METAXALONE 800 mg Tablet, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Muscle Relaxant class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metaxalone — tap one for details:
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💊 What it looks like
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🧪 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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?
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
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💲 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 | $173.07 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 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 mgthis 61919-0832-71 | DIRECT | 100 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 | — |
Where does this data come from?
⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61919-0832-90 | 90 TABLET in 1 BOTTLE (61919-832-90) | 2019-05-03 | Active |
| 61919-0832-30 | 30 TABLET in 1 BOTTLE (61919-832-30) | 2019-06-26 | Active |
| 61919-0832-60 | 60 TABLET in 1 BOTTLE (61919-832-60) | 2019-08-29 | Active |
| 61919-0832-71 You're viewing this | 100 TABLET in 1 BOTTLE (61919-832-71) | 2020-01-06 | Active |
| 61919-0832-72 | 120 TABLET in 1 BOTTLE (61919-832-72) | 2020-01-06 | Active |
You're viewing one of 5 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 61919-0832-71?
What is the difference between NDC 61919-0832-71 and NDC 61919-0832-30?
What NDC number is used to bill for this package of METAXALONE 800 mg Tablet?
🧭 About this NDC listing & data coverage
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. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Metaxalone tablets are 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 ▾
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
⛔ 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 ▾
Metaxalone tablets may enhance the effects of alcohol and other CNS depressants.
🤒 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.
🆘 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 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 ▾
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 tablets 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 tablets from 400 mg to 800 mg results in a roughly proportional increase in metaxalone exposure as indicated by peak plasma concentrations (Cmax) 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 * Subjects received 1x400 mg tablet under fasted conditions (N=42) † Subjects received 2x400 mg tablets under fasted conditions (N=59) Dose (mg) Cmax (ng/mL) Tmax (h) AUC∞ (ng●h/mL) T1/2 (h) CL/F (L/h) 400* 983 (53) 3.3 (35) 7479 (51) 9.0 (53) 68 (50) 800† 1816 (43) 3.0 (39) 15044 (46) 8.0 (58) 66 (51) 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 Cmax by 177.5% and increased AUC (AUC0-t, AUC∞) by 123.5% and 115.4%, respectively. Time-to-peak concentration (Tmax) 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 Cmax by 193.6% and increased AUC (AUC0-t, AUC∞) by 146.4% and 142.2%, respectively. Time-to-peak concentration (Tmax) 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 [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, CPY2E1, and CYP…
📦 How Supplied / Storage and Handling ▾
Metaxalone Tablets, USP, for oral administration, are available as 800 mg Rose-colored, capsule-shaped tablets, debossed “E 448” on one side and scored on the other side Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by Sandoz Inc., Princeton, NJ 08540 Rev. May 2016 46188486 MF0448REV05/16
📋 Description ▾
Metaxalone tablets, USP are available as an 800 mg tablet. Chemically, metaxalone is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25.
The structural formula is: [Chemical Structure] 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: corn starch, alginic acid, acacia, sodium starch glycolate, magnesium stearate and FD&C red No. 40 aluminum lake.