Metaxalone 800 mg Tablet, 30-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
Where does this data come from?
🩺 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 H0G9379FGK
Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
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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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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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 | $51.92 / 30 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 mg 61919-0832-90 | DIRECT | 90 tablets | — | AB | FDA listed | — |
| Metaxalone 800 mgthis 63187-0490-30 | Proficient | 30 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 |
|---|---|---|---|
| 63187-0490-10 | 10 TABLET in 1 BOTTLE (63187-490-10) | 2015-02-02 | Active |
| 63187-0490-30 You're viewing this | 30 TABLET in 1 BOTTLE (63187-490-30) | 2015-02-02 | Active |
| 63187-0490-60 | 60 TABLET in 1 BOTTLE (63187-490-60) | 2015-02-02 | Active |
| 63187-0490-90 | 90 TABLET in 1 BOTTLE (63187-490-90) | 2015-02-02 | Active |
You're viewing one of 4 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 63187-0490-30?
What is the difference between NDC 63187-0490-30 and NDC 63187-0490-10?
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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 ▾
WARNINGS Metaxalone may enhance the effects of alcohol and other CNS depressants.
🤒 Adverse Reactions ▾
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 ▾
Drug Interactions The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, 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 ▾
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 ▾
Pediatric Use Safety and effectiveness in children 12 years of age and below have not been established.
🆘 Overdosage ▾
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 ▾
CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. Pharmacokinetics The pharmacokinetics of metaxalone have been evaluated in healthy adult volunteers after single dose administration of metaxalone under fasted and fed conditions at doses ranging from 400 mg to 800 mg.
Absorption Peak plasma concentrations of metaxalone occur approximately 3 hours after a 400 mg oral dose under fasted conditions. Thereafter, metaxalone concentrations decline log-linearly with a terminal half-life of 9.0 ± 4.8 hours. Doubling the dose of metaxalone from 400 mg to 800 mg results in a roughly proportional increase in metaxalone exposure as indicated by peak plasma concentrations (C max ) and area under the curve (AUC).
Dose proportionality at doses above 800 mg has not been studied. The absolute bioavailability of metaxalone is not known. The single-dose pharmacokinetic parameters of metaxalone in two groups of healthy volunteers are shown in Table 1.
Table 1: Mean (%CV) Metaxalone Pharmacokinetic Parameters Dose (mg) C max (ng/mL) T max (h) AUC ∞ (ng•h/mL) t ½ (h) CL/F (L/h) 400 1 983 (53) 3.3 (35) 7479 (51) 9.0 (53) 68 (50) 800 2 1816 (43) 3.0 (39) 15044 (46) 8.0 (58) 66 (51) 1 Subjects received 1x400 mg tablet under fasted conditions (N=42) 2 Subjects received 2x400 mg tablets under fasted conditions (N=59) Food Effects A randomized, two-way, crossover study was conducted in 42 healthy volunteers (31 males, 11 females) administered one 400 mg metaxalone tablet under fasted conditions and following a standard high-fat breakfast.
Subjects ranged in age from 18 to 48 years (mean age = 23.5 ± 5.7 years). Compared to fasted conditions, the presence of a high fat meal at the time of drug administration increased C max by 177.5% and increased AUC (AUC 0-t , AUC ∞ ) by 123.5% and 115.4%, respectively. Time-to-peak concentration (T max ) was also delayed (4.3 h versus 3.3 h) and terminal half-life was decreased (2.4 h versus 9.0 h) under fed conditions compared to fasted.
In a second food effect study of similar design, two 400 mg metaxalone tablets (800 mg) were administered to healthy volunteers (N=59, 37 males, 22 females), ranging in age from 18 to 50 years (mean age = 25.6± 8.7 years). Compared to fasted conditions, the presence of a high fat meal at the time of drug administration increased C max by 193.6% and increased AUC (AUC 0-t , AUC ∞ ) by 146.4% and 142.2%, respectively. Time-to-peak concentration (T max ) was also delayed (4.9 h versus 3.0 h) and terminal half-life was decreased (4.2 h versus 8.0 h) under fed conditions compared to fasted conditions.
Similar food effect results were observed in the above study when one metaxalone 800 mg tablet was administered in place of two metaxalone 400 mg tablets. The increase in metaxalone exposure coinciding with a reduction in half-life may be attributed to more complete absorption of metaxalone in the presence of a high fat meal (Figure 1). figure 1 Distribution, Metabolism, and Excretion Although plasma protein binding and absolute bioavailability of metaxalone are not known, the apparent volume of distribution (V/F ~ 800 L) and lipophilicity (log P = 2.42) of metaxalone suggest that the drug is extensively distributed in the tissues.
Metaxalone is metabolized by the liver and excreted in the urine as unidentified metabolites. Hepatic Cytochrome P450 enzymes play a role in the metabolism of metaxalone. Specifically, CYP1A2, CYP2D6, CYP2E1, and CYP3A4 and, to a lesser extent, CYP2C8, CYP2C9, and CYP2C19 appear to metabolize metaxalone.
Metaxalone does not significantly inhibit major CYP enzymes such as CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4. Metaxalone does not significantly induce major CYP enzymes such as CYP1A2, CY…
🧬 Mechanism of Action ▾
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 ▾
HOW SUPPLIED Metaxalone is available as an 800 mg , light pink to pink, capsule shaped, scored uncoated tablet with debossing ‘AN’ on the left side of the scoring and ‘553’ on the right side of the scoring. Other side of the tablet is plain. They are available as follows: Bottles of 10: NDC 63187-490-10 Bottles of 30: NDC 63187-490-30 Bottles of 60: NDC 63187-490-60 Bottles of 90: NDC 63187-490-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Rx Only Manufactured By: Amneal Pharmaceuticals Co. (I) Pvt. Ltd.
Ahmedabad, INDIA 382220 Distributed By: Amneal Pharmaceuticals Glasgow, KY 42141 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 Rev. 05-2012
📋 Description ▾
DESCRIPTION Metaxalone is available as an 800 mg, light pink to pink, capsule shaped, scored uncoated tablet. Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C 12 H 15 NO 3 , which corresponds to a molecular weight of 221.25.
The structural formula is: Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: calcium carbonate, FD&C Red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, silicone dioxide, sodium starch glycolate and sodium stearyl fumarate. chemical structure
💬 Information for Patients ▾
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.