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Metaxalone 800 mg Tablet, 500-count

by Lannett Company, Inc. · 500 TABLET in 1 BOTTLE (0527-1435-05)

NDC 00527-1435-05

🏷️ FDA NDC (as labeled) 0527-1435-05 billing pads the labeler segment with a zero

This package

Contains500-count Pack sizes2 compare ↓

Also priced by: Part D plans $1.73/unit — full pricing hub ↓

Also comes in: 100 tablets 00527-1435-01

Rx only Generic On market Non-controlled

🗂️ 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 0527-1435-05

Product NDC 0527-1435

11-digit billing NDC 00527143505

RxCUI 351254

UNII 1NMA9J598Y

UPC 0305271435019

Application # ANDA204770

SPL Set ID 8294bb3c-c8eb-474c-b567-e53cf81249e9

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 2016-11-22

Route ORAL

Dosage form TABLET

Substance METAXALONE

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

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 0527-1435-05 — a 4-4-2 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 labeler segment → 00527-1435-05. 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

LabelerLannett Company, Inc.

Application holderLANNETT CO INC

FDA applicationANDA204770 (ANDA)

Labeler code00527

First marketedNov 2016

Product typeHuman Prescription Drug

Portfolio171 products on file

🔎 All NDCs from Lannett Company, Inc.

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

Label name METAXALONE 800 MG TABLET Ingredient Metaxalone

📖 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Metaxalone — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Metaxalone (20 interactions) — ranked by severity →

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 system	Per each	Per 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 · Q2 2026	$1.73	$865.35 / 500 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
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 mgthis 00527-1435-05	Lannett	500 tablets	—	AB	FDA listed	—
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

🏛️

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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

100 tablets00527-1435-01 12,193 Rx · $554,451

500 tablets this page00527-1435-05 No Medicaid data

Drug total (last 4 qtrs): 12,193 Rx · 804,461 units · $554,451 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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

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

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 NDC	Description	Per unit	Per pack	Marketing start	Status
00527-1435-01	100 TABLET in 1 BOTTLE (0527-1435-01)	$0.4018 / ea	$40.18	2016-11-22	Active
00527-1435-05 You're viewing this	500 TABLET in 1 BOTTLE (0527-1435-05)	—	—	2016-11-22	Active

You're viewing the largest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00527-1435-05?

NDC 00527-1435-05 is a 500-count package — 500 tablet in 1 bottle.

What is the difference between NDC 00527-1435-05 and NDC 00527-1435-01?

Both are Metaxalone 800 mg Tablet — the drug itself is identical. NDC 00527-1435-05 is the 500-count package, while NDC 00527-1435-01 is the 100 tablets package.

What NDC number is used to bill for this package of Metaxalone 800 mg Tablet?

Bill NDC 00527-1435-05 — the 11-digit billing format is 00527143505. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product

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.

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 0527-1435-05, 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: 00527-1435-05, written without dashes as 00527143505. 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 00527-1435-05, the first segment (00527) is the labeler code FDA assigned to Lannett Company, Inc.; the middle segment (1435) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lannett Company, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (00527-1435-01). 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?

Lannett Company, Inc. 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 80 words ▾

1 INDICATIONS AND USAGE Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. Metaxalone is a muscle relaxant 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. ( 1 )

⏱️ Dosage and Administration 217 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of metaxalone in adults and pediatric patients 13 years of age and older is 800 mg orally three to four times a day [see Use in Specific Populations ( 8 )] . Metaxalone Tablets 800 mg are not substitutable on a mg to mg basis with Metaxalone Tablets, 640 mg [see Clinical Pharmacology ( 12.3 )] . When it is appropriate to switch: Switch only in patients who have been taking Metaxalone Tablets, 640 mg on an empty stomach.

Stop Metaxalone Tablets, 640 mg three times a day and start Metaxalone Tablets 800 mg three times a day on an empty stomach, OR stop Metaxalone Tablets 640 mg four times a day and start Metaxalone Tablets 800 mg four times a day on an empty stomach. Do not switch from Metaxalone Tablets, 640 mg to Metaxalone Tablets, 800 mg when the patient is taking food during administration. Recommended dosage of metaxalone in adults and pediatric patients 13 years of age and older is 800 mg orally three to four times a day.

