NDC 69528-0701-05 — ATMEKSI methocarbamol 750 mg/5mL, 150 mL

🆔 Identity & classification

FDA NDC (as labeled) 69528-701-05

Product NDC 69528-701

11-digit billing NDC 69528070105

NCPDP billing unit ML — per mL (volume)

RxCUI 2729335, 2729341

UNII 125OD7737X

Application # NDA219843

SPL Set ID 62de7345-613b-4838-96e5-aceca3cea6b2

Established class (EPC) Muscle Relaxant

Physiologic effect Centrally-mediated Muscle Relaxation

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2025-12-22

Route ORAL

Dosage form SUSPENSION

Substance METHOCARBAMOL

GPI-14 75100070001820

GCN Seq No 088073

GCN 58157

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 ATMEKSI 750 MG/5 ML SUSPENSION

FDB brand name Atmeksi

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 69528-701-05 — 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 → 69528-0701-05. 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

LabelerRosemont Pharmaceuticals LLC

Application holderROSEMONT PHARMACEUTICALS HOLDINGS INC

FDA applicationNDA219843 (NDA)

Labeler code69528

First marketedDec 2025

Product typeHuman Prescription Drug

Portfolio4 products on file

🔎 All NDCs from Rosemont Pharmaceuticals LLC

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 ATMEKSI 750 MG/5 ML SUSPENSION Ingredient Methocarbamol

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Methocarbamol — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Methocarbamol (20 interactions) — ranked by severity →

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

FlavorFruit

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 K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
UNII 6M3P64V0NC
A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Atmeksi 750 mg/5mLthis 69528-0701-05	Rosemont	150 ml	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

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

First FDA approval

Jul 2025

📍

2026

Currently FDA-listed

1 year listed

🛡️

2044

Latest patent/protection listed

not a guaranteed launch date

🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Jul 30, 2025 RLD RS ⏳ ~18 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 12390439 — method of use (U-4253)

2025 2027 2029 2031 2033 2035 2037 2039 2041 2043

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)

Patent	Type	Use code	Expires
US 12390439 ↗	Method of use	U-4253	Oct 9, 2044

Common questions

Is there a generic version of ATMEKSI 750 MG/5 ML SUSPENSION?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ATMEKSI 750 MG/5 ML SUSPENSION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2044 — an estimate, not a guaranteed launch date.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
69528-0701-05 You're viewing this	150 mL in 1 BOTTLE (69528-701-05)	2026-01-15	Active

🧭 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 69528-701-05, 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: 69528-0701-05, written without dashes as 69528070105. 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 69528-0701-05, the first segment (69528) is the labeler code FDA assigned to Rosemont Pharmaceuticals LLC; the middle segment (0701) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Rosemont Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Rosemont Pharmaceuticals 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 107 words ▾

1 INDICATIONS AND USAGE ATMEKSI (methocarbamol) oral suspension is a muscle relaxant indicated as: an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older.

1.1Acute, painful musculoskeletal conditions. ATMEKSI is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Adults Initial dosage: 1,500 mg (10 mL) 4 times daily Maintenance dosage: 750 mg (5 mL) every 4 hours or 1,500 mg (10 mL) 3 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.

2.1Important Dosage and Administration Instructions Initial dosage: 1,500 mg (10 mL) 4 times daily Maintenance dosage: 750 mg (5 mL) every 4 hours or 1,500 mg (10 mL) 3 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.

Inform the patient to shake the drug product for at least 30 seconds to ensure it is uniform before administration.

2.1Important Dosage and Administration Instructions Initial dosage: 1,500 mg (10 mL) 4 times daily Maintenance dosage: 750 mg (5 mL) every 4 hours or 1,500 mg (10 mL) 3 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.

Inform the patient to shake the drug product for at least 30 seconds to ensure it is uniform before administration.

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Suspension: 750 mg/5 mL of methocarbamol as a white to off-white suspension with a fruit flavor oral suspension: 750 mg/5 mL

⛔ Contraindications 62 words ▾

4 CONTRAINDICATIONS

4.1Hypersensitivity ATMEKSI is contraindicated in patients hypersensitive to methocarbamol or to any of the oral suspension components. Hypersensitivity to ATMEKSI or any component in the product ( 4.1 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol ( 5.1 ) ATMEKSI may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle ( 5.2 )

5.1CNS Depressants and Alcohol Use ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol. Patients receiving ATMEKSI (methocarbamol) Oral Suspension should be cautioned about combined effects with alcohol and other CNS depressants [ see Drug Interactions (7.1) ].

