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Methocarbamol 100 mg/mL Injection — NDC 70069-0101-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Methocarbamol 100 mg/mL Injection — NDC 70069-101-25 (Billing 70069-0101-25)

by Somerset Therapeutics, LLC · 25 VIAL in 1 CARTON / 10 mL in 1 VIAL

This is a package of Methocarbamol 100 mg/mL Injection from Somerset Therapeutics, LLC, marketed since Jul 2017 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 70069-0101-25
🏷️ FDA NDC (as labeled) 70069-101-25 billing pads the product segment with a zero
This package
Contains10 mL in 1 vial Medicaid pays$2.88 / unit · 12 mo Per package$71.90 / 25 vials · Medicaid Pack sizes3 compare ↓
Main listing for product 70069-101 · Also comes in: 5 vials 70069-101-05 10 vials 70069-101-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 70069-101-25 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70069 labeler · 101 product · 25 package
Package marketed since
Jul 31, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0370069101018, 0370069101100, 0370069101254, 0370069101056
Medicaid fills, this package
2,520 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Mar 21, 2025 — Lack of Assurance of Sterility: Media fill with bacterial contamination (Somerset Therapeutics Private Limited) · FDA recall D-0354-2025
Lots / codes: NDC 70069-101-25; A240304, A240305, A240320, A240322, A240334, A240335, A240340, exp. date 05/2026; A240342, A240347, A240385, A240391, exp. date 06/2026; NDC 70069-101-05; A240326, exp. date 05/2026 · reported Apr 16, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Methocarbamol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70069-101-25
Product NDC 70069-101
11-digit billing NDC 70069010125
NCPDP billing unit ML — per mL (volume)
RxCUI 238175
UNII 125OD7737X
UPC 0370069101018, 0370069101100, 0370069101254, 0370069101056
Application # ANDA207522
SPL Set ID 68dd9c24-4d41-48be-9f54-fceb787bb443
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 2017-07-31
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION
Substance METHOCARBAMOL
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 75100070002010
GPI class Methocarbamol
GCN Seq No 004653
GCN 17881
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 1,000 MG/10 ML
FDB brand name Methocarbamol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004653
  • GCN: 17881
  • GPI-14 (Medi-Span): 75100070002010
  • HICL (First Databank): 001938
  • AHFS class code: 12:20.04.00
  • RxCUI (RxNorm): 238175
Why two NDCs? The FDA registers this code as 70069-101-25 — 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 → 70069-0101-25. 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.

Clinical

Label name METHOCARBAMOL 1,000 MG/10 ML Ingredient Methocarbamol
📗 Our plain-language guide HelloPharmacist
  • It's used along with rest and physical therapy to ease discomfort from sudden, painful muscle and bone conditions. It's an add-on, not a replacement for those other measures.
  • It's best to avoid it. Methocarbamol can add to the effects of alcohol and other sedating medicines. Deaths have been reported with overdose, including when alcohol was involved.
  • Be careful. It can affect your mental and physical abilities. Wait until you know how it affects you before driving or using machinery.
  • Tablets and Atmeksi suspension are taken by mouth several times a day. Usually a higher amount is used for the first couple of days, then less. If you use Atmeksi, shake it well fo...
📖 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.

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 $2.88 $71.90 / 25 vials
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2800 $4.509 / J2800 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)70069-101-25
11-digit billing NDC70069-0101-25
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2800
DescriptorINJECTION, METHOCARBAMOL, UP TO 10 ML
Billing units / pkg0.1 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 10 ML, so one package = 0.1 billing units.
Medicare Part B spend (2026 (Q1))$1,121 · 231 claims · $4.85 per claim (all NDCs under J2800)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70069-0101-05 70069-101-05 5 VIAL in 1 CARTON / 10 mL in 1 VIAL 2017-07-31 — Active
70069-0101-10 70069-101-10 10 VIAL in 1 CARTON / 10 mL in 1 VIAL 2017-07-31 — Active
70069-0101-25 You're viewing this Main listing 25 VIAL in 1 CARTON / 10 mL in 1 VIAL 2017-07-31 — Active

