FDA.reportPublic FDA data

Application 017609

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATEINJECTABLE;INJECTION5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017609-001NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017609-001NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017609-001NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017609-001NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017609-001NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 017609
application number: NDA017609
ndc (product): 0990-7968

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideHospira, Inc.NDACurrent
0409-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideHospira, Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium ChlorideICU Medical Inc.NDACurrent