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Metaxalone 800 mg Tablet, 60-count — NDC 55700-0494-60 package photo

Metaxalone 800 mg Tablet, 60-count

by Quality Care Products, LLC · 60 TABLET in 1 BOTTLE (55700-494-60)
NDC 55700-0494-60
🏷️ FDA NDC (as labeled) 55700-494-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also comes in: 30 tablets 55700-0494-30 90 tablets 55700-0494-90
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 55700-494-60
Product NDC 55700-494
11-digit billing NDC 55700049460
NCPDP billing unit EA — each (per item)
RxCUI 351254
UNII 1NMA9J598Y
Application # ANDA204770
SPL Set ID f05bb280-6736-4215-be5b-0e5f7991cd87
Established class (EPC) Muscle Relaxant
Physiologic effect Centrally-mediated Muscle Relaxation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2016-11-22
Marketing end 2027-02-28
Route ORAL
Dosage form TABLET
Substance METAXALONE
GPI-14 75100060000320
GPI class Metaxalone
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 55700-494-60 — 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 → 55700-0494-60. 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.

🏭 Manufacturer & labeler

LabelerQuality Care Products, LLC
Application holderLANNETT CO INC
FDA applicationANDA204770 (ANDA)
Labeler code55700
First marketedNov 2016
Product typeHuman Prescription Drug
Portfolio70 products on file
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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Metaxalone, a muscle relaxant, is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Metaxalone is in a class of medications called skeletal muscle relaxants. It works by slowing activity in the nervous system to allow the body to relax.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Metaxalone is a muscle relaxant used to help ease pain and discomfort from short-term musculoskeletal conditions — things like muscle strains or injuries. It's not meant to be used...
  • Drowsiness is one of the most common side effects, yes. Dizziness, headache, and feeling irritable or nervous can also happen. You should not drive, operate heavy machinery, or do...
  • Will metaxalone make me too drowsy to function?
  • It does matter — and you should be consistent. Taking metaxalone with a high-fat meal significantly increases the amount of drug absorbed into your body compared to taking it on an...
📖 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.

💊 What it looks like

Color Pink
ShapeOval
ImprintLCI;1435
Size19 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

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

  • UNII 8C3Z4148WZ
    Alginic acid is a natural polymer extracted from brown seaweed. In medicines, it acts as a thickener, binder, and disintegrant to help form tablets and control how quickly the medicine dissolves.
  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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 ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets 90 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metaxalone 800 mg 00527-1435-01 Lannett 100 tablets $0.402 AB Availability likely —
Metaxalone 800 mg 00591-2341-01 Actavis 100 tablets $0.402 AB Availability likely —
Metaxalone 800 mg 00904-6831-04 Major 30 tablets $0.402 AB Availability likely —
Metaxalone 800 mg 50228-0323-01 ScieGen 100 tablets $0.402 AB Availability likely —
Metaxalone 800 mg 50268-0530-15 AvPAK 50 tablets $0.402 AB Availability likely —
Metaxalone 800 mg 55111-0650-01 Dr. 100 tablets $0.402 AB Availability likely —
Metaxalone 800 mg 60687-0663-21 American 30 tablets $0.402 AB Availability likely —
Metaxalone 800 mg 65162-0553-10 Amneal 100 tablets $0.402 AB Availability likely —
Metaxalone 800 mg 68001-0485-00 BluePoint 100 tablets $0.402 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 mgthis 55700-0494-60 Quality 60 tablets — AB Discontinued —
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

🏛️
2016
On the market since
Nov 2016
📍
2026
Currently FDA-listed
10 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Metaxalone — the ingredient across all brands.

Top reported reactions

Completed Suicide261
Nausea198
Pain198
Fatigue196
Headache172
Toxicity To Various Agents164
Fall160

Age at onset

Child2
Adult298
Elderly129

Reporter sex

3,328 reports
Male · 26%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization788
Death603
Life-threatening69
Disabling64
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 366 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55700-0494-30 30 TABLET in 1 BOTTLE (55700-494-30) 2017-02-10 Active
55700-0494-60 You're viewing this 60 TABLET in 1 BOTTLE (55700-494-60) 2017-02-10 Discontinued by firm
55700-0494-90 90 TABLET in 1 BOTTLE (55700-494-90) 2017-02-10 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 55700-0494-60?
NDC 55700-0494-60 is a 60-count package — 60 tablet in 1 bottle.
What is the difference between NDC 55700-0494-60 and NDC 55700-0494-30?
Both are Metaxalone 800 mg Tablet — the drug itself is identical. NDC 55700-0494-60 is the 60-count package, while NDC 55700-0494-30 is the 30 tablets package.
What NDC number is used to bill for this package of Metaxalone 800 mg Tablet?
Bill NDC 55700-0494-60 — the 11-digit billing format is 55700049460. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 55700-494-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55700-0494-60, written without dashes as 55700049460. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55700-0494-60, the first segment (55700) is the labeler code FDA assigned to Quality Care Products, LLC; the middle segment (0494) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (55700-0494-30), 90 tablets (55700-0494-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Quality Care Products, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🎯 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 12 words ▾

WARNINGS Metaxalone may enhance the effects of alcohol and other CNS depressants.

🤒 Adverse Reactions 50 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: hypersensitivity reaction, rash with or without pruritus; Hematologic: leukopenia; hemolytic anemia; Hepatobiliary: jaundice. Though rare, anaphylactoid reactions have been reported with metaxalone.

🔄 Drug Interactions 37 words ▾

Drug Interactions The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

🤰 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 88 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. When determining the LD 50 in rats and mice, progressive sedation, hypnosis, and finally respiratory failure were noted as the dosage increased. In dogs, no LD 50 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 1×400 mg tablet under fasted conditions (N=42) 2 Subjects received 2×400 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 18-50 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.

Mean (SD) Concentrations of Metaxalone following an 800 mg Dose under Fasted and Fed Conditions 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, C…

🧬 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 60 words ▾

HOW SUPPLIED Metaxalone Tablets, USP are available as 800 mg pink, capsule shaped, scored tablets, debossed “LCI” on one side and “14” bisect “35” on the other side. 55700-494-21 55700-494-30 55700-494-60 55700-494-90 Store at 20ºC to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 Made in the USA CIB71144B Rev. 05/16

📋 Description 103 words ▾

DESCRIPTION Metaxalone is available as an 800 mg pink, capsule shaped, scored 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: carboxymethylcellulose sodium, alginic acid, stearic acid, hydrogenated castor oil, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate, and FD&C Red #40 Aluminum Lake. metaxalone-struc

💬 Information for Patients 34 words ▾

Information for Patients 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.

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