Methocarbamol

Aphena Pharma Solutions - Tennessee, Llc
Human Prescription Drug
NDC 71610-242

Methocarbamol is a human prescription drug labeled by 'Aphena Pharma Solutions - Tennessee, Llc'. National Drug Code (NDC) number for Methocarbamol is 71610-242. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Methocarbamol drug includes Methocarbamol - 750 mg/1 . The currest status of Methocarbamol drug is Active.

Drug Information:

Drug NDC:	71610-242
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:	Aphena Pharma Solutions - Tennessee, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Film Coated
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 - 750 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 Oct, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 Jan, 2026
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:	ANDA208507
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, 2023
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:	Aphena Pharma Solutions - Tennessee, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	197944
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
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
71610-242-53	60 TABLET, FILM COATED in 1 BOTTLE (71610-242-53)	22 Feb, 2019	N/A	No
71610-242-70	120 TABLET, FILM COATED in 1 BOTTLE (71610-242-70)	22 Feb, 2019	N/A	No
71610-242-80	180 TABLET, FILM COATED in 1 BOTTLE (71610-242-80)	22 Feb, 2019	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 starch, corn hydroxypropyl cellulose, low substituted sodium starch glycolate type a potato povidone sodium lauryl sulfate silicon dioxide stearic acid magnesium stearate water hypromelloses titanium dioxide propylene glycol d&c yellow no. 10 fd&c yellow no. 6 polysorbate 20 hydroxypropyl cellulose, unspecified orange b135

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 tablets usp, 500 mg and 750 mg 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.

Warnings:

Warnings since methocarbamol may possess a general cns depressant effect, patients receiving methocarbamol tablets usp, 500 mg or 750 mg should be cautioned about combined effects with alcohol and other cns depressants. safe use of methocarbamol tablets usp, 500 mg and 750 mg 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 usp, 500 mg and 750 mg 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 ).

Dosage and Administration:

Dosage and administration methocarbamol tablets usp, 500 mg â adults: initial dosage: 3 tablets q.i.d. maintenance dosage: 2 tablets q.i.d. methocarbamol tablets usp, 750 mg â adults: initial dosage: 2 tablets q.i.d. maintenance dosage: 1 tablet q.4h. or 2 tablets t.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 tablets usp, 500 mg and 750 mg are 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, and rash, urticarial.

Drug Interactions:

Pediatric Use:

Pediatric use safety and effectiveness of methocarbamol tablets usp, 500 mg and 750 mg in pediatric patients below the age of 16 have not been established.

Overdosage:

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

Description:

Description methocarbamol tablets 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 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. methocarbamol tablets usp, 500 mg is available as a light orange colored, round, film- coated tablets, engraved with 'b134' on one side and scored on the other side, containing 500 mg of methocarbamol, usp for oral administration. the inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. methocarbamol tablets usp, 500 mg contains opadry 13h530000 (orange) (hypromellose, titanium dioxide, propylene glycol, fd&c yellow #6/sunset yellow fcf aluminum lake, polysorbate 20) as coating material. methocarbamol tablets usp, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'b135' on one side and plain on the other side, containing 750 mg of methocarbamol, usp for oral administration. the inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. methocarbamol tablets usp, 750 mg contains opadry 13h530001 (orange) (hypromellose, titanium dioxide, propylene glycol, d&c yellow #10 aluminum lake, fd&c yellow #6/sunset yellow fcf aluminum lake, polysorbate 20) as coating material. the structural formula for methocarbamol tablets 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 3 - (2-methoxyphenoxy) -1, 2- propanediol 1- carbamate and has the empirical formula c11 h15 no5. its molecular weight is 241.24.

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:

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:

C arcinogenesis, 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 are light orange colored, round, film-coated tablets, engraved with 'b134' on one side and scored on the other side. they are supplied as follows: bottles of 100 ndc 10135-0664-01 bottles of 500 ndc 10135-0664-05 methocarbamol tablets usp, 750 mg are orange colored, capsule shaped, film coated tablets, engraved with 'b135' on one side and plain on the other side. they are supplied as follows: bottles of 100 ndc 10135-0665-01 bottles of 500 ndc 10135-0665-05 store at controlled room temperature, between 20Â°c and 25Â°c (68Â°f and 77Â°f). dispense in tight container. manufactured for / distributed by: marlex pharmaceuticals, inc. new castle, de 19720 rev. 09/18b

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:

Principal display panel - 750 mg ndc 71610-242 - methocarbamol, usp 750 mg tablets - rx only bottle label 750 mg

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.