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Metaxalone 800 mg Tablet, 50-count — NDC 50268-0530-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metaxalone 800 mg Tablet, 50-count — NDC 50268-530-15 (Billing 50268-0530-15)

by AvPAK · 50 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK

This is a package of 50 tablets of Metaxalone 800 mg Tablet from AvPAK, marketed since Mar 2015 and currently FDA-listed; retail pharmacies pay about $0.4524 per tablet (NADAC). It is this product's only package size.

NDC 50268-0530-15
🏷️ FDA NDC (as labeled) 50268-530-15 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 50268-530-15 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50268 labeler · 530 product · 15 package
Package marketed since
Mar 13, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
50 EA per package
Barcode (UPC-A, from the NDC)
3 5026853015 4
Medicaid fills, this package
24 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50268-530-15
Product NDC 50268-530
11-digit billing NDC 50268053015
NCPDP billing unit EA — each (per item)
RxCUI 351254
UNII 1NMA9J598Y
Application # ANDA203399
SPL Set ID 9b21a974-6a5a-9efb-e9de-470363217126
Established class (EPC) Muscle Relaxant
Physiologic effect Centrally-mediated Muscle Relaxation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-03-13
Route ORAL
Dosage form TABLET
Substance METAXALONE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 75100060000320
GPI class Metaxalone
GCN Seq No 051112
GCN 91765
HICL code 001945
Ingredient (HICL) Metaxalone
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.04.00
AHFS class Centrally Acting Skeletal Muscle Relaxnt
FDB label name METAXALONE 800 MG TABLET
FDB brand name Metaxalone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051112
  • GCN: 91765
  • GPI-14 (Medi-Span): 75100060000320
  • HICL (First Databank): 001945
  • AHFS class code: 12:20.04.00
  • RxCUI (RxNorm): 351254
Why two NDCs? The FDA registers this code as 50268-530-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50268-0530-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Muscle Relaxant class.