In Medicaid, this is the most-dispensed pack of this product — about 73% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 25 vial in 1 carton / 10 ml in 1 vial.
What NDC number is used to bill for this package of Methocarbamol 100 mg/mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methocarbamol 1000 mg/10mL 00404-9992-10 Henry 1 vial — AP FDA listed —
Robaxin 100 mg/mL 00641-6103-25 Hikma 25 vials — AP FDA listed —
Robaxin 100 mg/mL 00641-6217-25 Hikma 25 vials — AP FDA listed —
Methocarbamol 100 mg/mL 25021-0675-10 Sagent 25 vials — AP FDA listed —
Methocarbamol 100 mg/mL 25021-0689-10 Sagent 25 vials — AP FDA listed —
methocarbamol 100 mg/mL 36000-0302-25 Baxter 25 vials — — FDA listed —
Methocarbamol 100 mg/mL 43598-0839-36 Dr.Reddys 10 vials — AP FDA listed —
Methocarbamol 1000 mg/10mL 55150-0223-10 Eugia 25 vials — AP FDA listed —
Methocarbamol 100 mg/mL 63323-0778-10 Fresenius 25 vials — AP FDA listed —
Methocarbamol 100 mg/mL 68083-0317-25 Gland 25 vials — AP FDA listed —
Methocarbamol 100 mg/mLthis 70069-0101-25 Somerset 25 vials — AP FDA listed —
methocarbamol 100 mg/mL 70436-0149-55 Slate 25 vials — AP FDA listed —
Methocarbamol 100 mg/mL 71288-0716-10 Meitheal 25 vials — AP FDA listed —
Methocarbamol 100 mg/mL 86211-0114-10 JVET 10 vials — AP 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

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 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.

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.

🧪 Avoiding an ingredient? See Methocarbamol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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.

Manufacturer & labeler

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA207522 (ANDA)
Labeler code70069
First marketedJul 2017
Product typeHuman Prescription Drug
Portfolio184 products on file

More NDCs from Somerset Therapeutics, LLC labeler code 70069

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.

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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

INDICATIONS AND USAGE The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug 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 ~3 min read ▾

DOSAGE AND ADMINISTRATION For Intravenous and Intramuscular Use Only . Total adult dosage should not exceed 30 mL (3 vials) a day for more than 3 consecutive days except in the treatment of tetanus. If the condition persists, a like course may be repeated after a drug-free interval of 48 hours.

Dosage and frequency of injection should be based on the severity of the condition being treated and therapeutic response noted. For the relief of symptoms of moderate degree, one dose of 1 gram (one 10 mL vial) may be adequate. Ordinarily this injection need not be repeated, as the administration of the oral form will usually sustain the relief initiated by the injection.

For the severest cases or in postoperative conditions in which oral administration is not feasible, additional doses of 1 gram may be repeated every 8 hours up to a maximum of 3 g/day for no more than 3 consecutive days. Directions for Intravenous Use Methocarbamol injection may be administered undiluted directly into the vein at a maximum rate of three mL per minute. It may also be added to an intravenous drip of Sodium Chloride Injection (Sterile Isotonic Sodium Chloride Solution for Parenteral Use) or five percent Dextrose Injection (Sterile 5 percent Dextrose Solution); one vial given as a single dose should not be diluted to more than 250 mL for I.V. infusion.

AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE. Care should be exercised to avoid vascular extravasation of this hypertonic solution, which may result in thrombophlebitis.

It is preferable that the patient be in a recumbent position during and for at least 10 to 15 minutes following the injection. Directions for Intramuscular Use When the intramuscular route is indicated, not more than five mL (one-half vial) should be injected into each gluteal region. The injections may be repeated at eight hour intervals, if necessary.

