Label: NALOXONE spray

  • NDC Code(s): 43674-003-02
  • Packager: Summit Biosciences Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 12, 2023

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  • PATIENT PACKAGE INSERT

    Naloxone 10 mg

  • INDICATIONS & USAGE

  • TRADENAME (Naloxone Hydrochloride) Nasal Spray

    Naloxone 10 mgNaloxone 10 mg

  • INGREDIENTS AND APPEARANCE
    NALOXONE 
    naloxone spray
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43674-003
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE10 mg  in 0.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43674-003-022 in 1 CARTON06/28/2024
    11 in 1 BLISTER PACK
    10.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21548706/28/2024
    Labeler - Summit Biosciences Inc. (832920081)
    Registrant - Summit Biosciences Inc. (832920081)
    Establishment
    NameAddressID/FEIBusiness Operations
    Summit Biosciences Inc.832920081analysis(43674-003) , label(43674-003) , manufacture(43674-003) , pack(43674-003)