Pharmacologic class Muscle Relaxant
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name METAXALONE 800 MG TABLET Ingredient Metaxalone
📗 Our plain-language guide HelloPharmacist
  • It helps relieve discomfort from sudden, painful muscle and bone conditions. It is meant to be used along with rest and physical therapy, not by itself. It is for adults and teens...
  • Take it by mouth, with or without food, usually three to four times a day as your prescriber directs. Don't take more than prescribed. If you were on Skelaxin 800 mg, don't switch...
  • The most common are drowsiness, dizziness, headache, feeling nervous or irritable, nausea, vomiting and stomach upset. Be careful driving until you know how it affects you.
  • It's best to avoid it. Alcohol and other sedating medicines can add to the sleepiness and may slow your breathing.
📖 Read our full Metaxalone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.452 $22.62 / 50 tablet
Medicaid paysCMS SDUD · 12 mo $1.00 $50.23 / 50 tablet
Medicare drug plans payPart D · Q2 2026 $1.73 $86.54 / 50 tablet
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.664 $0.377
▼ Down 13% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50268-0530-15 You're viewing this Main listing 50 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK 2015-03-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metaxalone 800 mg 00527-1435-01 Lannett 100 tablets $0.452 AB Availability likely —
Metaxalone 800 mg 00591-2341-01 Actavis 100 tablets $0.452 AB Availability likely —
Metaxalone 800 mg 00904-6831-04 Major 30 tablets $0.452 AB Availability likely —
Metaxalone 800 mg 50228-0323-01 ScieGen 100 tablets $0.452 AB Availability likely —
Metaxalone 800 mgthis 50268-0530-15 AvPAK 50 tablets $0.452 AB Availability likely —
Metaxalone 800 mg 55111-0650-01 Dr. 100 tablets $0.452 AB Availability likely —
Metaxalone 800 mg 60687-0663-21 American 30 tablets $0.452 AB Availability likely —
Metaxalone 800 mg 65162-0553-10 Amneal 100 tablets $0.452 AB Availability likely —
Metaxalone 800 mg 68001-0485-00 BluePoint 100 tablets $0.452 AB Availability likely —
Metaxalone 800 mg 42291-0985-50 AvKARE 500 tablets — AB FDA listed —
Metaxalone 800 mg 50090-3650-00 A-S 30 tablets — AB FDA listed —
Metaxalone 800 mg 50090-3670-00 A-S 20 tablets — AB FDA listed —
Metaxalone 800 mg 51655-0171-20 Northwind 20 tablets — AB FDA listed —
Metaxalone 800 mg 51655-0792-20 Northwind 20 tablets — AB FDA listed —
Metaxalone 800 mg 53746-0553-01 Amneal 100 tablets — AB FDA listed —
Metaxalone 800 mg 55700-0494-30 Quality 30 tablets — AB FDA listed —
Metaxalone 800 mg 60760-0093-06 St. 6 tablets — AB Discontinued —
Metaxalone 800 mg 60760-0289-06 St. 6 tablets — AB FDA listed —
Metaxalone 800 mg 61919-0832-90 DIRECT 90 tablets — AB FDA listed —
Metaxalone 800 mg 63187-0490-10 Proficient 10 tablets — AB FDA listed —
Metaxalone 800 mg 63629-2097-01 Bryant 100 tablets — AB FDA listed —
Metaxalone 800 mg 63629-8014-01 Bryant 30 tablets — AB FDA listed —
Metaxalone 800 mg 68788-7675-00 Preferred 15 tablets — AB FDA listed —
Metaxalone 800 mg 68788-8678-01 Preferred 100 tablets — AB FDA listed —
Metaxalone 800 mg 69306-0100-01 Doc 100 tablets — AB FDA listed —
Metaxalone 800 mg 69306-0311-20 Doc 20 tablets — AB FDA listed —
Metaxalone 800 mg 70518-0771-00 REMEDYREPACK 90 tablets — AB FDA listed —
Metaxalone 800 mg 70518-4559-00 REMEDYREPACK 90 tablets — AB FDA listed —
Metaxalone 800 mg 71205-0016-10 Proficient 10 tablets — AB FDA listed —
Metaxalone 800 mg 71205-0326-20 Proficient 20 tablets — AB FDA listed —
Metaxalone 800 mg 71205-0426-14 Proficient 14 tablets — AB FDA listed —
Metaxalone 800 mg 71335-0375-00 Bryant 100 tablets — AB FDA listed —
Metaxalone 800 mg 71335-0958-00 Bryant 100 tablets — AB FDA listed —
Metaxalone 800 mg 71335-2066-01 Bryant 30 tablets — AB FDA listed —
Metaxalone 800 mg 72162-1083-01 Bryant 100 tablets — AB FDA listed —
Metaxalone 800 mg 72189-0645-30 Direct_Rx 30 tablets — AB FDA listed —
Metaxalone 800 mg 72789-0028-15 PD-Rx 15 tablets — AB FDA listed —
Metaxalone 800 mg 76420-0232-20 Asclemed 20 tablets — AB FDA listed —
Metaxalone 800 mg 76420-0898-01 Asclemed 100 tablets — AB FDA listed —
Metaxalone 800 mg 80425-0084-02 Advanced 60 tablets — AB FDA listed —
Metaxalone 800 mg 80425-0122-02 Advanced 60 tablets — AB FDA listed —
Metaxalone 800 mg 80425-0131-02 Advanced 60 tablets — AB FDA listed —
Metaxalone 800 mg 80425-0524-01 Advanced 30 tablets — AB FDA listed —
Metaxalone 800 mg 80425-0580-01 Advanced 30 tablets — AB FDA listed —
Metaxalone 800 mg 85509-1435-01 PHOENIX 120 tablets — AB FDA listed —
Metaxalone 800 mg 85509-2341-01 PHOENIX 100 tablets — AB FDA listed —
Metaxalone 800 mg 85766-0011-01 Sportpharm 100 tablets — AB FDA listed —
Metaxalone 800 mg 85766-0143-01 Sportpharm 100 tablets — AB FDA listed —
Metaxalone 800 mg 68788-4168-01 Preferred 100 tablets — AB FDA listed —
Metaxalone 800 mg 72789-0592-30 PD-Rx 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Mar 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Metaxalone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAvPAK
Application holderAMNEAL PHARMACEUTICALS
FDA applicationANDA203399 (ANDA)
Labeler code50268
First marketedMar 2015
Product typeHuman Prescription Drug
Portfolio350 products on file

More NDCs from AvPAK labeler code 50268

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

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. 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.

⏱️ Dosage and Administration 26 words ▾

DOSAGE AND ADMINISTRATION The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

⛔ Contraindications 24 words ▾

CONTRAINDICATIONS Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.

