Quick answers
- What is Metaxalone used for?
- The FDA-approved label (Metaxalone, INA Pharmaceutics Inc, February 3, 2026) says: “Metaxalone Tablets, 640 mg, are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Metaxalone have a boxed warning?
- No. None of the 58 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Metaxalone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Metaxalone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Metaxalone?
- 33 companies list prescription products of Metaxalone in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and Direct_Rx.
What Metaxalone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Metaxalone Tablets, 640 mg, are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. …
— FDA label: Metaxalone, INA Pharmaceutics Inc, effective February 3, 2026. Read the full label on DailyMed →
The FDA has 58 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 58 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 59 in the FDA NDC Directory |
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 |
|---|---|---|
| metaxalone 400 mg tablet | Generic | $2.49 per tablet |
| metaxalone 800 mg tablet | Generic | $0.4682 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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 Prepack6 products
- Proficient Rx LP5 products
- Direct_Rx5 products
- Preferred Pharmaceuticals Inc.3 products
- Advanced Rx of Tennessee, LLC3 products
- AvKARE2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Northwind Health Company, LLC2 products
- St. Mary's Medical Park Pharmacy2 products
- Asclemed USA, Inc.2 products
- ScieGen Pharmaceuticals, Inc.2 products
- Doc Rx2 products
- A-S Medication Solutions2 products
- Phoenix RX LLC2 products
- Sportpharm LLC2 products
- Remedyrepack Inc.2 products
- Amneal Pharmaceuticals of New York LLC2 products
- AvPAK1 product
- Quality Care Products, LLC1 product
- Redpharm Drug1 product
- Cipla USA Inc.1 product
- Actavis Pharma, Inc.1 product
- American Health Packaging1 product
- Lannett Company, Inc.1 product
- Highmark Pharma LLC1 product
- BluePoint Laboratories1 product
- Dr. Reddys Laboratories Limited1 product
- Misemer Pharmaceuticals, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Blue Heron Pharmaceuticals, LLC1 product
- Major Pharmaceuticals1 product
- INA Pharmaceutics Inc1 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 |
|---|---|---|---|
| NDA022503 METAXALONE | Primus Pharms | June 1, 2015 | 3, latest May 8, 2025 2025: Labeling · 2024: Labeling · 2022: Labeling |
Generic approvals (5)
- ANDA203399Amneal Pharms · June 21, 2013
- ANDA040486Mountain · February 27, 2015
- ANDA204770Lannett Co Inc · November 22, 2016
- ANDA203695Actavis Labs Fl Inc · June 15, 2017
- ANDA207466Sciegen Pharms · August 31, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 197935, 351254, 2627781 |
|---|---|
| SPL set ID of the quoted label | fc6de1a6-26aa-47ac-a5d2-bf127a6ca563 |
| FDA labels (SPL) | 58 |
| FDA applications | NDA022503, 5 ANDA |
| Active ingredients (FDA) | METAXALONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Metaxalone, INA Pharmaceutics Inc, effective February 3, 2026; 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 →