FDA label
What is naloxone used for?
The FDA-approved uses of naloxone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or know...”
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Naloxone Hydrochloride, injection, solution
Indications and Usage, quoted from the label by Hospira, Inc. (ANDA070256). Cross-references to other label sections are left out.
Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage.
Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock ).
Source: DailyMed label, set id 8535cc84-ad4a-4d67-8480-fb5a2e3406f8, version 35, effective May 27, 2026. NDC 0409-1215, one of 40 listings for this product.
Naloxone Hydrochloride, injection
Indications and Usage, quoted from the label by International Medication Systems, Limited (ANDA072076). Cross-references to other label sections are left out.
Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including, propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine and butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage.
Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock. (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).
Source: DailyMed label, set id 236349ef-2cb5-47ca-a3a5-99534c3a4996, version 7, effective December 16, 2024. NDC 76329-1469, one of 19 listings for this product.
Naloxone Hcl, spray
Indications and Usage, quoted from the label by HF Acquisition Co LLC, DBA HealthFirst (ANDA211951). Cross-references to other label sections are left out.
Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
Naloxone HCl Nasal Spray is not a substitute for emergency medical care.
Limitations of Use:
Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
Source: DailyMed label, set id f8fcda15-8ba6-e66a-e053-6294a90a385c, version 2, effective January 28, 2024. NDC 51662-1620, one of 3 listings for this product.
Questions
What is naloxone used for?
The FDA label says: “Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or know...”
What drug class is naloxone?
FDA lists naloxone in the Opioid Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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