Product manufactured by Stat Rx Usa Llc

Application Nr Approved Date Route Status External Links
NDA022304 2008-11-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Nucynta® Is An Opioid Analgesic Indicated For The Relief Of Moderate To Severe Acute Pain In Patients 18 Years Of Age Or Older. (1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Povidones POVIDONES Unresolved
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. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tapentadol Hydrochloride TAPENTADOL HYDROCHLORIDE ZINC20783