SPL Set ID: 004de5a4-80f8-4040-a6ea-be5e99352a36

1 drug(s) with this SPL Set ID

Open DailyMed details

TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE
#40 100 mg Extended-release
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis -2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets, USP contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol. Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol. Meets USP dissolution test 4. tramadol-structure

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