SPL Set ID: d5937f27-88c7-4c4a-801e-4c8945008982

1 drug(s) with this SPL Set ID

Open DailyMed details

Dabigatran Etexilate DABIGATRAN ETEXILATE
150 mg Capsule
NORTHSTAR RXLLC FDA Rx Only

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is N-[[2-[[[4-[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-β-alanine ethyl ester, methanesulfonate. The empirical formula is C 34 H 41 N 7 O 5 .CH 3 SO 3 H and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a yellow-white to yellow color powder. Sparingly soluble in methanol. Dabigatran etexilate capsules are supplied in 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), along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, sugar spheres (sucrose and corn starch), talc and tartaric acid. The capsule shell is composed of iron oxide red, iron oxide yellow, hypromellose and titanium dioxide. The capsules are printed with black ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. dabigartanstructure

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