Label: kit

  • Category: INDEXING - PRODUCT CONCEPT

Drug Label Information

Updated December 11, 2017

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  • SPL INDEXING DATA ELEMENTS SECTION

  • INGREDIENTS AND APPEARANCE
    Application Product Concept
      kit
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)3bb2a06a-64e7-1380-e8d7-189718b04a63
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 10 mL
    Part 2 50 mL
    Part 1 of 2
      injection
    Product Information
    Item Code (Source)be4be4ef-3629-2cac-c011-02ea955a7950
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM NITRITE (UNII: M0KG633D4F) (NITRITE ION - UNII:J39976L608) SODIUM NITRITE30 mg  in 1 mL
    Part 2 of 2
      injection
    Product Information
    Item Code (Source)06879002-6dea-3c2f-71c1-614568bd0e06
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM THIOSULFATE (UNII: HX1032V43M) (THIOSULFATE ION - UNII:LLT6XV39PY) SODIUM THIOSULFATE250 mg  in 1 mL
    Application Product Concept
    Product Information
    Product TypeINDEXING - PRODUCT CONCEPTItem Code (Source)d106808e-3051-96a1-aaa3-e4504dd8b3d6
    Marketing Information
    Marketing CategoryApplication Number or Monograph Citation
    NDANDA201444
    Labeler - Food and Drug Administration (927645523)