Chlorzoxazone
Aurobindo Pharma Limited
Human Prescription Drug
NDC 59651-306Chlorzoxazone is a drug for further processing labeled by 'Aurobindo Pharma Limited'. National Drug Code (NDC) number for Chlorzoxazone is 59651-306. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Chlorzoxazone drug includes Chlorzoxazone - 500 mg/1 . The currest status of Chlorzoxazone drug is Active.
Drug Information:
| Drug NDC: | 59651-306 |
| 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: | Chlorzoxazone |
| 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: | Chlorzoxazone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aurobindo Pharma Limited |
| 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: | CHLORZOXAZONE - 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: | 03 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Dec, 2024 |
| 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: | ANDA089853 |
| 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: | Aurobindo Pharma Limited
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197502
|
| 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. |
| 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: | H0DE420U8G
|
| 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 |
|---|
| 59651-306-01 | 100 TABLET in 1 BOTTLE (59651-306-01) | 03 Aug, 2020 | N/A | No |
| 59651-306-05 | 500 TABLET in 1 BOTTLE (59651-306-05) | 03 Aug, 2020 | 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. |
Product Elements:
Chlorzoxazone chlorzoxazone chlorzoxazone chlorzoxazone lactose monohydrate microcrystalline cellulose fd&c yellow no. 6 d&c red no. 27 hypromellose 2910 (3 mpa.s) polysorbate 80 alcohol starch, corn sodium starch glycolate type a potato magnesium stearate light orange to orange flat, hexagonal n;500
Indications and Usage:
Indications chlorzoxazone 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. chlorzoxazone does not directly relax tense skeletal muscles in man.
Warnings:
Warnings serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. the mechanism is unknown but appears to be idiosyncratic and unpredictable. factors predisposing patients to this rare event are not known. patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g., ast, alt, alkaline phosphatase and bilirubin.) the concomitant use of alcohol or other central nervous system depressants may have an additive effect. usage in pregnancy the safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. therefore, it should be used in w
Read more...omen of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks.
Dosage and Administration:
Dosage and administration usual adult dosage one tablet three or four times daily. if adequate response is not obtained with this dose, it may be increased to one and one-half tablets (750 mg) three or four times daily. as improvement occurs dosage can usually be reduced.
Contraindications:
Contraindications chlorzoxazone is contraindicated in patients with known intolerance to the drug.
Adverse Reactions:
Adverse reactions chlorzoxazone containing products are usually well tolerated. it is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. drowsiness, dizziness, lightheadedness, malaise, or over-stimulation may be noted by an occasional patient. rarely, allergic type skin rashes, petechiae, or ecchymoses may develop during treatment. angioneurotic edema or anaphylactic reactions are extremely rare. there is no evidence that the drug will cause renal damage. rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. this finding is of no known clinical significance. to report suspected adverse events, contact aurobindo pharma usa, inc. at 1-866-850-2876 or fda at 1-800- fda-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Overdosage:
Overdosage symptoms initially, gastrointestinal disturbances such as nausea, vomiting, or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. the deep tendon reflexes may be decreased or absent. the sensorium remains intact, and there is no peripheral loss of sensation. respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. the blood pressure is lowered, but shock has not been observed. treatment gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. thereafter, treatment is entirely supportive. if respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube. hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. cholinergic drugs or analeptic drugs are of no value and should not be used.
Description:
Description chlorzoxazone usp is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. its chemical name is 5-chloro-2-benzoxazolinone, and its structural formula is: chlorzoxazone,usp is a white or practically white, practically odorless, crystalline powder. chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. chlorzoxazone tablets contain the inactive ingredients -lactose monohydrate usnf, microcrystalline cellulose usnf, fd&c yellow 6/sunset yellow fcf aluminium lake, d&c red 27/phloxine aluminium lake, hypromellose usp (a) binder solution hypromellose usp (b), polysarbate 80 usnf, ethanol (96%v/v). extragranrular pregelatinized starch usnf, sodium starch glycolate usnf, magnesium stearate usnf. fda approved dissolution method differs from that of the usp. structure
Clinical Pharmacology:
Clinical pharmacology chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. the clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.
How Supplied:
How supplied chlorzoxazone tablets, usp 500 mg are available as light orange to orange round shaped, flat hexagonal, beveled debossed with n on one side of break line and 500 on other side of break line and plain on other side. bottles of 100 with child-resistant closure ndc 59651-306-01 bottles of 500 ndc 59651-306-05 store at controlled room temperature 15°- 30°c (59°-86° f). dispense contents with a child-resistant closure (as required) and in a tight container as defined in the usp/nf. keep out of the reach of children. distributed by: aurobindo pharma usa, inc. 279 princeton-hightstown road east windsor, nj 08520 manufactured by: aurobindo pharma limited hyderabad-500 032, india revised: 11/2021
Package Label Principal Display Panel:
Package label-principal display panel - 500 mg (100 tablets bottle) ndc 59651-306-01 rx only chlorzoxazone tablets, usp 500 mg aurobindo 100 tablets chlorzoxazone-fig1.jpg