⚠️ Warnings ~1 min read ▾

WARNINGS Serotonin Syndrome Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range (see PRECAUTIONS: Drug Interactions) and with metaxalone as a single agent taken at doses higher than the recommended dose (see OVERDOSAGE). Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and drugs that impair metabolism of serotonin (including monoamine oxidase (MAO) inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (see PRECAUTIONS: Drug Interactions).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within several hours to a few days, but may occur later than that. Discontinue metaxalone if serotonin syndrome is suspected.

Risks from Concomitant Use with Alcohol or other CNS Depressants The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see PRECAUTIONS: Drug Interactions).

🤒 Adverse Reactions 108 words ▾

ADVERSE REACTIONS The most frequent reactions to metaxalone include: CNS : drowsiness, dizziness, headache, and nervousness or “irritability”; Digestive: nausea, vomiting, gastrointestinal upset. Other adverse reactions are: Immune System: anaphylaxis, hypersensitivity reaction, rash with or without pruritus; Hematologic : leukopenia; hemolytic anemia; Hepatobiliary : jaundice; CNS: cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range and with metaxalone as a single agent taken at doses higher than the recommended dose (see WARNINGS, PRECAUTIONS: Drug Interactions, and OVERDOSAGE).

To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 156 words ▾

Drug Interactions CNS Depressants The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see WARNINGS).

Serotonergic Drugs Serotonin syndrome has resulted from concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range (see WARNINGS). If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue metaxalone if serotonin syndrome is suspected.

Examples of serotonergic drugs include: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake 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 psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

🤰 Pregnancy 97 words ▾

Pregnancy Reproduction studies in rats have not revealed evidence of impaired fertility or harm to the fetus due to metaxalone. Post marketing experience has not revealed evidence of fetal injury, but such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus. Safe use of metaxalone has not been established with regard to possible adverse effects upon fetal development.

Therefore, metaxalone tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless, in the judgement of the physician, the potential benefits outweigh the possible hazards.

🧒 Pediatric Use 17 words ▾

Pediatric Use Safety and effectiveness in children 12 years of age and below have not been established.

🆘 Overdosage 107 words ▾

OVERDOSAGE Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with alcohol. Serotonin syndrome has been reported when metaxalone was used at doses higher than the recommended dose (see WARNINGS and ADVERSE REACTIONS). When determining the LD50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased.

In dogs, no LD50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes. Treatment - Gastric lavage and supportive therapy. Consultation with a regional poison control center is recommended.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. Pharmacokinetics The pharmacokinetics of metaxalone have been evaluated in healthy adult volunteers after single dose administration of metaxalone under fasted and fed conditions at doses ranging from 400 mg to 800 mg.

Absorption Peak plasma concentrations of metaxalone occur approximately 3 hours after a 400 mg oral dose under fasted conditions. Thereafter, metaxalone concentrations decline log-linearly with a terminal half-life of 9.0 ± 4.8 hours. Doubling the dose of metaxalone from 400 mg to 800 mg results in a roughly proportional increase in metaxalone exposure as indicated by peak plasma concentrations (C max ) and area under the curve (AUC).

Dose proportionality at doses above 800 mg has not been studied. The absolute bioavailability of metaxalone is not known. The single-dose pharmacokinetic parameters of metaxalone in two groups of healthy volunteers are shown in Table 1.

Table 1: Mean (%CV) Metaxalone Pharmacokinetic Parameters Dose (mg) C max (ng/mL) T max (h) AUC ∞ (ng•h/mL) t ½ (h) CL/F (L/h) 400 1 983 (53) 3.3 (35) 7479 (51) 9.0 (53) 68 (50) 800 2 1816 (43) 3.0 (39) 15044 (46) 8.0 (58) 66 (51) 1 Subjects received 1x400 mg tablet under fasted conditions (N=42) 2 Subjects received 2x400 mg tablets under fasted conditions (N=59) Food Effects A randomized, two-way, crossover study was conducted in 42 healthy volunteers (31 males, 11 females) administered one 400 mg metaxalone tablet under fasted conditions and following a standard high-fat breakfast.

