Home › NDC Lookup › Ingredients › Methocarbamol › 35561-0211-12
Methocarbamol 750 mg Tablet, Coated, 100-count — NDC 35561-0211-12 package photo

Methocarbamol 750 mg Tablet, Coated, 100-count

by Bostal LLC · 100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-211-12)
NDC 35561-0211-12
🏷️ FDA NDC (as labeled) 35561-211-12 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $25.20/unit — full pricing hub ↓
Also comes in: 500 tablets 35561-0211-13
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

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) 35561-211-12
Product NDC 35561-211
11-digit billing NDC 35561021112
NCPDP billing unit EA — each (per item)
RxCUI 197943, 197944, 2611794
UNII 125OD7737X
UPC 0335561212129, 0335561211122, 0335561349122, 0335561349139 +2 more
Application # ANDA200958
SPL Set ID d8f10211-f96e-4cf3-9b49-986eb51b703d
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 2018-10-09
Route ORAL
Dosage form TABLET, COATED
Substance METHOCARBAMOL
GPI-14 75100070000310
GPI class Methocarbamol
GCN Seq No 004655
GCN 17893
HICL code 001938
Ingredient (HICL) Methocarbamol
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 METHOCARBAMOL 750 MG TABLET
FDB brand name Methocarbamol
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 35561-211-12 — 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 → 35561-0211-12. 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

LabelerBostal LLC
Application holderBOSTAL LLC
FDA applicationANDA200958 (ANDA)
Labeler code35561
First marketedOct 2018
Product typeHuman Prescription Drug
Portfolio22 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

Label name METHOCARBAMOL 750 MG TABLET Ingredient Methocarbamol
📖 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 / white
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 · Q2 2026 $25.20 $2,520.00 / 100 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methocarbamol 750 mg 00904-7058-61 Major 100 tablets $0.042 AA Availability likely —
Methocarbamol 750 mg 31722-0534-01 Camber 1200 tablets $0.042 AA Availability likely —
Methocarbamol 750 mg 43547-0226-10 Solco 100 tablets $0.042 AA Availability likely —
Methocarbamol 750 mg 50268-0521-15 AvPAK 50 tablets $0.042 AA Availability likely —
Methocarbamol 750 mg 59651-0341-01 Aurobindo 100 tablets $0.042 AA Availability likely —
Methocarbamol 750 mg 60687-0568-01 American 100 tablets $0.042 AA Availability likely —
Methocarbamol Tablets, USP, 750 mg 63561-0174-01 Granulation 100 tablets $0.042 AA Availability likely —
Methocarbamol 750 mg 70010-0770-01 Granules 100 tablets $0.042 AA Availability likely —
Methocarbamol 750 mg 76385-0124-01 UNICHEM 100 tablets $0.042 AA Availability likely —
Methocarbamol 750 mg 00615-8507-39 NCS 30 tablets — AA FDA listed —
Methocarbamol Tablets, USP, 750 mg 10135-0723-01 Marlex 100 tablets — AA FDA listed —
Methocarbamol 750 mgthis 35561-0211-12 Bostal 100 tablets — AB FDA listed —
Methocarbamol 750 mg 43063-0905-14 PD-Rx 14 tablets — AA FDA listed —
Methocarbamol 750 mg 50090-1781-00 A-S 20 tablets — AA FDA listed —
Methocarbamol 750 mg 50090-1783-00 A-S 90 tablets — AA FDA listed —
Methocarbamol 750 mg 50090-3556-00 A-S 20 tablets — AA FDA listed —
Methocarbamol 750 mg 50090-3587-00 A-S 90 tablets — AA FDA listed —
Methocarbamol 750 mg 50090-5006-00 A-S 90 tablets — AA FDA listed —
Methocarbamol 750 mg 50090-5008-00 A-S 20 tablets — AA FDA listed —
Methocarbamol 750 mg 51407-0468-01 Golden 100 tablets — AA FDA listed —
Methocarbamol 750 mg 51655-0205-20 Northwind 20 tablets — AA FDA listed —
Methocarbamol 750 mg 51655-0575-20 Northwind 20 tablets — AA FDA listed —
Methocarbamol 750 mg 55154-2130-00 Cardinal 10 tablets — AA FDA listed —
Methocarbamol 750 mg 55154-2335-00 Cardinal 10 tablets — AA FDA listed —
Methocarbamol 750 mg 60760-0725-28 St. 28 tablets — AA FDA listed —
Methocarbamol 750 mg 60760-0770-28 St. 28 tablets — AA FDA listed —
Methocarbamol 750 mg 61919-0616-30 DIRECT 30 tablets — AA FDA listed —
Methocarbamol 750 mg 62207-0770-41 Granules 24 tablets — AA FDA listed —
Methocarbamol 750 mg 63187-0019-00 Proficient 100 tablets — AA FDA listed —
Methocarbamol 750 mg 63187-0130-30 Proficient 30 tablets — AA FDA listed —
Methocarbamol 750 mg 63629-2419-01 Bryant 500 tablets — AA FDA listed —
Methocarbamol 750 mg 63629-2420-01 Bryant 100 tablets — AA FDA listed —
Methocarbamol 750 mg 63629-8995-01 Bryant 30 tablets — AA FDA listed —
Methocarbamol 750 mg 66267-0146-12 NuCare 12 tablets — AA FDA listed —
Methocarbamol 750 mg 66267-0803-06 NuCare 6 tablets — AA FDA listed —
Methocarbamol 750 mg 67046-1147-03 Coupler 30 tablets — AA FDA listed —
Methocarbamol 750 mg 67296-2203-01 Redpharm 15 tablets — AA FDA listed —
Methocarbamol 750 mg 68071-3859-02 NuCare 20 tablets — AA FDA listed —
Methocarbamol 750 mg 68071-4505-01 NuCare 21 tablets — AA FDA listed —
Methocarbamol 750 mg 68788-7980-03 Preferred 30 tablets — AA FDA listed —
Methocarbamol 750 mg 68788-8172-03 Preferred 30 tablets — AA FDA listed —
Methocarbamol 750 mg 68788-8876-03 Preferred 30 tablets — AA FDA listed —
Methocarbamol 750 mg 69584-0612-09 Oxford 90 tablets — AA FDA listed —
Methocarbamol 750 mg 70518-1738-04 REMEDYREPACK 30 tablets — AA FDA listed —
Methocarbamol 750 mg 70518-4472-00 REMEDYREPACK 90 tablets — AA FDA listed —
Methocarbamol 750 mg 70518-4501-00 REMEDYREPACK 40 tablets — AA FDA listed —
Methocarbamol 750 mg 70868-0901-90 Key 90 tablets — AA FDA listed —
Methocarbamol 750 mg 71205-0068-20 Proficient 20 tablets — AA FDA listed —
Methocarbamol 750 mg 71205-0285-30 Proficient 30 tablets — AA FDA listed —
Methocarbamol 750 mg 71335-0251-00 Bryant 14 tablets — AA FDA listed —
Methocarbamol 750 mg 71335-0828-00 Bryant 14 tablets — AA FDA listed —
Methocarbamol 750 mg 71335-1727-00 Bryant 14 tablets — AA FDA listed —
Methocarbamol 750 mg 71335-2305-00 Bryant 14 tablets — AA FDA listed —
Methocarbamol 750 mg 71335-2795-00 Bryant 14 tablets — AA FDA listed —
Methocarbamol 750 mg 71610-0134-53 Aphena 60 tablets — AA FDA listed —
Methocarbamol 750 mg 71610-0174-53 Aphena 60 tablets — AA FDA listed —
Methocarbamol 750 mg 71610-0598-53 Aphena 60 tablets — AA FDA listed —
Methocarbamol 750 mg 71610-0833-30 Aphena 30 tablets — AA FDA listed —
Methocarbamol 750 mg 72162-1930-01 Bryant 100 tablets — AA FDA listed —
Methocarbamol Tablets, USP, 750 mg 72162-2488-01 Bryant 100 tablets — AA FDA listed —
Methocarbamol 750 mg 72789-0022-01 PD-Rx 100 tablets — AA FDA listed —
Methocarbamol 750 mg 72789-0041-20 PD-Rx 20 tablets — AA FDA listed —
Methocarbamol 750 mg 72789-0398-01 PD-Rx 100 tablets — AA FDA listed —
Methocarbamol 750 mg 72789-0429-20 PD-Rx 20 tablets — AA FDA listed —
Methocarbamol Tablets, USP, 750 mg 72789-0521-20 PD-Rx 20 tablets — AA FDA listed —
Methocarbamol 750 mg 72865-0234-01 XLCare 100 tablets — AA FDA listed —
Methocarbamol 750 mg 76420-0040-30 Asclemed 30 tablets — AA FDA listed —
Methocarbamol 750 mg 76420-0258-10 Asclemed 100 tablets — AA FDA listed —
Methocarbamol 750 mg 76420-0638-01 Asclemed 100 tablets — AA FDA listed —
Methocarbamol 750 mg 76420-0894-01 Asclemed 100 tablets — AA FDA listed —
Methocarbamol 750 mg 80425-0020-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 750 mg 80425-0021-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 750 mg 80425-0171-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 750 mg 80425-0490-01 Advanced 30 tablets — AA FDA listed —
Methocarbamol 750 mg 82804-0955-00 Proficient 100 tablets — AA FDA listed —
Methocarbamol 750 mg 82982-0038-40 Pharmasource 40 tablets — AA FDA listed —
Methocarbamol 750 mg 85509-1341-03 PHOENIX 30 tablets — AA FDA listed —
Methocarbamol 750 mg 85509-1770-03 PHOENIX 30 tablets — AA FDA listed —
Methocarbamol 750 mg 85766-0060-01 Sportpharm 100 tablets — AA FDA listed —
Methocarbamol 750 mg 87063-0041-01 Asclemed 100 tablets — AA FDA listed —
Methocarbamol 750 mg 87063-0689-12 ASCLEMED 120 tablets — AA FDA listed —
Methocarbamol 750 mg 85534-0022-00 HAWAII 30 tablets — AA FDA listed —
Methocarbamol 750 mg 60760-0875-28 St. 28 tablets — AA FDA listed —
Methocarbamol 750 mg 82461-0723-90 Medcore 90 tablets — AA 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

