Prescription medicine
Metaxalone First approved as Skelaxin
Metaxalone (Skelaxin) is a prescription medicine with an FDA approval on record since 1962. FDA's NDC Directory lists it from 33 generic labelers, and pharmacies paid $0.452 per metaxalone 800 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the metaxalone FDA label on DailyMed (effective January 11, 2023, Amneal Pharmaceuticals of New York LLC); the NDA 13217 record on Drugs@FDA; every metaxalone label on DailyMed.
Highlights of the record
FDA label of January 11, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMetaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.
Forms and strengths
- 400 mg
- 640 mg
- 800 mg
Tablet.
On the market
- Earliest approval on file
- August 13, 1962 Skelaxin, King Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first March 31, 2010; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 34 of which 33 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 6, 2026 Skelaxin tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.452 per tablet Metaxalone 800 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 3,327 through July 30, 2026
What is metaxalone used for?
From the label: indications and usageMetaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
Conditions named in the indications of metaxalone's FDA labels, with every medicine labeled for each:
From other metaxalone labelsMuscle spasms and spasticity: INDICATIONS AND USAGE Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.
FDA pharmacologic class: Muscle Relaxant.
Source: FDA drug label (Metaxalone), Amneal Pharmaceuticals of New York LLC, effective January 11, 2023 (SPL set f06f2b96-3684-483c-89f7-6c9201fd4664), via openFDA; the full label on DailyMed
Is there a generic for metaxalone (Skelaxin)?
The FDA approved the first generic metaxalone on March 31, 2010. 8 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists metaxalone from 33 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Skelaxin tablets, the last expiring on February 6, 2026; a patent listed only for Metaxalone tablets runs to May 14, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1962 earliest approval on file
- 2010 first generic approved
- 2026 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 metaxalone (Skelaxin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.452 per Metaxalone 800 mg tablet, down 3% from $0.467 on October 8, 2025. 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.
- Metaxalone 800 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Metaxalone 400 mg tablet | Generic | $2.59 per tablet | $77.79 | -8% |
| Metaxalone 800 mg tablet | Generic | $0.452 per tablet | $13.57 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has metaxalone been recalled?
The FDA's Enforcement Report lists 1 recall naming metaxalone since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of metaxalone 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 |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the metaxalone label say about other medicines?
The metaxalone label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 29 other medicines name metaxalone. 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 |
|---|---|---|
| Fentanyl | drug interactions | … inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat … |
| Linezolid | drug interactions | … monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Meperidine | drug interactions | … (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric … |
| Methadone | drug interactions | … antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others … |
| Methylene blue | drug interactions | … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Mirtazapine | drug interactions | … (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Tramadol | drug interactions | … meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Trazodone | drug interactions | … fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
Other labels that name metaxalone
Source: FDA drug label (Metaxalone), Amneal Pharmaceuticals of New York LLC, effective January 11, 2023 (SPL set f06f2b96-3684-483c-89f7-6c9201fd4664), via openFDA; the full label on DailyMed
What do FAERS reports show for metaxalone?
The FDA Adverse Event Reporting System holds 3,327 reports that list metaxalone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 603 are coded as a death and 787 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 metaxalone?
9 other medicines are given the same way (oral) and in the same FDA class as metaxalone 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 |
|---|---|---|---|---|
| Cyclobenzaprine | Muscle spasms and spasticity | 60 labelers | $0.0171 per tablet 10 mg tablet | No current entry |
| Methocarbamol | Muscle spasms and spasticity | 54 labelers | $0.0395 per tablet 500 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 metaxalone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does metaxalone compare with medicines for the same use?
5 side-by-side pages set metaxalone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to metaxalone
- 9 medicines for the same use
- Other muscle relaxants
- the pharmacologic class, with prices and generics
- Metaxalone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other