( 2 ) Metaxalone Tablets 800 mg are not substitutable on a mg to mg basis with Metaxalone Tablets, 640 mg. When it is appropriate to switch, see the Full Prescribing Information on switching instructions. ( 2 )

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 800 mg pink, capsule shaped, scored tablets, debossed “LCI" on one side and "14" bisect "35" on the other side. The 400 mg strength of metaxalone is not currently marketed by Lannett Company, Inc. Tablets: 800 mg pink, capsule shaped, scored tablet, debossed with “LCI” on one side and “14” bisect “35” on the other side. ( 3 )

⛔ Contraindications 60 words ▾

4 CONTRAINDICATIONS Metaxalone is contraindicated in patients with: Known hypersensitivity to any component of metaxalone. Known tendency to drug induced, hemolytic, or other anemias. Severe renal or hepatic impairment. Known hypersensitivity to any components of this product. ( 4 ) Known tendency to drug induced, hemolytic, or other anemias. ( 4 ) Severe renal or hepatic impairment. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of metaxalone (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone as the only serotonergic drug taken at a dosage higher than the recommended dosage. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dosage increases. Discontinue metaxalone if serotonin syndrome is suspected or it occurs.

( 5.1 , 7.1 ) Central Nervous System (CNS) Depression : Metaxalone may impair mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with other CNS depressants including alcohol. Follow patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases.

( 5.2 , 7.2 )

5.1Serotonin Syndrome Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of metaxalone (within the recommended dosage range) and other serotonergic drugs [see Drug Interactions ( 7 )] and with the use of metaxalone as the only serotonergic drug taken at a dosage higher than the recommended dosage [see Overdosage ( 10 )] . 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 after initiation of a serotonergic drug, but may occur later than that. If concomitant use of metaxalone and another serotoneric drug is warranted, reassess the patient, particularly during treatment initiation and dosage increases. Discontinue metaxalone if serotonin syndrome is suspected or it occurs.

5.2Central Nervous System Depression Because of its central nervous system (CNS) depressant effects, 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 other CNS depressants including alcohol. Geriatric patients may be especially susceptible to CNS depression associated with metaxalone use. When used concomitantly, the sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive [see Drug Interactions ( 7 )] .

Follow metaxalone-treated patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use of metaxalone and another CNS depressant is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases.

🤒 Adverse Reactions 184 words ▾

6 ADVERSE REACTIONS The following adverse reactions associated with the use of metaxalone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequent reactions to metaxalone were: CNS: drowsiness, dizziness, headache, and nervousness or "irritability".

Digestive: nausea, vomiting, gastrointestinal upset. Other adverse reactions were: CNS: cases of serotonin syndrome have been reported during concomitant use of metaxalone (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone as the only serotonergic drug at a dosage higher than the recommended dosage [see Warnings and Precautions ( 5.1 ) , Drug Interactions ( 7.1 ) and Overdosage ( 10 )] . Hematologic: leukopenia; hemolytic anemia; Hepatobiliary: jaundice; Immune System: anaphylaxis, hypersensitivity reaction, rash with or without pruritus.

Most common adverse reactions (incidence >5%) are nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Serotonergic Drugs If concomitant use of metaxalone and another serotoneric drug is warranted, carefully observe the patient, particularly during treatment initiation and dosage modification. Discontinue metaxalone if serotonin syndrome is suspected or if it occurs. Serotonin syndrome has resulted from concomitant use of metaxalone (within the recommended dosage range) with other serotonergic drugs [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6 )] .

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).

7.2CNS Depressants If concomitant use of metaxalone and another CNS depressant is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases. Due to the additive pharmacologic effect, concomitant use of metaxalone with other CNS depressants may increase the risk of sedation and respiratory depression [see Warnings and Precautions ( 5.2 )] .

