SPL Set ID: d911b4cf-eec4-43f8-aa64-cc60cfc901b9

1 drug(s) with this SPL Set ID

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Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE
ADVAGEN PHARMA LIMITED FDA Rx Only

Amiodarone Hydrochloride Tablets (amiodarone HCl) is an antiarrhythmic drug, available for oral administration as mottled pink, round, flat faced bevelled edge tablets containing 100 mg, 200 mg and 400 mg of amiodarone hydrochloride. The inactive ingredients present are colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Red #40 Al Lake and magnesium stearate. Amiodarone Hydrochloride Tablets is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]- 3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows: C 25 H 29 I 2 NO 3 • HCl Molecular Weight: 681.8 Amiodarone HCl is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. The Product meets USP Dissolution Test 2. Structure

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