Prescription medicine
Cyclobenzaprine Brand names: Amrix, Tonmya, Fexmid; first approved as Flexeril
Cyclobenzaprine (Flexeril) is a prescription medicine with an FDA approval on record since 1977. FDA's NDC Directory lists it from 59 generic labelers, and pharmacies paid $0.0171 per cyclobenzaprine 10 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $29.61 per tablet (Tonmya 2.8 mg tablet sl).
- Generic listed
Check it at the source: the cyclobenzaprine FDA label on DailyMed (effective February 21, 2025, Jubilant Cadista Pharmaceuticals Inc.); the NDA 17821 record on Drugs@FDA; every cyclobenzaprine label on DailyMed.
Highlights of the record
FDA label of February 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Forms and strengths
- 2.8 mg
- 5 mg
- 7.5 mg
- 10 mg
- 15 mg
- 30 mg
Film-coated tablet; extended-release capsule; tablet; orally disintegrating tablet.
On the market
- Earliest approval on file
- August 26, 1977 Flexeril, Janssen Res And Dev; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first February 29, 1988; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 61 of which 59 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- March 14, 2034 Tonmya tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0171 per tablet Cyclobenzaprine 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 1 Class I among all firms' recalls; latest August 27, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 50,442 through July 30, 2026
What is cyclobenzaprine used for?
From the label: indications and usageCyclobenzaprine hydrochloride tablets, USP are 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, limitation of motion, and restriction in activities of daily living. […]
Conditions named in the indications of cyclobenzaprine's FDA labels, with every medicine labeled for each:
From other cyclobenzaprine labelsMuscle spasms and spasticity: INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Nerve pain and fibromyalgia: TONMYA ® is indicated for treatment of fibromyalgia in adults.
FDA pharmacologic class: Muscle Relaxant.
Source: FDA drug label (Cyclobenzaprine Hydrochloride), Jubilant Cadista Pharmaceuticals Inc., effective February 21, 2025 (SPL set 592871f6-0eb2-4624-9e10-bd8bf767c002), via openFDA; the full label on DailyMed
What does the patient leaflet for cyclobenzaprine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking cyclobenzaprine hydrochloride extended-release capsules?You should not drink alcohol until you know how cyclobenzaprine hydrochloride extended-release capsules affect you. Taking cyclobenzaprine hydrochloride extended-release capsules with alcohol or other medicines that depress your central nervous system can slow your thinking and physical response times. Do not drive, operate machinery, or do other dangerous activities until you know how cyclobenzaprine hydrochloride extended-release capsules affect you.
From the patient leaflet: How should I store cyclobenzaprine hydrochloride extended-release capsules?Store cyclobenzaprine hydrochloride extended-release capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep cyclobenzaprine hydrochloride extended-release capsules in a tightly closed container, and keep cyclobenzaprine hydrochloride extended-release capsules out of light. Keep cyclobenzaprine hydrochloride extended-release capsules and all medicines out of the reach of children.
Source: FDA drug label (Cyclobenzaprine Hydrochloride), Teva Pharmaceuticals USA, Inc., effective May 31, 2024 (SPL set ca74d27a-f7c6-462d-a913-1cfa061bd8f3), via openFDA; the full label on DailyMed
Is there a generic for cyclobenzaprine (Flexeril)?
The FDA approved the first generic cyclobenzaprine on February 29, 1988. 23 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists cyclobenzaprine from 59 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Flexeril tablets; a patent listed only for Tonmya tablets runs to March 14, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1977 earliest approval on file
- 1988 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cyclobenzaprine (Flexeril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0171 per Cyclobenzaprine 10 mg tablet, down 10% from $0.019 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cyclobenzaprine 10 mg tablet (generic)
- Tonmya 2.8 mg tablet sl (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cyclobenzaprine 10 mg tablet | Generic | $0.0171 per tablet | $0.514 | -10% |
| Cyclobenzaprine 5 mg tablet | Generic | $0.022 per tablet | $0.659 | +2% |
| Cyclobenzaprine 7.5 mg tablet | Generic | $0.263 per tablet | $7.89 | -19% |
| Cyclobenzaprine ER 15 mg capsule | Generic | $1.19 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $35.57 | +0.1% |
| Cyclobenzaprine ER 30 mg capsule | Generic | $1.08 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $32.47 | -61% |
| Fexmid 7.5 mg tablet | Generic | $0.263 per tablet | $7.89 | -17% |
| Amrix ER 15 mg capsule | Brand | $66.23 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $1,986.98 | +9% |
| Amrix ER 30 mg capsule | Brand | $66.57 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $1,997.01 | +9% |
| Tonmya 2.8 mg tablet sl | Brand | $29.61 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $888.29 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cyclobenzaprine been recalled?
The FDA's Enforcement Report lists 6 recalls naming cyclobenzaprine since 2013: 1 Class I (the most serious), 5 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of cyclobenzaprine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 27, 2025 | Class I | Unichem Pharmaceuticals USA Inc. | 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 … |
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch … |
| June 19, 2017 | Class II | Apace KY LLC | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cyclobenzaprine label say about other medicines?
The cyclobenzaprine label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 35 other medicines name cyclobenzaprine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amitriptyline | warnings | Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. |
| Bupropion | warnings | … (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. |
| Imipramine | warnings | Cyclobenzaprine is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. |
| Meperidine | warnings | … serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. |
| Tramadol | warnings | … inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. |
| Verapamil | warnings | … norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. |
Other labels that name cyclobenzaprine
Source: FDA drug label (Cyclobenzaprine Hydrochloride), Jubilant Cadista Pharmaceuticals Inc., effective February 21, 2025 (SPL set 592871f6-0eb2-4624-9e10-bd8bf767c002), via openFDA; the full label on DailyMed
What do FAERS reports show for cyclobenzaprine?
The FDA Adverse Event Reporting System holds 50,442 reports that list cyclobenzaprine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,185 are coded as a death and 14,099 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cyclobenzaprine?
9 other medicines are given the same way (oral) and in the same FDA class as cyclobenzaprine or labeled mainly for the same use (muscle spasms and spasticity), the same class first. Muscle spasms and spasticity lists all 12 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Methocarbamol | Muscle spasms and spasticity | 54 labelers | $0.0395 per tablet 500 mg tablet | No current entry |
| Metaxalone | Muscle spasms and spasticity | 33 labelers | $0.452 per tablet 800 mg tablet | No current entry |
| Carisoprodol | Muscle spasms and spasticity | 24 labelers | $0.0706 per tablet 350 mg tablet | No current entry |
| Chlorzoxazone | Muscle spasms and spasticity | 19 labelers | $0.210 per tablet 500 mg tablet | No current entry |
| Orphenadrine | Muscle spasms and spasticity | 14 labelers | $0.454 per tablet 100 mg tablet | No current entry |
| Aspirin and caffeine and orphenadrine | Muscle spasms and spasticity | 3 labelers | n/a | No current entry |
| Baclofen | Muscle spasms and spasticity | 52 labelers | $0.032 per tablet 10 mg tablet | No current entry |
| Tizanidine | Muscle spasms and spasticity | 51 labelers | $0.0331 per tablet 4 mg tablet | No current entry |
Every medicine labeled for the same conditions as cyclobenzaprine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cyclobenzaprine compare with medicines for the same use?
10 side-by-side pages set cyclobenzaprine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cyclobenzaprine
- 9 medicines for the same use
- Other muscle relaxants
- the pharmacologic class, with prices and generics
- Cyclobenzaprine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other