NDC 80425-0283 Methocarbamol
What is NDC 80425-0283?
The NDC code 80425-0283 is assigned by the FDA to the product Methocarbamol which is a human prescription drug product labeled by Advanced Rx Pharmacy Of Tennessee, Llc. The product's dosage form is tablet and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 80425-0283-1 30 tablet in 1 bottle , 80425-0283-2 60 tablet in 1 bottle , 80425-0283-3 90 tablet in 1 bottle , 80425-0283-4 120 tablet in 1 bottle , 80425-0283-5 180 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Methocarbamol?
Methocarbamol is used to treat muscle spasms/pain. It is usually used along with rest, physical therapy, and other treatment. It works by helping to relax the muscles.
|Color(s)||WHITE (C48325) |
|Shape||ROUND (C48348) |
|Size(s)||19 MM |
NDC Code 80425-0283-1
Package Description: 30 TABLET in 1 BOTTLE
NDC Code 80425-0283-2
Package Description: 60 TABLET in 1 BOTTLE
NDC Code 80425-0283-3
Package Description: 90 TABLET in 1 BOTTLE
NDC Code 80425-0283-4
Package Description: 120 TABLET in 1 BOTTLE
NDC Code 80425-0283-5
Package Description: 180 TABLET in 1 BOTTLE
What are Methocarbamol Active Ingredients?
- METHOCARBAMOL 500 mg/1 - A centrally acting muscle relaxant whose mode of action has not been established. It is used as an adjunct in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1206)
Methocarbamol Active Ingredients UNII Codes
- METHOCARBAMOL (UNII: 125OD7737X)
- METHOCARBAMOL (UNII: 125OD7737X) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 197943 - methocarbamol 500 MG Oral Tablet
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Methocarbamol Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Methocarbamol Tablets, USP 500 mg
Methocarbamol Tablets, USP, 500 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.
The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24.
The structural formula is shown below.
Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.
Each tablet, for oral administration, contains either 500 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid.
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.
In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/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.
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).
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.
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.
Indications & Usage
Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties.
Methocarbamol does not directly relax tense skeletal muscles in man.
Methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Warnings And Precautions
Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol tablets should be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS, PREGNANCY).
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.
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.
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.
Teratogenic Effects – Pregnancy Category C
Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol should be given to a pregnant woman only if clearly needed.
Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol 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).
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 is administered to a nursing woman.
Safety and effectiveness of methocarbamol in pediatric patients below the age of 16 have not been established.
Adverse reactions reported coincident with the administration of methocarbamol include:
Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache
Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis
Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting
Hemic and lymphatic system: Leukopenia
Immune system: Hypersensitivity reactions
Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo
Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria
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.
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.
Dosage & Administration
Methocarbamol, 500 mg — Adults: Initial dosage: 3 tablets q.i.d.
Maintenance dosage: 2 tablets q.i.d.
Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
How Supplied/Storage And Handling
Methocarbamol Tablets, USP 500 mg — white, round, convex face, debossed “611” over bisect and “O” below bisect on one side and plain on the reverse side. Available in:
Bottles of 30 NDC: 80425-0283-01
Bottles of 60 NDC: 80425-0283-02
Bottles of 90 NDC: 80425-0283-03
Bottles of 120 NDC: 80425-0283-04
Bottles of 180 NDC: 80425-0283-05
Store at 20°– 25°C (68°– 77°F) [See USP Controlled Room Temperature].
Dispense in tight container.
For more information, call Key Therapeutics, LLC at 1-888-981-8337
Birmingham, AL 35211
Flowood, MS 39042
Advanced Rx Pharmacy of Tennessee, LLC
* Please review the disclaimer below.