Methocarbamol

Key Therapeutics
Human Prescription Drug
NDC 70868-910

Methocarbamol is a human prescription drug labeled by 'Key Therapeutics'. National Drug Code (NDC) number for Methocarbamol is 70868-910. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Methocarbamol drug includes Methocarbamol - 500 mg/1 . The currest status of Methocarbamol drug is Active.

Drug Information:

Drug NDC:	70868-910
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Methocarbamol
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Methocarbamol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Key Therapeutics
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	METHOCARBAMOL - 500 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 Jan, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	17 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA040489
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.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Key Therapeutics
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175730 N0000175737
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	125OD7737X
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Muscle Relaxant [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Centrally-mediated Muscle Relaxation [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:	Centrally-mediated Muscle Relaxation [PE] Muscle Relaxant [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
70868-910-10	100 TABLET in 1 BOTTLE (70868-910-10)	01 Jan, 2021	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Methocarbamol Tablets, Usp, 750 Mg

Methocarbamol

Tablet, Film Coated
Marlex Pharmaceuticals, Inc.
NDC: 10135-723

Methocarbamol

Tablet
Camber Pharmaceuticals, Inc.
NDC: 31722-534

Methocarbamol

Injection
Dr.Reddys Laboratories Inc.,
NDC: 43598-839

Product Elements:

Methocarbamol methocarbamol methocarbamol methocarbamol silicon dioxide magnesium stearate povidone k90 starch, corn water sodium starch glycolate type a potato stearic acid 611;o

Drug Interactions:

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.

Indications and Usage:

Indications and 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.

Warnings:

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 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 i n 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 tha Read more...

t methocarbamol therapy does not adversely affect their ability to engage in such activities.

Dosage and Administration:

Dosage and administration methocarbamol, 500 mg â 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.

Contraindications:

Contraindications methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Adverse Reactions:

Adverse reactions adverse reactions reported coincident with the administration of methocarbamol include: body as a whole: anaphylactic reaction, angioneurotic edema, fever, headache cardiovascular system: bradycardia, flushing, hypotension, syncope, thrombophlebitis digestive system: dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting hemic and lymphatic system: leukopenia immune system: hypersensitivity reactions nervous system: amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo skin and special senses: blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

Drug Interactions:

Use in Pregnancy:

Pregnancy teratogenic effects â 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 ).

Pediatric Use:

Pediatric use safety and effectiveness of methocarbamol in pediatric patients below the age of 16 have not been established.

Description:

Description 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 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. 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 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.

Clinical Pharmacology:

Clinical pharmacology the mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (cns) depression. it has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. pharmacokinetics in healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 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 (Â± sd) elimination half-life of methocarbamol in elderly healthy volunteers (mean [Â± sd] age, 69 [Â± 4] years) was slightly prolonged compared to a younger (mean [Â± sd] age, 53. Read more...

3 [Â± 8.8] years), healthy population (1.5 [Â±0.4] hours versus 1.1 [Â± 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 (Â± sd) elimination half-life in these two groups was similar: 1.2 (Â± 0.6) versus 1.1 (Â± 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 (Â± sd) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (Â±1.62) hours and 1.11 (Â± 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.

Pharmacokinetics:

Pharmacokinetics 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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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.

How Supplied:

How supplied methocarbamol tablets, usp 500 mg â white, round, convex face, debossed â611â over bisect and âoâ below bisect on one side and plain on the reverse side. available in: bottles of 100, ndc number 70868-910-10 store at 20Â°â 25Â°c (68Â°â 77Â°f) [see usp controlled room temperature]. dispense in tight container. for more information, call key therapeutics, llc at 1-888-981-8337 manufactured by: oxford pharmaceuticals birmingham, al 35211 manufactured for: key therapeutics flowood, ms 39042 8200011 rev 03/20 r00

Information for Patients:

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.

Package Label Principal Display Panel:

Package label.principal display panel ndc 70868-9 10 - 10 methocarbamol tablets, usp 500 mg rx only 100 tablets each tablet contains: methocarbamol, usp â¦â¦â¦. 500 mg dosage: see package insert for full prescribing information. dispense in a tight container store at 20 to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. manufactured for: key therapeutics flowood, ms 39232 (888)-981-8337 ndc 70868-910-10 methocarbamol tablets, usp 500 mg rx only 100 tablets each tablet contains: methocarbamol, usp â¦â¦â¦. 500 mg dosage: see package insert for full prescribing information. dispense in a tight container store at 20 to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. manufactured for: key therapeutics flowood, ms 39232 (888)-981-8337

Comments/ Reviews:

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