NDC 0409-7965

Normosol-M and Dextrose

Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate

Normosol-M and Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Dextrose Monohydrate; Sodium Chloride; Potassium Acetate; Magnesium Acetate.

Product ID0409-7965_86cb991a-eca9-4aa2-a93d-6a11e64b709d
NDC0409-7965
Product TypeHuman Prescription Drug
Proprietary NameNormosol-M and Dextrose
Generic NameDextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1975-08-13
Marketing End Date2021-05-01
Marketing CategoryNDA / NDA
Application NumberNDA017610
Labeler NameHospira, Inc.
Substance NameDEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE
Active Ingredient Strength5 g/100mL; mg/100mL; mg/100mL; mg/100mL
Pharm ClassesOsmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC Exclude FlagN

Packaging

NDC 0409-7965-09

12 POUCH in 1 CASE (0409-7965-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG
Marketing Start Date1975-08-13
Marketing End Date2021-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-7965-48 [00409796548]

Normosol-M and Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1975-08-13
Marketing End Date1975-08-14

NDC 0409-7965-03 [00409796503]

Normosol-M and Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017610
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1975-08-13

NDC 0409-7965-30 [00409796530]

Normosol-M and Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1975-08-13
Marketing End Date1975-08-14

NDC 0409-7965-09 [00409796509]

Normosol-M and Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017610
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1975-08-13

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL

OpenFDA Data

SPL SET ID:7cfe22f2-b8c8-421b-6aa0-bf73bea73a4b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 801005
  • 801009
  • Pharmacological Class

    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Potassium Compounds [CS]
    • Potassium Salt [EPC]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Calculi Dissolution Agent [EPC]
    • Magnesium Ion Exchange Activity [MoA]
    • Osmotic Laxative [EPC]
    • Osmotic Activity [MoA]
    • Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
    • Increased Large Intestinal Motility [PE]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]

    NDC Crossover Matching brand name "Normosol-M and Dextrose" or generic name "Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate"

    NDCBrand NameGeneric Name
    0409-7965Normosol-M and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE
    0990-7965NORMOSOL-M AND DEXTROSEdextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate

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