SPL Set ID: baafb5be-ffe6-4755-a7ab-817b3c9b222d

1 drug(s) with this SPL Set ID

Open DailyMed details

Dabigatran Etexilate DABIGATRAN ETEXILATE
86.48 mg Capsule
MYLAN PHARMACEUTICALS INC. FDA Rx Only

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is Ethyl 3-{[(2-{[(4-{[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1 H -benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propanoate, monomethanesulfonate. The empirical formula is C 34 H 41 N 7 O 5 •CH 4 O 3 S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, crospovidone, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 150 mg capsules also contain black iron oxide and red iron oxide. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dabigatran Etexilate Mesylate

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