SPL Set ID: 3a53668c-adda-44c2-a743-e79e467437e3

1 drug(s) with this SPL Set ID

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Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE
50 mg/ml Injection
SLATE RUN PHARMACEUTICALS FDA Rx Only

Amiodarone Hydrochloride Injection, USP contains amiodarone hydrochloride, USP (C 25 H 29 I 2 NO 3 •HCl), a class III antiarrhythmic drug. Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone HCl has the following structural formula: Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone Hydrochloride Injection, USP is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the Amiodarone Hydrochloride Injection, USP formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection. Amiodarone Hydrochloride Injection, USP is injection administration. Amiodarone Hydrochloride Injection, USP contains polysorbate 80, which is known to leach di-(2-ethylhexyl)phthalate (DEHP) from polyvinylchloride (PVC) [see Dosage and Administration (2) ] . Amiodarone Structural Formula

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