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Methocarb 500-EZS Methocarbamol Kit — NDC 59088-0724-00 package photo

Methocarb 500-EZS Methocarbamol Kit

by PureTek Corporation · 1 KIT in 1 KIT (59088-724-00) * 100 TABLET, FILM COATED in 1 BOTTLE (69543-134-10)
NDC 59088-0724-00
🏷️ FDA NDC (as labeled) 59088-724-00 billing pads the product segment with a zero
Rx only 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

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

⚠️
Other active recalls for Methocarbamol (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 21, 2025 — Lack of Assurance of Sterility: Media fill with bacterial contamination (Somerset Therapeutics Private Limited) · FDA recall D-0354-2025
Class I · Feb 15, 2024 — Presence of Particulate Matter (Eugia US LLC) · FDA recall D-0440-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 59088-724-00
Product NDC 59088-724
11-digit billing NDC 59088072400
RxCUI 197943
UPC 0731477272217
SPL Set ID 383ce408-1085-43e7-944e-957ff2a9d553
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-10-23
Dosage form KIT
Why two NDCs? The FDA registers this code as 59088-724-00 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59088-0724-00. 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
Drug family (ATC) Carbamic acid esters
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

LabelerPureTek Corporation
Labeler code59088
First marketedOct 2018
Product typeHuman Prescription Drug
Portfolio176 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Methocarbamol 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. Methocarbamol is in a class of medications called 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
  • Methocarbamol is a muscle relaxant that works through your central nervous system — your brain and spinal cord — rather than directly on the muscles themselves. It's thought to red...
  • What exactly does methocarbamol do? Will it make my muscles stop hurting?
  • You really should not. Methocarbamol already causes drowsiness and slows your central nervous system down. Adding alcohol on top of that significantly increases those effects — we'...
  • Be careful, especially when you first start taking it. Methocarbamol can impair your alertness, coordination, and reaction time. Don't drive or operate heavy machinery until you kn...
📖 Read our full Methocarbamol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color orange
ShapeRound
ImprintAP212
Size13 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methocarbamol 500 mg 00904-7057-61 Major 100 tablets $0.040 AA Availability likely —
Methocarbamol 500 mg 31722-0533-01 Camber 1200 tablets $0.040 AA Availability likely —
Methocarbamol 500 mg 43547-0405-10 Solco 100 tablets $0.040 AA Availability likely —
Methocarbamol 500 mg 50268-0520-15 AvPAK 50 tablets $0.040 AA Availability likely —
Methocarbamol 500 mg 59651-0340-01 Aurobindo 100 tablets $0.040 AA Availability likely —
Methocarbamol 500 mg 60687-0559-01 American 100 tablets $0.040 AA Availability likely —
Methocarbamol Tablets, USP, 500 mg 63561-0173-01 Granulation 100 tablets $0.040 AA Availability likely —
Methocarbamol 500 mg 70010-0754-01 Granules 100 tablets $0.040 AA Availability likely —
Methocarbamol 500 mg 76385-0123-01 UNICHEM 100 tablets $0.040 AA Availability likely —
Methocarbamol 500 mg 00615-8506-05 NCS 15 tablets — AA FDA listed —
Methocarbamol Tablets, USP, 500 mg 10135-0722-01 Marlex 100 tablets — AA FDA listed —
Methocarbamol 500 mg 15014-0910-10 GENTEX 100 tablets — AA FDA listed —
Methocarbamol 500 mg 35561-0212-12 Bostal 100 tablets — AB FDA listed —
Methocarbamol 500 mg 43063-0903-18 PD-Rx 18 tablets — AA FDA listed —
Methocarbamol 500 mg 45865-0242-30 Medsource 30 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-0182-00 A-S 40 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-0183-00 A-S 10 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-0184-00 A-S 40 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-3557-01 A-S 20 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-3570-00 A-S 10 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-3578-00 A-S 40 tablets — AA Discontinued —
Methocarbamol 500 mg 50090-3756-00 A-S 40 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-4793-00 A-S 40 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-5846-00 A-S 10 tablets — AA FDA listed —
Methocarbamol 500 mg 50090-5847-00 A-S 40 tablets — AA Discontinued —
Methocarbamol 500 mg 50090-5907-00 A-S 40 tablets — AA FDA listed —
Methocarbamol 500 mg 51407-0467-01 Golden 100 tablets — AA FDA listed —
Methocarbamol 500 mg 51655-0195-51 Northwind 40 tablets — AA FDA listed —
Methocarbamol 500 mg 51655-0574-52 Northwind 30 tablets — AA FDA listed —
Methocarbamol 500 mg 55154-2129-00 Cardinal 10 tablets — AA FDA listed —
Methocarbamol 500 mg 55154-2334-00 Cardinal 10 tablets — AA FDA listed —
Methocarbamol 500 mg 55700-0890-60 Quality 60 tablets — AA Discontinued —
Methocarb 500-EZSthis 59088-0724-00 PureTek 100 tablets — — FDA listed —
