SPL Set ID: fe9735db-c57e-44a8-bffb-b87a84c2a6f3

1 drug(s) with this SPL Set ID

Open DailyMed details

REXTOVY NALOXONE HYDROCHLORIDE
INTERNATIONAL MEDICATION SYSTEMS, LTD. FDA Rx Only

Naloxone hydrochloride is an opioid antagonist. It is chemically identified as 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. Its molecular formula is C 19 H 21 NO 4 • HCl • 2H 2 O and has a molecular weight of 399.87 g/mol. It has the following structural formula: Naloxone hydrochloride dihydrate occurs as a white to slightly off-white powder. It is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform. REXTOVY Nasal Spray is a prefilled unit-dose intranasal spray. Naloxone hydrochloride is contained as a solution in a stoppered glass vial within the nasal spray device. Each REXTOVY device delivers a single spray containing 4 mg of naloxone hydrochloride (equivalent to 3.6 mg of naloxone) in 0.25 mL of aqueous solution with a pH of 3.5 to 5.0. Inactive ingredients include sodium chloride, sodium hydroxide to adjust pH, and water for injection USP. structure

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