When satisfactory relief of symptoms is achieved, it can usually be maintained with tablets. Not Recommended for Subcutaneous Administration. Special Directions for Use in Tetanus There is clinical evidence which suggests that methocarbamol may have a beneficial effect in the control of the neuromuscular manifestations of tetanus.

It does not, however, replace the usual procedure of debridement, tetanus antitoxin, penicillin, tracheotomy, attention to fluid balance, and supportive care. Methocarbamol injection should be added to the regimen as soon as possible. For adults: Inject one or two vials directly into the tubing of the previously inserted indwelling needle.

An additional 10 mL or 20 mL may be added to the infusion bottle so that a total of up to 30 mL (three vials) is given as the initial dose (see PRECAUTIONS ). This procedure should be repeated every six hours until conditions allow for the insertion of a nasogastric tube. Crushed methocarbamol tablets suspended in water or saline may then be given through this tube.

Total daily oral doses up to 24 grams may be required as judged by patient response. For pediatric patients: A minimum initial dose of 15 mg/kg or 500 mg/m 2 is recommended. This dosage may be repeated every six hours if required.

The total dose should not exceed 1.8 g/m 2 for 3 consecutive days. The maintenance dosage may be given by injection into tubing or by I.V. infusion with an appropriate quantity of fluid. See directions for I.V. use.

⛔ Contraindications 96 words ▾

CONTRAINDICATIONS Methocarbamol injection should not be administered to patients with known or suspected renal pathology. This caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. A much larger amount of polyethylene glycol 300 than is present in recommended doses of Methocarbamol injection is known to have increased pre-existing acidosis and urea retention in patients with renal impairment.

Although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. Methocarbamol injection is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.

⚠️ Warnings 155 words ▾

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

Therefore, methocarbamol injection 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 194 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported coincident with the administration of methocarbamol. Some events may have been due to an overly rapid rate of intravenous injection. Body as a whole : Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system : Bradycardia, flushing, hypotension, syncope, thrombophlebitis In most cases of syncope there was spontaneous recovery.

In others, epinephrine, injectable steroids, and/or injectable antihistamines were employed to hasten recovery. 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 light-headedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo The onset of convulsive seizures during intravenous administration of methocarbamol has been reported in patients with seizure disorders.

The psychic trauma of the procedure may have been a contributing factor. Although several observers have reported success in terminating epileptiform seizures with methocarbamol injection, its administration to patients with epilepsy is not recommended (see PRECAUTIONS , General ). Skin and special senses : Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria Other : Pain and sloughing at the site of injection

🔄 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.

🤰 Pregnancy 116 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 injection should be given to a pregnant woman only if clearly needed.

Safe use of methocarbamol injection 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 injection 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 33 words ▾

Pediatric Use Safety and effectiveness of methocarbamol injection in pediatric patients have not been established except in tetanus. See DOSAGE AND ADMINISTRATION , Special Directions for Use in Tetanus, For pediatric patients .

🆘 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) hour, 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 128 words ▾

HOW SUPPLIED Methocarbamol Injection USP, 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution. Total Drug Content: Methocarbamol USP 1,000 mg in 10 mL. NDC Number Methocarbamol mg/mL Volume 70069- 101 -05 100 10 mL 70069- 101 -10 70069- 101 -25 10 mL vials are single dose vials packaged as; - 5 vials per carton, - 10 vials per carton and - 25 vials per carton.

Store at 20 °- 25°C (68°F - 77°F), excursions permitted to 15° - 30°C (59°F - 86°F). [see USP Controlled Room Temperature]. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch Manufactured for: Somerset Therapeutics, LLC.

Somerset, NJ 08873 Made in India Code No.:KR/DRUGS/KTK/28/289/97 ST-MET21/P/00 Revised: August, 2024 1201014

📋 Description 144 words ▾

DESCRIPTION Methocarbamol injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q. s.

