Source: FDA, National Drug Code (US) Revision Year: 2024
REZENOPY (naloxone hydrochloride) nasal spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy- 3,14- dihydroxymorphinan-6-one hydrochloride with the following structure:
Naloxone hydrochloride, an opioid antagonist, occurs as a white, to slightly off-white powder or almost white crystalline powder and contains two molecules of water of hydration. It is freely soluble in water, in dilute acids, and in strong alkali; slightly soluble in ethanol. pKa values (proton on Nitrogen) are respectively 7.94 at 20°C and 7.82 at 37°C.
Each REZENOPY nasal spray delivers 10 mg naloxone hydrochloride (equivalent to 9 mg of naloxone) in a 0.11 mL aqueous solution.
Inactive ingredients include glycerin, trisodium citrate dihydrate, hydrochloric acid and sodium hydroxide to adjust pH, and purified water. The pH range is 3.9 to 4.5.
| Dosage Forms and Strengths |
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Nasal Spray: 10 mg of naloxone hydrochloride in 0.11 mL in a single dose nasal spray. |
| How Supplied |
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REZENOPY nasal spray 10 mg is supplied as a carton containing two (2) blister packages (NDC 43674-003-02) each with a single spray device. REZENOPY nasal spray is not made with natural rubber latex. Manufactured by: Summit Biosciences Inc., Lexington, KY 40511 |
| Drug | Countries | |
|---|---|---|
| REZENOPY | United States |
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