🏛️
2018
On the market since
Oct 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

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

Medicare Part D (outpatient prescription) spending for Methocarbamol — 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. 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 Methocarbamol — the ingredient across all brands.

Top reported reactions

Pain1,731
Nausea1,679
Fatigue1,651
Headache1,300
Diarrhoea1,183
Fall1,096
Dyspnoea1,054

Age at onset

Neonate5
Infant2
Child21
Adolescent18
Adult2,749
Elderly1,386

Reporter sex

22,596 reports
Male · 29%
Female · 70%
Unknown · 0%

Serious outcomes

Hospitalization6,807
Death1,739
Disabling603
Life-threatening535
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,772 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
35561-0211-12 You're viewing this 100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-211-12) 2018-10-09 Active
35561-0211-13 500 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-211-13) 2018-10-09 Active

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

Pack size FAQ

What quantity is in NDC 35561-0211-12?
NDC 35561-0211-12 is a 100-count package — 100 tablet, coated in 1 bottle, plastic.
What is the difference between NDC 35561-0211-12 and NDC 35561-0211-13?
Both are Methocarbamol 750 mg Tablet, Coated — the drug itself is identical. NDC 35561-0211-12 is the 100-count package, while NDC 35561-0211-13 is the 500 tablets package.
What NDC number is used to bill for this package of Methocarbamol 750 mg Tablet, Coated?
Bill NDC 35561-0211-12 — the 11-digit billing format is 35561021112. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ 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 35561-211-12, 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: 35561-0211-12, written without dashes as 35561021112. 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 35561-0211-12, the first segment (35561) is the labeler code FDA assigned to Bostal LLC; the middle segment (0211) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 Bostal LLC. 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 500 tablets (35561-0211-13). 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?
Bostal LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

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

DOSAGE AND ADMINISTRATION Methocarbamol, 500 mg — Adults: Initial dosage: 3 tablets 4 times daily. Maintenance dosage: 2 tablets 4 times daily Methocarbamol, 750 mg — Adults: Initial dosage: 2 tablets 4 times daily. Maintenance dosage: 1 tablet 4 times daily or 2 tablets 3 times daily Methocarbamol, 1000 mg — Adults: Initial dosage: 1 ½ tablets 4 times daily.

Maintenance dosage: 1 tablets 4 times daily 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 95 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).

🤒 Adverse Reactions 98 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 To report SUSPECTED ADVERSE REACTIONS, contact AustarPharma LLC at 1-844-375-5410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 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 1 words ▾

Pregnancy

🧒 Pediatric Use 19 words ▾

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

🆘 Overdosage 62 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.

🧬 Clinical Pharmacology 45 words ▾

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.

📦 How Supplied / Storage and Handling 140 words ▾

HOW SUPPLIED Methocarbamol Tablets USP, 500 mg — Orange, film coated, round concave tablets with one side debossed 'AP212', the other side bisected. They are supplied as follows: Bottles of 100, NDC 35561-212-12 Bottles of 500, NDC 35561-212-13 Methocarbamol Tablets USP, 750 mg — Yellow, film coated, modified capsule shaped tablets; one side debossed 'AP211' and other side blank. They are supplied as follows: Bottles of 100, NDC 35561-211-1 Bottles of 500, NDC 35561-211-13 Methocarbamol Tablets USP, 1000 mg — Orange, film coated, oblong-shaped tablets; one side debossed 'AP349' and other side biscted.

They are supplied as follows: Bottles of 100, NDC 35561-349-12 Bottles of 500, NDC 35561-349-13 Store at controlled room temperature, between 20° to 25°C (68° to 77°F). Dispense in tight container. LBL136 REV050622 revised: May 2022 Manufactured by: AustarPharma, LLC 18 Mayfield Ave Edison, NJ 08837, USA

📋 Description ~1 min read ▾

DESCRIPTION Methocarbamol Tablets USP, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. 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 concave 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.

Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg. Methocarbamol Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 35484-0924-21 · DelCorean, 35561-0212-12 · Bostal →
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.