Subjects ranged in age from 18 to 48 years (mean age = 23.5 ± 5.7 years). Compared to fasted conditions, the presence of a high fat meal at the time of drug administration increased C max by 177.5% and increased AUC (AUC 0-t , AUC ∞ ) by 123.5% and 115.4%, respectively. Time-to-peak concentration (T max ) was also delayed (4.3 h versus 3.3 h) and terminal half-life was decreased (2.4 h versus 9.0 h) under fed conditions compared to fasted.

In a second food effect study of similar design, two 400 mg metaxalone tablets (800 mg) were administered to healthy volunteers (N=59, 37 males, 22 females), ranging in age from 18 to 50 years (mean age = 25.6± 8.7 years). Compared to fasted conditions, the presence of a high fat meal at the time of drug administration increased C max by 193.6% and increased AUC (AUC 0-t , AUC ∞ ) by 146.4% and 142.2%, respectively. Time-to-peak concentration (T max ) was also delayed (4.9 h versus 3.0 h) and terminal half-life was decreased (4.2 h versus 8.0 h) under fed conditions compared to fasted conditions.

Similar food effect results were observed in the above study when one metaxalone 800 mg tablet was administered in place of two metaxalone 400 mg tablets. The increase in metaxalone exposure coinciding with a reduction in half-life may be attributed to more complete absorption of metaxalone in the presence of a high fat meal (Figure 1). figure 1 Distribution, Metabolism, and Excretion Although plasma protein binding and absolute bioavailability of metaxalone are not known, the apparent volume of distribution (V/F ~ 800 L) and lipophilicity (log P = 2.42) of metaxalone suggest that the drug is extensively distributed in the tissues.

Metaxalone is metabolized by the liver and excreted in the urine as unidentified metabolites. Hepatic Cytochrome P450 enzymes play a role in the metabolism of metaxalone. Specifically, CYP1A2, CYP2D6, CYP2E1, and CYP3A4 and, to a lesser extent, CYP2C8, CYP2C9, and CYP2C19 appear to metabolize metaxalone.

Metaxalone does not significantly inhibit major CYP enzymes such as CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4. Metaxalone does not significantly induce major CYP enzymes such as CYP1A2, CY… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 45 words ▾

Mechanism of Action The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

📦 How Supplied / Storage and Handling 105 words ▾

HOW SUPPLIED Metaxalone is available as an 800 mg , light pink to pink, capsule shaped, scored uncoated tablet with debossing ‘AN’ on the left side of the scoring and ‘553’ on the right side of the scoring. Other side of the tablet is plain. They are available as follows: NDC 50268-530-15 10 tablets per card, 5 cards per carton Dispensed in Blister Punch Material.

For Institutional Use Only. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: AvKARE Pulaski, TN 38478 Mfg.

Rev. 04-2018-03 AV Rev. 09/24 (A) AvPAK

📋 Description 107 words ▾

DESCRIPTION Metaxalone is available as an 800 mg, light pink to pink, capsule shaped, scored uncoated tablet. Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C 12 H 15 NO 3 , which corresponds to a molecular weight of 221.25.

The structural formula is: Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: calcium carbonate, FD&C Red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, silicone dioxide, sodium starch glycolate and sodium stearyl fumarate. chemical structure

💬 Information for Patients 120 words ▾

Information for Patients Driving or Operating Heavy Machinery Metaxalone may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with alcohol or other CNS depressants. Serotonin Syndrome Inform patients that metaxalone could cause a rare but potentially life-threatening condition resulting from administration of doses higher than the recommended dose or from concomitant administration of serotonergic drugs with metaxalone used within the recommended dosage range.

Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take, serotonergic medications (see WARNINGS, PRECAUTIONS: Drug Interactions, and OVERDOSAGE).

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Metaxalone should be administered with great care to patients with pre-existing liver damage. Serial liver function studies should be performed in these patients. False-positive Benedict’s tests, due to an unknown reducing substance, have been noted.

A glucose-specific test will differentiate findings. Taking metaxalone with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect. (See CLINICAL PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: Information for Patients section).

Information for Patients Driving or Operating Heavy Machinery Metaxalone may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with alcohol or other CNS depressants. Serotonin Syndrome Inform patients that metaxalone could cause a rare but potentially life-threatening condition resulting from administration of doses higher than the recommended dose or from concomitant administration of serotonergic drugs with metaxalone used within the recommended dosage range.

Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take, serotonergic medications (see WARNINGS, PRECAUTIONS: Drug Interactions, and OVERDOSAGE). Drug Interactions CNS Depressants The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive.

Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see WARNINGS). Serotonergic Drugs Serotonin syndrome has resulted from concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range (see WARNINGS).

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue metaxalone if serotonin syndrome is suspected. Examples of serotonergic drugs include: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake 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 psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of metaxalone has not been determined. Pregnancy Reproduction studies in rats have not revealed evidence of impaired fertility or harm to the fetus due to metaxalone. Post marketing experience has not revealed evidence of fetal injury, but such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus.

Safe use of metaxalone has not been established with regard to possible adverse effects upon fetal development. Therefore, metaxalone tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless, in the judgement of the physician, the potential benefits outweigh the possible hazards. Nursing Mothers It is not known whether this drug is secreted in human milk.

As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk. Pediatric Use Safety and effectiveness in children 12 years of age and below have not been established.

🍼 Nursing Mothers 38 words ▾

Nursing Mothers It is not known whether this drug is secreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics The pharmacokinetics of metaxalone have been evaluated in healthy adult volunteers after single dose administration of metaxalone under fasted and fed conditions at doses ranging from 400 mg to 800 mg.

Pharmacokinetics in Special Populations Age: The effects of age on the pharmacokinetics of metaxalone were determined following single administration of two 400 mg tablets (800 mg) under fasted and fed conditions. The results were analyzed separately, as well as in combination with the results from three other studies. Using the combined data, the results indicate that the pharmacokinetics of metaxalone are significantly more affected by age under fasted conditions than under fed conditions, with bioavailability under fasted conditions increasing with age.

The bioavailability of metaxalone under fasted and fed conditions in three groups of healthy volunteers of varying age is shown in Table 2. Table 2: Mean (%CV) Pharmacokinetic Parameters Following Single Administration of Two 400 mg Metaxalone Tablets (800 mg) under Fasted and Fed Conditions Younger Volunteers Older Volunteers Age (years) 25.6 ± 8.7 39.3 ± 10.8 71.5 ±

5.0N 59 21 23 Food Fasted Fed Fasted Fed Fasted Fed C max (ng/mL) 1816 (43) 3510 (41) 2719 (46) 2915 (55) 3168 (43) 3680 (59) T max (h) 3.0 (39) 4.9 (48) 3.0 (40) 8.7 (91) 2.6 (30) 6.5 (67) AUC 0-t (ng·h/mL) 14531 (47) 20683 (41) 19836 (40) 20482 (37) 23797 (45) 24340 (48) AUC ∞ (ng·h/mL) 15045 (46) 20833 (41) 20490 (39) 20815 (37) 24194 (44) 24704 (47) Gender: The effect of gender on the pharmacokinetics of metaxalone was assessed in an open label study, in which 48 healthy adult volunteers (24 males, 24 females) were administered two metaxalone 400 mg tablets (800 mg) under fasted conditions.

The bioavailability of metaxalone was significantly higher in females compared to males as evidenced by C max (2115 ng/mL versus 1335 ng/mL) and AUC ∞ (17884 ng·h/mL versus 10328 ng·h/mL). The mean half-life was 11.1 hours in females and 7.6 hours in males. The apparent volume of distribution of metaxalone was approximately 22% higher in males than in females, but not significantly different when adjusted for body weight.

Similar findings were also seen when the previously described combined dataset was used in the analysis. Hepatic/Renal Insufficiency: The impact of hepatic and renal disease on the pharmacokinetics of metaxalone has not been determined. In the absence of such information, metaxalone should be used with caution in patients with hepatic and/or renal impairment.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of metaxalone has not been determined.

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q2 2025 – Q4 2025 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
24
Units reimbursed last 4 qtrs
78
Gross reimbursed last 4 qtrs
$78.35
Avg / prescription
$3.26
Avg / unit
$1.0045
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$1.0045
gross reimbursed
vs
NADAC / ea
$0.4524
acquisition cost
=
Spread
+$0.5521
+122% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 24 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 78 units · 1.7 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.71.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 1.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Metaxalone — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Metaxalone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.81M
Claims incl. refills
18.6K
Beneficiaries
13K
Spend / beneficiary
$138.82
Spend / claim
$97.57
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 50268-0529-15 · AvPAK 50268-0534-15 · AvPAK →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.