NALOXONE HCI

FDA Drug Profile — NALOXONE HCI

NALOXONE HCI is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including NALOXONE HCI. Available dosage form: injection, solution.

Drug Details

Generic Name
NALOXONE HCI
Brand Names
NALOXONE HCI
Application Number
ANDA070256
Sponsor
HF Acquisition Co. LLC, DBA Health First
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
NALOXONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS & USAGE NARCAN Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN Nasal Spray is not a substitute for emergency medical care. Limitations of Use: Restrict prescription of NARCAN 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.