Label: KYNAMRO- mipomersen sodium injection, solution

  • NDC Code(s): 70688-0502-1, 70688-0502-2
  • Packager: Kastle Therapeutics, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated January 17, 2017

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  • SPL UNCLASSIFIED SECTION

    KYNAMRO- MIPOMERSEN SODIUM INJECTION, SOLUTION

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    KYNAMRO 
    mipomersen sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70688-0502
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MIPOMERSEN SODIUM (UNII: 18EAY4870E) (MIPOMERSEN - UNII:9GJ8S4GU0M) MIPOMERSEN SODIUM200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70688-0502-11 in 1 CARTON05/02/2016
    11 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:70688-0502-24 in 1 CARTON05/02/2016
    21 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20356805/02/2016
    Labeler - Kastle Therapeutics, LLC (080134022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genzyme Corporation098066215MANUFACTURE(70688-0502) , ANALYSIS(70688-0502) , PACK(70688-0502) , LABEL(70688-0502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genzyme Haverhill229522842PACK(70688-0502) , ANALYSIS(70688-0502) , LABEL(70688-0502)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Laboratory Services, Ltd777381963STERILIZE(70688-0502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ionis Pharmaceuticals Inc.011829916API MANUFACTURE(70688-0502) , ANALYSIS(70688-0502)
    Establishment
    NameAddressID/FEIBusiness Operations
    PCI Pharma Services053217022LABEL(70688-0502) , PACK(70688-0502)