Application Nr Approved Date Route Status External Links
ANDA204770 2016-11-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Metaxalone Is Indicated As An Adjunct To Rest, Physical Therapy, And Other Measures For The Relief Of Discomforts 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. Metaxalone Does Not Directly Relax Tense Skeletal Muscles In Man.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Carboxymethylcellulose Sodium, Unspecified Form CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM Unresolved
2. Alginic Acid ALGINIC ACID Unresolved GRAS-Generally recognized as safe.
3. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Hydrogenated Castor Oil HYDROGENATED CASTOR OIL Molecular
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metaxalone METAXALONE ZINC471