5.2Use in Activities Requiring Mental Alertness ATMEKSI 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.

5.1CNS Depressants and Alcohol Use ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol. Patients receiving ATMEKSI (methocarbamol) Oral Suspension should be cautioned about combined effects with alcohol and other CNS depressants [ see Drug Interactions (7.1) ].

5.2Use in Activities Requiring Mental Alertness ATMEKSI 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 ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reaction is described elsewhere in the labeling: Interactions with CNS Depressants and Alcohol [ see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of methocarbamol have been identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions reported 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. Body: Anaphylactic reaction, angioneurotic edema, fever, headache ( 6 ) Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis ( 6 ) Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting ( 6 ) Hemic and lymphatic system: Leukopenia ( 6 ) Immune system: Hypersensitivity reactions ( 6 ) Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo ( 6 ) Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash and urticaria ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rosemont Pharmaceuticals, LLC. at 1-844-638-2235 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS ATMEKSI may inhibit the effect of pyridostigmine bromide. Patients with myasthenia gravis should be monitored closely for symptoms of myasthenia gravis such as weakness. If symptoms of myasthenia gravis are observed, treatment with ATMEKSI should be stopped immediately ( 7.2 ) Laboratory test interference: Methocarbamol may cause color interference in the following screening tests: 5-hydroxyindoleacetic acid (using nitrosonaphthol reagent) and VMA (Giltow method) ( 7.3 )

7.1CNS drugs and alcohol ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol [ see Warnings and Precautions (5.1) ].

7.2Pyridostigmine Bromide ATMEKSI may inhibit the effect of pyridostigmine bromide. Patients with myasthenia gravis should be monitored closely for symptoms of myasthenia gravis such as weakness. If symptoms of myasthenia gravis are observed, treatment with ATMEKSI should be stopped immediately.

7.3Drug/Laboratory Test Interactions ATMEKSI may cause 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.

7.1CNS drugs and alcohol ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol [ see Warnings and Precautions (5.1) ].

7.2Pyridostigmine Bromide ATMEKSI may inhibit the effect of pyridostigmine bromide. Patients with myasthenia gravis should be monitored closely for symptoms of myasthenia gravis such as weakness. If symptoms of myasthenia gravis are observed, treatment with ATMEKSI should be stopped immediately.

7.3Drug/Laboratory Test Interactions ATMEKSI may cause 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.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ATMEKSI and any potential adverse effects on the breastfed infant from methocarbamol or the underlying maternal condition .

8.1Pregnancy Risk Summary Limited data from case reports over decades of use with methocarbamol during pregnancy have not identified an increased risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized patients is 2 to 4% and 15 to 20% respectively.

8.2Lactation Risk Summary There are no data on the presence of methocarbamol or its metabolites in human milk, the effects on a breastfed infant or the effects on milk production. Methocarbamol and/or its metabolite are present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ATMEKSI and any potential adverse effects on the breastfed infant from ATMEKSI or the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of methocarbamol oral suspension in pediatric patients below the age of 16 have not been established.

8.1Pregnancy Risk Summary Limited data from case reports over decades of use with methocarbamol during pregnancy have not identified an increased risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized patients is 2 to 4% and 15 to 20% respectively.

8.2Lactation Risk Summary There are no data on the presence of methocarbamol or its metabolites in human milk, the effects on a breastfed infant or the effects on milk production. Methocarbamol and/or its metabolite are present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ATMEKSI and any potential adverse effects on the breastfed infant from ATMEKSI or the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of methocarbamol oral suspension in pediatric patients below the age of 16 have not been established.

🆘 Overdosage 163 words ▾

10 OVERDOSAGE Clinical Presentation Deaths have been reported with an overdose of methocarbamol alone and when methocarbamol was used with other CNS depressants, including alcohol. Limited information is available on the acute toxicity of methocarbamol. Symptoms of overdose include the following: respiratory depression, nausea, drowsiness, blurred vision, hypotension, seizures, coma, and death.

