Source: FDA, National Drug Code (US) Revision Year: 2023
NARCAN (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:
C19H21NO4•HCl
M.W. 363.84
Naloxone hydrochloride, an opioid antagonist, occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform.
Each NARCAN Nasal Spray contains a 2 mg or 4 mg single dose of naloxone hydrochloride in a 0.1 mL (100 microliter) aqueous solution.
Inactive ingredients include benzalkonium chloride (preservative), disodium ethylenediaminetetraacetate (stabilizer), sodium chloride, hydrochloric acid to adjust pH, and purified water. The pH range is 3.5 to 5.5.
| Dosage Forms and Strengths |
|---|
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NARCAN Nasal Spray is supplied as a single-dose intranasal spray containing 2 mg or 4 mg of naloxone hydrochloride in 0.1 mL. |
| How Supplied |
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NARCAN Nasal Spray 2 mg is supplied as a carton containing four (4) blister packages (NDC 69547-212-04) each with a single spray device and as a carton containing twenty-four (24) blister packages (NDC 69547-212-24) each with a single spray device. NARCAN Nasal Spray 4 mg is supplied as carton containing two (2) blister packages (NDC 69547-353-02) each with a single spray device. NARCAN Nasal Spray is not made with natural rubber latex. Distributed by Adapt Pharma, Inc., Radnor, PA 19087 USA. |
| Drug | Countries | |
|---|---|---|
| NARCAN | Australia, Brazil, Canada, France, United States |
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