NDC 61919-610 Methocarbamol

Methocarbamol

NDC Product Code 61919-610

NDC CODE: 61919-610

Proprietary Name: Methocarbamol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Methocarbamol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • 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.
  • 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.
  • 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.
  • 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.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
G;500
Score: 2

NDC Code Structure

NDC 61919-610-30

Package Description: 30 TABLET, COATED in 1 BOTTLE

NDC 61919-610-40

Package Description: 40 TABLET, COATED in 1 BOTTLE

NDC 61919-610-60

Package Description: 60 TABLET, COATED in 1 BOTTLE

NDC 61919-610-90

Package Description: 90 TABLET, COATED in 1 BOTTLE

NDC Product Information

Methocarbamol with NDC 61919-610 is a a human prescription drug product labeled by Directrx. The generic name of Methocarbamol is methocarbamol. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Directrx

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Methocarbamol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • METHOCARBAMOL 500 mg/1
  • METHOCARBAMOL 500 mg/1
  • METHOCARBAMOL 500 mg/1
  • METHOCARBAMOL 500 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Centrally-mediated Muscle Relaxation - [PE] (Physiologic Effect)
  • Muscle Relaxant - [EPC] (Established Pharmacologic Class)
  • Centrally-mediated Muscle Relaxation - [PE] (Physiologic Effect)
  • Muscle Relaxant - [EPC] (Established Pharmacologic Class)
  • Centrally-mediated Muscle Relaxation - [PE] (Physiologic Effect)
  • Muscle Relaxant - [EPC] (Established Pharmacologic Class)
  • Centrally-mediated Muscle Relaxation - [PE] (Physiologic Effect)
  • Muscle Relaxant - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Directrx
Labeler Code: 61919
FDA Application Number: ANDA209312 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-18-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Methocarbamol

Methocarbamol is pronounced as (meth oh kar' ba mole)

Why is methocarbamol medication prescribed?
Methocarbamol is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuri...
[Read More]

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Methocarbamol Product Label Images

Methocarbamol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.The chemical name of methocarbamol is 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.[str]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.Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration.Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side.Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side.Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide

Clinical Pharmacology

The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.PharmacokineticsIn 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.

Special Populations

Elderly

The mean (± SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), healthy population (1.5 (± 0.4) hours versus 1.1 (± 0.27) hours, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).
Renally impaired

The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (± SD) elimination half-life in these two groups was similar: 1.2 (± 0.6) versus 1.1 (±0.3) hours, respectively.
Hepatically impaired

In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (± SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (± 1.62) hours and 1.11 (± 0.27) hours, respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.

Indications & Usage

Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

Contraindications

Methocarbamol tablets are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Warnings

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 tablets 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 AlertnessMethocarbamol 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.

Precautions

INFORMATION FOR PATIENTSPatients 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 INTERACTIONSSee WARNINGS and PRECAUTIONSfor 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 & OR LABORATORY TEST INTERACTIONSMethocarbamol 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.CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITYLong-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.PREGNANCYTeratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol tablets should be given to a pregnant woman only if clearly needed.
Safe use of methocarbamol tablet 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 WARNINGS).
NURSING MOTHERSMethocarbamol 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 tablets are administered to a nursing woman.PEDIATRIC USESafety and effectiveness of methocarbamol tablets in pediatric patients below the age of 16 have not been established.

Adverse Reactions

Adverse reactions reported coincident with the administration of methocarbamol include:Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headacheCardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitisDigestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomitingHemic and lymphatic system: LeukopeniaImmune system: Hypersensitivity reactionsNervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures(including grand mal), vertigoSkin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, UrticariaTo report SUSPECTED ADVERSE REACTIONS, contact Granules USA, Inc. at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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.TreatmentManagement 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 Tablets, USP 500 mg – Adults:

Initial dosage: 3 tablets 4 times daily

Maintenance dosage: 2 tablets 4 times daily

Methocarbamol Tablets, USP 750 mg – Adults:

Initial dosage: 2 tablets 4 times daily

Maintenance dosage: 1 tablet every 4 hours or 2 tablets three times daily
Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

How Supplied

Methocarbamol tablets, USP 500 mg are light orange colored, roundshaped film coated tablets debossed with "G" above the score line onone side and "500" on other side.They are supplied as followsBottles of 24 tabletsBottles of 100 tabletsBottles of 500 tabletsBottles of 1000 tabletsMethocarbamol tablets, USP 750 mg are light orange colored, capletshaped film coated tablets debossed with "G" on one side and"750" on other side.Bottles of 24 tabletsBottles of 100 tabletsBottles of 500 tabletsBottles of 1000 tablets
Store between 20ºC and 25ºC (68ºF and 77º F)
[see USP Controlled Room Temperature].Dispense in tight container.
Manufactured for:
Granules USA, Inc.Parsippany, NJ 07054Toll-free: 1-877-770-3183
Manufactured by:
Granules India LimitedHyderabad-500 081Made in India
Issued: January 2017

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