7.3Interaction of Metaxalone with Benedict’s Tests False-positive Benedict's tests, due to an unknown reducing substance, have been noted in metaxalone-treated patients. A glucose-specific test will differentiate findings.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric Use : Metaxalone-treated geriatric patients may be especially susceptible to CNS depression. ( 8.5 )

8.1Pregnancy Risk Summary There are no available data on metaxalone use in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes despite decades of metaxalone use. Reproduction studies in rats have not revealed effects on the fetus due to metaxalone. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary There are no data available to evaluate the presence of metaxalone or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metaxalone and any potential adverse effects on the breastfed infant from metaxalone or from the underlying maternal condition.

8.4Pediatric Use Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in pediatric patients 13 years of age and older. The safety and effectiveness of metaxalone in pediatric patients 12 years of age or younger have not been established.

8.5Geriatric Use Clinical studies of metaxalone did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Geriatric patients may be especially susceptible to CNS depression associated with metaxalone use [see Warnings and Precautions ( 5.2 )] . The recommended metaxalone dosage in patients 65 years of age and older is the same as in younger adult patients.

Metaxalone peak plasma concentrations (C max ) and area under the curve (AUC) were higher in patients 65 years of age and older in the fasted state; however, a clinically significant difference was not observed when metaxalone was administered in the fed state [see Clinical Pharmacology ( 12.3 )] .

8.6Hepatic Impairment Metaxalone is contraindicated in patients with severe hepatic impairment. Metaxalone should be used with caution and additional follow-up should be considered in patients with mild to moderate hepatic impairment. The effect of hepatic impairment on metaxalone pharmacokinetics is unknown; however, metaxalone undergoes expensive hepatic metabolism [see Clinical Pharmacology ( 12.3 )] .

8.7Renal Impairment Metaxalone is contraindicated in patients with severe renal impairment. Metaxalone should be used with caution and additional follow-up should be considered in patients with mild to moderate renal impairment. The effect of renal impairment on metaxalone pharmacokinetics is unknown; however, metaxalone undergoes renal excretion as unidentified metabolites [see Clinical Pharmacology ( 12.3 )] .

🤰 Pregnancy 109 words ▾

🧓 Geriatric Use 121 words ▾

🆘 Overdosage 149 words ▾

10 OVERDOSAGE Clinical Presentation of Metaxalone Overdose Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with other CNS depressants (including alcohol). CNS manifestations may include CNS depression, agitation, hallucinations, delusions, seizures, respiratory depression, and coma. Cardiovascular effects may include tachycardia and hypertension; hypotension has also been reported.

Serotonin syndrome, leading to muscle rigidity, tremor, and hyperthermia, has been reported [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 , 7.2 )] . Treatment of Metaxalone Overdose The standard of treatment is supportive care. Monitor for CNS and respiratory depression and manage airway with oxygen as needed.

Gastrointestinal decontamination procedures (including emesis) should generally be avoided because aspiration may result from CNS depression and seizures. Extracorporeal elimination such as hemodialysis or plasmapheresis have no proven clinical benefit. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Metaxalone’s mechanism of action has not been fully characterized, but may be related to its sedative properties. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate, or the nerve fiber.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of metaxalone not been fully characterized.

12.3Pharmacokinetics Metaxalone pharmacokinetics were evaluated in two groups of healthy volunteers that received a single oral dose of 800 mg of metaxalone or 400 mg of metaxalone (0.5 times the approved recommended dose) [the 400 mg strength of metaxalone is not currently marketed by Lannett Company, Inc.]. Metaxalone pharmacokinetic parameters are presented below as mean (% CV) unless otherwise specified. Observed metaxalone peak plasma concentrations (C max ) and area under the curve (AUC) are shown in Table 1.

