pharm Inds Ltd · May 12, 2008
- ANDA078643Aurobindo Pharma · September 26, 2008
- ANDA090478Invagen Pharms · July 23, 2010
- ANDA078048Kvk Tech · February 28, 2011
- ANDA091281Twi Pharms Inc · January 31, 2013
- ANDA208170Rubicon Research · May 31, 2017
- ANDA213324Unichem · July 6, 2020
- ANDA207314Macleods Pharms · July 22, 2024
- ANDA218936Rising · September 12, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 27, 2025 · Class I · Ongoing · D-0655-2025
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), — Unichem Pharmaceuticals USA Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amrix, Cephalon, LLC, effective April 30, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →