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Methocarbamol Tablets, USP, 500 mg 500 mg Tablet, Film Coated, 100-count — NDC 72789-0481-01 package photo

Methocarbamol Tablets, USP, 500 mg 500 mg Tablet, Film Coated, 100-count

by PD-Rx Pharmaceuticals, Inc. · 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-481-01)
NDC 72789-0481-01
🏷️ FDA NDC (as labeled) 72789-481-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes7 compare ↓
Also comes in: 30 tablets 72789-0481-30 60 tablets 72789-0481-60 90 tablets 72789-0481-90 180 tablets 72789-0481-93 500 tablets 72789-0481-82 1000 tablets 72789-0481-95
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) 72789-481-01
Product NDC 72789-481
11-digit billing NDC 72789048101
NCPDP billing unit EA — each (per item)
RxCUI 197943
UNII 125OD7737X
UPC 0372789481302
Application # ANDA212623
SPL Set ID 6ca768bf-5095-4148-82d2-a0c2dec16d87
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 2025-06-10
Route ORAL
Dosage form TABLET, FILM COATED
Substance METHOCARBAMOL
GCN Seq No 004654
GCN 17892
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 500 MG TABLET
FDB brand name Methocarbamol
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 72789-481-01 — 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 → 72789-0481-01. 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

LabelerPD-Rx Pharmaceuticals, Inc.
Application holderPOINTVIEW HOLDINGS LLC
FDA applicationANDA212623 (ANDA)
Labeler code72789
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio831 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 500 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 white
ShapeRound
ImprintG173
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 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.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

Price 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.
Try another pack size: 30 tablets 60 tablets 90 tablets 180 tablets 500 tablets 1000 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 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-EZS 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 mgthis 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 —
Methocarbamol 500 mg 85534-0021-00 HAWAII 30 tablets — AA FDA listed —
Methocarbamol 500 mg 87441-0057-01 Unit 30 tablets — AA FDA listed —
Methocarbamol 500 mg 85534-0057-00 HAWAII 30 tablets — AA FDA listed —
Methocarbamol Tablets, USP, 500 mg 72789-0581-40 PD-Rx 40 tablets — AA FDA listed —
Methocarbamol 500 mg 82461-0722-90 Medcore 90 tablets — AA FDA listed —
Methocarbamol 500 mg 67046-1177-03 Coupler 30 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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 (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 Methocarbamol Tablets, USP, 500 mg (this brand).

Top reported reactions

Fatigue1,223
Pain1,210
Nausea1,158
Headache935
Diarrhoea839
Fall796
Dyspnoea759

Age at onset

Neonate4
Infant2
Child20
Adolescent14
Adult2,239
Elderly1,169

Reporter sex

16,629 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization5,037
Death1,393
Disabling411
Life-threatening400
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 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
72789-0481-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-481-01) 2025-06-10 Active
72789-0481-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-481-30) 2025-09-03 Active
72789-0481-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-481-60) 2025-06-10 Active
72789-0481-82 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-481-82) 2025-06-10 Active
72789-0481-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-481-90) 2025-06-10 Active
72789-0481-93 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-481-93) 2025-06-10 Active
72789-0481-95 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-481-95) 2025-06-10 Active

You're viewing one of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72789-0481-01?
NDC 72789-0481-01 is a 100-count package — 100 tablet, film coated in 1 bottle, plastic.
What is the difference between NDC 72789-0481-01 and NDC 72789-0481-30?
Both are Methocarbamol Tablets, USP, 500 mg 500 mg Tablet, Film Coated — the drug itself is identical. NDC 72789-0481-01 is the 100-count package, while NDC 72789-0481-30 is the 30 tablets package.
What NDC number is used to bill for this package of Methocarbamol Tablets, USP, 500 mg 500 mg Tablet, Film Coated?
Bill NDC 72789-0481-01 — the 11-digit billing format is 72789048101. 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) ✓ 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 72789-481-01, 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: 72789-0481-01, written without dashes as 72789048101. 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 72789-0481-01, the first segment (72789) is the labeler code FDA assigned to PD-Rx Pharmaceuticals, Inc.; the middle segment (0481) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 PD-Rx Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 30 tablets (72789-0481-30), 60 tablets (72789-0481-60), 90 tablets (72789-0481-90). 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?
PD-Rx Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ 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 58 words ▾

INDICATIONS AND USAGE Methocarbamol Tablets, USP are 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 89 words ▾

DOSAGE AND ADMINISTRATION Methocarbamol Tablets, USP, 500 mg – Adults: Initial dosage: 3 tablets four times daily Maintenance dosage: 2 tablets four times daily Methocarbamol Tablets, USP, 750 mg – Adults: Initial dosage: 2 tablets four times daily Maintenance dosage: 1 tablet every 4 hours or 2 tablets three 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 18 words ▾

CONTRAINDICATIONS Methocarbamol Tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

⚠️ Warnings 156 words ▾

WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol Tablets, USP should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Methocarbamol Tablets, USP 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, USP 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 120 words ▾

Pregnancy Teratogenic Effects 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 Tablets, USP should be given to a pregnant woman only if clearly needed.

Safe use of Methocarbamol Tablets, USP 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, USP 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 21 words ▾

Pediatric Use Safety and effectiveness of Methocarbamol Tablets, USP 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 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 101 words ▾

HOW SUPPLIED Methocarbamol Tablets, USP, 500 mg tablets are white, round, film-coated tablets, debossed "G173" on one side, plain and scored on the other side. They are supplied as follows: NDC 72789-481-30 Bottles of 30 NDC 72789-481-60 Bottles of 60 NDC 72789-481-90 Bottles of 90 NDC 72789-481-01 Bottles of 100 NDC 72789-481-93 Bottles of 180 NDC 72789-481-82 Bottles of 500 NDC 72789-481-95 Bottles of 1000 Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. For 100 count, Dispense contents in a tight container with child-resistant closure.

For 500 count, Dispense contents in a tight container.

📦 Storage and Handling 36 words ▾

Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature]. For 100 count, Dispense contents in a tight container with child-resistant closure. For 500 count, Dispense contents in a tight container.

📋 Description 174 words ▾

DESCRIPTION Methocarbamol Tablets, USP, 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 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 Tablets, USP 500 mg are available as a white, round, scored, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration.

The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Methocarbamol Tablets, USP 750 mg are available as a white, capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80.

Methocarbamol structural formula

💬 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 ↗
← 72789-0480-01 · PD-Rx 72789-0482-14 · PD-Rx →
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.