- SPL INDEXING DATA ELEMENTS SECTION
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INGREDIENTS AND APPEARANCE
Application Product Concept kit Product Information Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) 3bb2a06a-64e7-1380-e8d7-189718b04a63 Quantity of Parts Part # Package Quantity Total 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 Name Basis of Strength Strength SODIUM NITRITE (UNII: M0KG633D4F) (NITRITE ION - UNII:J39976L608) SODIUM NITRITE 30 mg in 1 mL Part 2 of 2 injection Product Information Item Code (Source) 06879002-6dea-3c2f-71c1-614568bd0e06 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM THIOSULFATE (UNII: HX1032V43M) (THIOSULFATE ION - UNII:LLT6XV39PY) SODIUM THIOSULFATE 250 mg in 1 mL Application Product Concept Product Information Product Type INDEXING - PRODUCT CONCEPT Item Code (Source) d106808e-3051-96a1-aaa3-e4504dd8b3d6 Marketing Information Marketing Category Application Number or Monograph Citation NDA NDA201444 Labeler - Food and Drug Administration (927645523)