Doubling the dose of metaxalone from 400 mg (0.5 times the approved recommended dose) to 800 mg resulted in a proportional increase in metaxalone C max and AUC. Table 1: Metaxalone Exposure after a Single-Dose of Metaxalone Under Fasting Conditions Dose C max 2 AUC ∞ 2 400 mg 1 983 (53) ng/mL 7,479 (51) ng•h/mL 800 mg 1,816 (43) ng/mL 15,044 (46) ng•h/mL 1 0.5 times the approved recommended dose 2 Mean (% CV) Absorption The absolute bioavailability of metaxalone is not known. Peak plasma metaxalone concentrations occurred at a mean T max of 3.3 hours (1.5 – 5 hours) of metaxalone under fasted conditions.

The single-dose pharmacokinetic parameters of metaxalone in two groups of healthy volunteers who received 400 mg or 800 mg of metaxalone are shown in Table 1. Effect of Food: Peak plasma metaxalone concentrations were noted at a mean T max of 4.3 hours (1.5 – 12 hours) under fed conditions. The mean T max under fasting and fed conditions was 3.3 and 4.3 hours, respectively.

Metaxalone exposure was increased and the half-life (t 1/2 ) was decreased following metaxalone administration with a high fat meal as shown in Table 2. 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. Table 2: Relative Changes in Metaxalone Exposure, T max , and t 1/2 Following Metaxalone Administration with a High Fat Meal Compared to Fasting Dose (mg) C max (ng/mL) AUC 0-t (ng•h/mL) AUC 0-INF (ng∙h/mL) T max (hrs) t 1/2 (hrs) 400 mg* ↑ 78% ↑ 24% ↑ 15% ↑ 30% ↓ 73% 800 mg ↑ 94% ↑ 46% ↑ 42% ↑ 63% ↓ 48% * 0.5 times the approved recommended dose.

Distribution Metaxalone apparent volume of distribution is approximately 800 Liters; however, plasma protein binding is unknown. Elimination Metaxalone mean ± SD terminal t 1/2 is 9 ± 4.8 hours and apparent clearance is approximately 67 ± 34 L/h under fasted conditions. Metabolism: Metaxalone is primarily metabolized by CYP1A2, CYP2D6, CYP2E1, and CYP3A4 and, to a lesser extent, CYP2C8, CYP2C9, and CYP2C19.

Excretion: Metaxalone is metabolized by the liver and excreted in the urine as unidentified metabolites. Specific Populations The effect of renal impairment and hepatic impairment on metaxalone pharmacokinetics is unknown [see Use in Specific Populations ( 8.6 , 8.7 )] . Geriatric Patients: The effects of age on the pharmacokinetics of metaxalone were determined following administration of 800 mg of metaxalone under fasted and fed conditions.

Age had a significantly greater effect on metaxalone pharmacokinetics under fasted conditions than under fed conditions. Bioavailability under fasted conditions increased with age. Metaxalone bioavailability under fasted and fed conditions in the three groups of healthy volunteers of varying age is shown in Table 3.

Table 3: Metaxalone Pharmacokinetic Parameters under Fasted and Fed Conditions in Three Age Groups Following Oral Administration of 800 mg of Metaxalone Mean Age in Years (±…

🧬 Mechanism of Action 41 words ▾

📦 How Supplied / Storage and Handling 74 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 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. Available in bottles of 100 (NDC 0527-1435-01) and in bottles of 500 (NDC 0527-1435-05). The 400 mg strength of Metaxalone Tablets, USP is not currently marketed by Lannett Company, Inc. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

📋 Description 104 words ▾

11 DESCRIPTION Metaxalone Tablets, USP contain 800 mg of 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 is a muscle relaxant for oral administration. 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. image

💬 Information for Patients 126 words ▾

17 PATIENT COUNSELING INFORMATION Serotonin Syndrome Inform patients that metaxalone could cause a rare but potentially life-threatening condition called serotonin syndrome. 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 drugs [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )] .

Central Nervous System Depression Advise patients that 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 and other CNS depressants [see Drug Interactions ( 7.2 )] . Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB71144F Rev.

06/2024

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

sedative: A substance with a calming effect that can also cause drowsiness.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 00527-1407-01 · Lannett 00527-1475-01 · Lannett →

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.

Metaxalone 800 mg Tablet, 500-count

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