SPL Set ID: fecd2104-5bf3-47ed-a6f0-5c6ebb0a17b4

1 drug(s) with this SPL Set ID

Open DailyMed details

Tapentadol Hydrochloride TAPENTADOL HYDROCHLORIDE
EPIC PHARMA LLC FDA Rx Only

Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R, 2R)-3-(dimethylamino)-1-ethyl-2- methylpropyl] phenol monohydrochloride, and it has the following chemical structure: The molecular weight of tapentadol hydrochloride is 257.80, and the molecular formula is C 14 H 23 NO·HCl. The n-octanol: water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in tapentadol tablets include: colloidal silicon dioxide, copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The film coatings for all tablet strengths contain macrogol/peg 4000, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide; the film coatings for the 50 mg tablets also contain caramel; the film coatings for the 75 mg tablets contain D&C yellow #10 aluminum lake and FD&C red #40/allura red AC aluminum lake; the film coatings for the 100 mg tablets contain FD&C red #40/allura red AC aluminum lake and FD&C yellow #6/sunset yellow FCF aluminum lake. structure-formula.jpg

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