Application Nr Approved Date Route Status External Links
NDA200534 2010-10-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Oxycodone Hydrochloride Capsule Is An Opioid Analgesic, Indicated For The Management Of Moderate To Severe Acute And Chronic Pain Where Use Of An Opioid Analgesic Is Appropriate. Oxycodone Hydrochloride Is An Opioid Agonist Indicated For The Management Of Moderate To Severe Acute And Chronic Pain Where The Use Of An Opioid Analgesic Is Appropriate. (1)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. 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. Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE ZINC403533

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