Methocarbamol 500 mg 60760-0592-90 St. 90 tablets — AA FDA listed —
Methocarbamol 500 mg 61919-0368-07 DIRECT 7 tablets — AA FDA listed —
Methocarbamol 500 mg 62207-0754-41 Granules 24 tablets — AA FDA listed —
Methocarbamol 500 mg 63187-0087-00 Proficient 100 tablets — AA FDA listed —
Methocarbamol 500 mg 63629-1123-01 Bryant 500 tablets — — FDA listed —
Methocarbamol 500 mg 63629-1622-00 Bryant 15 tablets — AA FDA listed —
Methocarbamol 500 mg 63629-2417-01 Bryant 500 tablets — AA Discontinued —
Methocarbamol 500 mg 63629-2418-01 Bryant 100 tablets — AA FDA listed —
Methocarbamol 500 mg 63629-4882-01 Bryant 60 tablets — AA FDA listed —
Methocarbamol 500 mg 63629-9288-01 Bryant 100 tablets — AA FDA listed —
Methocarbamol 500 mg 67046-0538-03 Coupler 30 tablets — AA FDA listed —
Methocarbamol 500 mg 67296-1435-01 Redpharm 15 tablets — AA FDA listed —
Methocarbamol 500 mg 67296-2193-01 Redpharm 15 tablets — AA FDA listed —
Methocarbamol 500 mg 67296-2197-01 Redpharm 15 tablets — AA FDA listed —
Methocarbamol 500 mg 68071-3636-06 NuCare 6 tablets — AA FDA listed —
Methocarbamol 500 mg 68071-4520-02 NuCare 20 tablets — AA FDA listed —
Methocarbamol 500 mg 68788-7973-03 Preferred 30 tablets — AA FDA listed —
Methocarbamol 500 mg 68788-8213-03 Preferred 30 tablets — AA FDA listed —
Methocarbamol 500 mg 68788-8822-01 Preferred 100 tablets — AA FDA listed —
Methocarbamol 500 mg 68788-8867-03 Preferred 30 tablets — AA FDA listed —
Methocarbamol 500 mg 68788-8880-03 Preferred 30 tablets — AA FDA listed —
Methocarbamol 500 mg 69306-0500-01 Doc 100 tablets — AA FDA listed —
Methocarbamol 500 mg 69306-0510-01 Doc 100 tablets — AA FDA listed —
Methocarbamol 500 mg 69584-0611-09 Oxford 90 tablets — AA FDA listed —
Methocarbamol 500 mg 70518-1723-03 REMEDYREPACK 30 tablets — AA FDA listed —
Methocarbamol 500 mg 70518-4603-00 REMEDYREPACK 40 tablets — AA FDA listed —
Methocarbamol 500 mg 70868-0910-10 Key 100 tablets — AA FDA listed —
Methocarbamol 500 mg 71205-0103-20 Proficient 20 tablets — AA FDA listed —
Methocarbamol 500 mg 71205-0167-30 Proficient 30 tablets — AA FDA listed —
Methocarbamol 500 mg 71205-0375-20 Proficient 20 tablets — — FDA listed —
Methocarbamol 500 mg 71335-0970-00 Bryant 15 tablets — AA FDA listed —
Methocarbamol 500 mg 71335-1795-00 Bryant 15 tablets — — FDA listed —
Methocarbamol 500 mg 71335-2383-00 Bryant 15 tablets — AA FDA listed —
Methocarbamol 500 mg 71335-2794-00 Bryant 15 tablets — AA FDA listed —
Methocarbamol 500 mg 71335-3105-01 Bryant 60 tablets — AA FDA listed —
Methocarbamol 500 mg 71610-0599-30 Aphena 30 tablets — — FDA listed —
Methocarbamol 500 mg 71610-0832-30 Aphena 30 tablets — AA FDA listed —
Methocarbamol 500 mg 72162-1363-01 Bryant 100 tablets — — FDA listed —
Methocarbamol 500 mg 72162-1929-01 Bryant 100 tablets — AA FDA listed —
Methocarbamol Tablets, USP, 500 mg 72162-2487-01 Bryant 100 tablets — AA FDA listed —
Methocarbamol 500 mg 72189-0284-30 DirectRx 30 tablets — AA FDA listed —
Methocarbamol 500 mg 72189-0665-30 Direct_rx 30 tablets — AA FDA listed —
Methocarbamol 500 mg 72789-0012-18 PD-Rx 18 tablets — AA FDA listed —
Methocarbamol 500 mg 72789-0021-01 PD-Rx 100 tablets — AA FDA listed —
Methocarbamol 500 mg 72789-0110-40 PD-Rx 40 tablets — AA FDA listed —
Methocarbamol 500 mg 72789-0397-01 PD-Rx 100 tablets — AA FDA listed —
Methocarbamol 500 mg 72789-0428-18 PD-Rx 18 tablets — AA FDA listed —
Methocarbamol Tablets, USP, 500 mg 72789-0481-01 PD-Rx 100 tablets — AA FDA listed —
Methocarbamol Tablets, USP, 500 mg 72789-0499-18 PD-Rx 18 tablets — AA FDA listed —
Methocarbamol 500 mg 72865-0233-01 XLCare 100 tablets — AA FDA listed —
Methocarbamol 500 mg 76420-0626-01 Asclemed 100 tablets — AA FDA listed —
Methocarbamol 500 mg 76420-0667-01 Asclemed 100 tablets — AA FDA listed —
Methocarbamol 500 mg 76420-0893-01 Asclemed 100 tablets — AA FDA listed —
Methocarbamol 500 mg 80425-0138-01 Advanced 60 tablets — AA FDA listed —
Methocarbamol 500 mg 80425-0275-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 500 mg 80425-0283-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 500 mg 80425-0577-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 500 mg 80425-0578-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 500 mg 80425-0579-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 500 mg 82804-0121-30 Proficient 30 tablets — AA FDA listed —
Methocarbamol 500 mg 82804-0273-30 Proficient 30 tablets — AA FDA listed —
Methocarbamol 500 mg 82804-0954-00 Proficient 100 tablets — AA FDA listed —
Methocarbamol 500 mg 85509-1910-01 PHOENIX 100 tablets — AA FDA listed —
Methocarbamol 500 mg 85509-2910-01 PHOENIX 100 tablets — AA FDA listed —
Methocarbamol 500 mg 87063-0040-01 Asclemed 100 tablets — AA FDA listed —
Methocarbamol 500 mg 87063-0135-01 ASCLEMED 100 tablets — AA FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2018
On the market since
Oct 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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

