HomeNDC LookupIngredientsMethocarbamol › 71335-0970-09
Methocarbamol 500 mg Tablet, Film Coated, 7-count — NDC 71335-0970-09 package photo

Methocarbamol 500 mg Tablet, Film Coated, 7-count

by Bryant Ranch Prepack · 7 TABLET, FILM COATED in 1 BOTTLE (71335-0970-9)
NDC 71335-0970-09
🏷️ FDA NDC (as labeled) 71335-0970-9 billing pads the package segment with a zero
This package
Contains7-count Pack sizes10 compare ↓
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 →
⚠️
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) 71335-0970-9
Product NDC 71335-0970
11-digit billing NDC 71335097009
RxCUI 197943, 197944
UNII 125OD7737X
Application # ANDA208507
SPL Set ID 3212f121-9428-4186-8f00-accf08bca473
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 2018-01-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance METHOCARBAMOL
GPI-14 75100070000305
GPI class Methocarbamol
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 71335-0970-9 — a 5-4-1 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 package segment → 71335-0970-09. 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

LabelerBryant Ranch Prepack
Application holderREGCON HOLDINGS LLC
FDA applicationANDA208507 (ANDA)
Labeler code71335
First marketedJan 2018
Product typeHuman Prescription Drug
Portfolio4,432 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

📗 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
ImprintB134
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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-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 mgthis 71335-0970-09 Bryant 7 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
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

🏛️
2018
On the market since
Jan 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
71335-0970-00 15 TABLET, FILM COATED in 1 BOTTLE (71335-0970-0) 2018-10-18 Active
71335-0970-01 14 TABLET, FILM COATED in 1 BOTTLE (71335-0970-1) 2018-10-18 Active
71335-0970-02 30 TABLET, FILM COATED in 1 BOTTLE (71335-0970-2) 2018-10-18 Active
71335-0970-03 20 TABLET, FILM COATED in 1 BOTTLE (71335-0970-3) 2018-10-18 Active
71335-0970-04 60 TABLET, FILM COATED in 1 BOTTLE (71335-0970-4) 2018-10-18 Active
71335-0970-05 100 TABLET, FILM COATED in 1 BOTTLE (71335-0970-5) 2018-10-18 Active
71335-0970-06 40 TABLET, FILM COATED in 1 BOTTLE (71335-0970-6) 2018-10-18 Active
71335-0970-07 90 TABLET, FILM COATED in 1 BOTTLE (71335-0970-7) 2018-10-18 Active
71335-0970-08 120 TABLET, FILM COATED in 1 BOTTLE (71335-0970-8) 2018-10-18 Active
71335-0970-09 You're viewing this 7 TABLET, FILM COATED in 1 BOTTLE (71335-0970-9) 2018-10-18 Active

You're viewing the smallest of 10 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-0970-09?
NDC 71335-0970-09 is a 7-count package — 7 tablet, film coated in 1 bottle.
What is the difference between NDC 71335-0970-09 and NDC 71335-0970-01?
Both are Methocarbamol 500 mg Tablet, Film Coated — the drug itself is identical. NDC 71335-0970-09 is the 7-count package, while NDC 71335-0970-01 is the 14 tablets package.
What NDC number is used to bill for this package of Methocarbamol 500 mg Tablet, Film Coated?
Bill NDC 71335-0970-09 — the 11-digit billing format is 71335097009. 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 71335-0970-9, 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: 71335-0970-09, written without dashes as 71335097009. 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 71335-0970-09, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (0970) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) 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 Bryant Ranch Prepack. 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 9 other package presentations of this same product, including 14 tablets (71335-0970-01), 15 tablets (71335-0970-00), 20 tablets (71335-0970-03). 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?
Bryant Ranch Prepack 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 63 words

INDICATIONS AND USAGE Methocarbamol Tablets USP, 500 mg and 750 mg 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 79 words

DOSAGE AND ADMINISTRATION Methocarbamol Tablets USP, 500 mg – Adults: Initial dosage: 3 tablets q.i.d. Maintenance dosage: 2 tablets q.i.d. Methocarbamol Tablets USP, 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 23 words

CONTRAINDICATIONS Methocarbamol Tablets USP, 500 mg and 750 mg are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

⚠️ Warnings 171 words

WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol Tablets USP, 500 mg or 750 mg should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Methocarbamol Tablets USP, 500 mg and 750 mg 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, 500 mg and 750 mg 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 86 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 137 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 Tablets USP, 500 mg and 750 mg should be given to a pregnant woman only if clearly needed.

Safe use Methocarbamol Tablets USP, 500 mg and 750 mg 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, 500 mg and 750 mg 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 26 words

Pediatric Use Safety and effectiveness of Methocarbamol Tablets USP, 500 mg and 750 mg 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 ~1 min read

HOW SUPPLIED Methocarbamol Tablets USP, 750 mg are orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side. They are supplied as follows: NDC 71335-0828-0: 14 TABLET in a BOTTLE NDC 71335-0828-1: 20 TABLET in a BOTTLE NDC 71335-0828-2: 30 TABLET in a BOTTLE NDC 71335-0828-3: 40 TABLET in a BOTTLE NDC 71335-0828-4: 120 TABLET in a BOTTLE NDC 71335-0828-5: 60 TABLET in a BOTTLE NDC 71335-0828-6: 90 TABLET in a BOTTLE NDC 71335-0828-7: 112 TABLET in a BOTTLE NDC 71335-0828-8: 21 TABLET in a BOTTLE NDC 71335-0828-9: 84 TABLET in a BOTTLE Methocarbamol Tablets USP, 500 mg are light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side.

They are supplied as follows: NDC 71335-0970-0: 15 TABLET in a BOTTLE NDC 71335-0970-1: 14 TABLET in a BOTTLE NDC 71335-0970-2: 30 TABLET in a BOTTLE NDC 71335-0970-3: 20 TABLET in a BOTTLE NDC 71335-0970-4: 60 TABLET in a BOTTLE NDC 71335-0970-5: 100 TABLET in a BOTTLE NDC 71335-0970-6: 40 TABLET in a BOTTLE NDC 71335-0970-7: 90 TABLET in a BOTTLE NDC 71335-0970-8: 120 TABLET in a BOTTLE NDC 71335-0970-9: 7 TABLET in a BOTTLE Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). Dispense in tight container.

Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description ~1 min read

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 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 Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration.

The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration.

It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.

💬 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 ↗
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.