The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of 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 injection, USP has a pH between 3.5 and 6.0.

AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE. Molecular Structure

💬 Information for Patients 46 words ▾

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

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General As with other agents administered either intravenously or intramuscularly, careful supervision of dose and rate of injection should be observed. Rate of injection should not exceed 3 mL per minute-i.e., one 10 mL vial in approximately three minutes. Since methocarbamol injection is hypertonic, vascular extravasation must be avoided.

A recumbent position will reduce the likelihood of side reactions. Blood aspirated into the syringe does not mix with the hypertonic solution. This phenomenon occurs with many other intravenous preparations.

The blood may be injected with the methocarbamol, or the injection may be stopped when the plunger reaches the blood, whichever the physician prefers. The total dosage should not exceed 30 mL (three vials) a day for more than three consecutive days except in the treatment of tetanus. Caution should be observed in using the injection form in patients with suspected or known seizure disorders.

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. 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 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.

Carcinogenesis, Mutagenesis Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility. 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 injection should be given to a pregnant woman only if clearly needed. Safe use of methocarbamol injection 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 injection 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). Nursing Mothers Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when methocarbamol injection is administered to a nursing woman. Pediatric Use Safety and effectiveness of methocarbamol injection in pediatric patients have not been established except in tetanus. See DOSAGE AND ADMINISTRATION , Special Directions for Use in Tetanus, For pediatric patients .

🍼 Nursing Mothers 49 words ▾

Nursing Mothers Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when methocarbamol injection is administered to a nursing woman.

🧬 Pharmacokinetics ~1 min read ▾

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) hour, 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.

📄 Package Label / Principal Display Panel 48 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container label – 10 mL Carton label - Pack of 5 Vials Carton label - Pack of 10 Vials Carton label - Pack of 25 Vials Container label (10 mL) Carton Label - 5 Carton label (Pack of 10) Carton label (pack of 25)

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.5K
Units reimbursed last 4 qtrs
28.4K
Gross reimbursed last 4 qtrs
$81.7K
Avg / prescription
$32.42
Avg / unit
$2.8758
Latest quarter Q4 2025
639Rx
Fee-for-service vs managed care ⓘ
89% MCO
Fee-for-service · 280 Rx Managed care · 2,240 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 540 units · 2.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 3,060 units · 95.8 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 5,510 units · 46.8 per 100k residents OH Pennsylvania: 2,880 units · 22.2 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,280 units · 5.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 925 units · 20.4 per 100k residents KY West Virginia: 710 units · 40.1 per 100k residents WV Virginia: 450 units · 5.2 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 100 units · 3.4 per 100k residents KS Arkansas: no data reported AR Tennessee: 4,385 units · 61.5 per 100k residents TN North Carolina: 730 units · 6.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 250 units · 5.5 per 100k residents LA Mississippi: no data reported MS Alabama: 410 units · 8.0 per 100k residents AL Georgia: 4,040 units · 36.6 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 740 units · 2.4 per 100k residents TX Florida: 1,400 units · 6.2 per 100k residents FL
Units reimbursed · per 100k residents
2.495.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nevada 95.8 /100k
2 Tennessee 61.5 /100k
3 Ohio 46.8 /100k
4 West Virginia 40.1 /100k
5 Georgia 36.6 /100k
6 Pennsylvania 22.2 /100k
7 Kentucky 20.4 /100k
8 Alabama 8.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
25 vials this page70069-0101-25 2,520 Rx · $81,702
5 vials70069-0101-05 955 Rx · $13,676
10 vials70069-0101-10 No Medicaid data
Drug total (last 4 qtrs): 3,475 Rx · 39,000 units · $95,378 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.

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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Somerset Therapeutics, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 5 vials (70069-0101-05), 10 vials (70069-0101-10). 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?
Somerset Therapeutics, 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2800 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 70069-0091-01 · Somerset 70069-0121-01 · Somerset →
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.