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

Medicare Part D (outpatient prescription) spending for Methocarbamol (matched by generic name) — the program that covers self-administered drugs. 17 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 Methocarbamol. CMS lists 2 products for this generic; we show the highest-spend one. 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
$13.41M
Claims incl. refills
1.1M
Beneficiaries
734.7K
Spend / beneficiary
$18.26
Spend / claim
$12.07
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 Methocarb 500-EZS (this brand).

Top reported reactions

Fatigue1,223
Pain1,210
Nausea1,157
Headache935
Diarrhoea839
Fall796
Dyspnoea759

Age at onset

Neonate4
Infant2
Child20
Adolescent14
Adult2,239
Elderly1,169

Reporter sex

16,628 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Death1,393
Disabling411
Life-threatening400
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,485 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59088-0724-00 You're viewing this 1 KIT in 1 KIT (59088-724-00) * 100 TABLET, FILM COATED in 1 BOTTLE (69543-134-10) 2018-10-23 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application Kit / multi-component package

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 59088-724-00, 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: 59088-0724-00, written without dashes as 59088072400. 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 59088-0724-00, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0724) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 56 words ▾

INDICATIONS AND USAGE Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

⏱️ Dosage and Administration 75 words ▾

DOSAGE AND ADMINISTRATION Methocarbamol, 500 mg — Adults: Initial dosage: 3 tablets q.i.d. Maintenance dosage: 2 tablets q.i.d. Methocarbamol, 750 mg — Adults: Initial dosage: 2 tablets q.i.d. Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d. Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS Methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

⚠️ Warnings 152 words ▾

WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol tablets should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol.

Therefore, methocarbamol tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS, Pregnancy ). Use In Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.

🤒 Adverse Reactions 82 words ▾

ADVERSE REACTIONS Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system: Leukopenia Immune system: Hypersensitivity reactions Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

🔄 Drug Interactions 36 words ▾

Drug Interactions See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol. Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

🔄 Drug / Laboratory Test Interactions 33 words ▾

Drug/Laboratory Test Interactions Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.

🤰 Pregnancy 116 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol should be given to a pregnant woman only if clearly needed.

Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol.Therefore, methocarbamol should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS ).

🧒 Pediatric Use 19 words ▾

Pediatric Use Safety and effectiveness of methocarbamol in pediatric patients below the age of 16 have not been established.

🆘 Overdosage 101 words ▾

OVERDOSAGE Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma. In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

Treatment Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. Pharmacokinetics In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and

0.80L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%. Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely.

Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine. Special populations Elderly The mean (± SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), healthy population (1.5 (±0.4) hours versus 1.1 (± 0.27) hours, respectively).

The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively). Renally impaired The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (± SD) elimination half-life in these two groups was similar: 1.2 (± 0.6) versus 1.1 (± 0.3) hours, respectively. Hepatically impaired In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects.

The mean (± SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (±1.62) hours and 1.11 (± 0.27) hours, respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.

📦 How Supplied / Storage and Handling 76 words ▾

HOW SUPPLIED Methocarbamol Tablets USP, 500 mg — Orange, film coated, round convex tablets with one side debossed 'AP212', the other side bisected. Available in bottles of 100 and 500. Methocarbamol Tablets USP, 750 mg — Yellow, film coated, modified capsule shaped tablets; one side debossed 'AP211' and other side blank.

Available in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

📦 Storage and Handling 18 words ▾

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

📋 Description 183 words ▾

DESCRIPTION Methocarbamol Tablets USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C 11 H 15 NO 5 . Its molecular weight is 241.24.

The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablet, 500 mg is available as an orange, film coated, round convex tablet containing 500 mg of methocarbamol, USP for oral administration.

The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide.

Chemical Structure

💬 Information for Patients 46 words ▾

Information for Patients Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery. Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.