Label: SPRAVATO- esketamine spray

  • NDC Code(s): 49396-0280-2, 49396-0280-3
  • Packager: Renaissance Lakewood LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: Export only

Drug Label Information

Updated December 20, 2019

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  • Renaissance label

    Shipper Label

  • INGREDIENTS AND APPEARANCE
    SPRAVATO 
    esketamine spray
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49396-0280
    Route of AdministrationNASALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESKETAMINE (UNII: 50LFG02TXD) (ESKETAMINE - UNII:50LFG02TXD) ESKETAMINE28 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49396-0280-22 in 1 CARTON12/18/2019
    11 in 1 BLISTER PACK
    11 in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:49396-0280-33 in 1 CARTON12/18/2019
    21 in 1 BLISTER PACK
    21 in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/18/2019
    Labeler - Renaissance Lakewood LLC (077744035)
    Registrant - Renaissance Lakewood LLC (077744035)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renaissance Lakewood LLC077744035manufacture(49396-0280) , analysis(49396-0280)