Other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) can have an additive effect, even when taken at recommended dosages. Treatment of Overdose The standard of treatment is supportive care, including monitoring for CNS and respiratory depression and managing airway as needed, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. Hypotension should be treated with intravenous fluids and vasopressors as needed.

Gastrointestinal decontamination procedures (including emesis) should generally be avoided because aspiration may result from CNS depression and seizures. Extracorporeal elimination such as hemodialysis or plasmapheresis has no proven clinical benefit. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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.

12.3Pharmacokinetics Absorption After oral administration in healthy volunteers, ATMEKSI is rapidly absorbed with a median Tmax of 0.66 hours. Food decreases the extent and delays the rate of absorption of methocarbamol. In the presence of food, the Cmax is decreased by 51% and the AUC is decreased by 31%.

The median Tmax is delayed to 1.6 hours. Distribution Methocarbamol demonstrates moderate binding to plasma proteins, typically ranging from 46% to 50%. Elimination In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and

0.80L/h/kg. The mean plasma elimination half-life of ATMEKSI in healthy volunteers is approximately 1.3 hours and 1.5 hours when administered with or without food. Metabolism Methocarbamol is metabolized via dealkylation and hydroxylation.

Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Excretion Small amounts of unchanged methocarbamol also are excreted in the urine.

Specific Populations Geriatric Patients 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). Pediatric Patients Safety and effectiveness of methocarbamol oral suspension in pediatric patients below the age of 16 have not been established.

Patients with Renal Impairment 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. Patients with Hepatic Impairment 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.

12.1Mechanism of Action 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.

12.3Pharmacokinetics Absorption After oral administration in healthy volunteers, ATMEKSI is rapidly absorbed with a median Tmax of 0.66 hours. Food decreases the extent and delays the rate of absorption of methocarbamol. In the presence of food, the Cmax is decreased by 51% and the AUC is decreased by 31%.

The median Tmax is delayed to 1.6 hours. Distribution Methocarbamol demonstrates moderate binding to plasma proteins, typically ranging from 46% to 50%. Elimination In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and

0.80L/h/kg. The mean plasma elimination half-life of ATMEKSI in healthy volunteers is approximately 1.3 hours and 1.5 hours when administered with or without food. Metabolism Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Excretion Small amounts of unchanged methocarbam…

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ATMEKSI (methocarbamol) Oral Suspension contains 750 mg/5 mL methocarbamol. It is a white to off-white suspension with a fruit flavor and is supplied in bottles of 150 mL with a child-resistant closure (NDC 69528-701-05).

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Keep out of reach and sight of children.

16.1How Supplied ATMEKSI (methocarbamol) Oral Suspension contains 750 mg/5 mL methocarbamol. It is a white to off-white suspension with a fruit flavor and is supplied in bottles of 150 mL with a child-resistant closure (NDC 69528-701-05).

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Keep out of reach and sight of children.

📋 Description 124 words ▾

11 DESCRIPTION ATMEKSI (methocarbamol) Oral Suspension is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is (±)1,2-Propanediol, 3-(2-methoxyphenoxy)-, 1-carbamate, or (±)-3-(o-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24g/mol.

The structural formula is shown below: Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n -hexane. ATMEKSI (methocarbamol) Oral Suspension is a white to off-white suspension with a fruit flavor and a pH range of 3.2 – 4.8. ATMEKSI (methocarbamol) Oral Suspension contains the following inactive ingredients: citric acid monohydrate, glycerin, magnesium aluminum silicate, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sucralose and fruit flavor. formula

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

sedative: A substance with a calming effect that can also cause drowsiness.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

additive effect: When two medicines that do the same thing are taken together and their effects add up to a larger combined effect.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

conjunctivitis: Redness and irritation of the thin lining over the white of the eye, often called pink eye.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diplopia: Double vision, or seeing two images of a single object.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

pruritus: Itching of the skin.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

Tmax: The time after a dose when a medicine reaches its highest level in the blood.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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ATMEKSI methocarbamol 750 mg/5mL Suspension, 150 mL

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