NDC 0264-7730

Isolyte P in Dextrose

Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, And Potassium Phosphate, Dibasic

Isolyte P in Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Dextrose Monohydrate; Sodium Acetate; Potassium Chloride; Magnesium Chloride; Potassium Phosphate, Dibasic.

Product ID0264-7730_451ceb0a-c083-4f3d-9c6e-87f10513211c
NDC0264-7730
Product TypeHuman Prescription Drug
Proprietary NameIsolyte P in Dextrose
Generic NameDextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, And Potassium Phosphate, Dibasic
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1993-06-10
Marketing CategoryNDA / NDA
Application NumberNDA019873
Labeler NameB. Braun Medical Inc.
Substance NameDEXTROSE MONOHYDRATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC
Active Ingredient Strength5 g/100mL; g/100mL; g/100mL; g/100mL; g/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],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0264-7730-10

24 CONTAINER in 1 CASE (0264-7730-10) > 500 mL in 1 CONTAINER
Marketing Start Date1993-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0264-7730-10 [00264773010]

Isolyte P in Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019873
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1993-06-10

NDC 0264-7730-20 [00264773020]

Isolyte P in Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019873
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1993-06-10
Marketing End Date2011-02-28

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL

OpenFDA Data

SPL SET ID:4ea4397c-2fa4-4670-91e6-21ae498c88f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 800808
  • 800812
  • 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]
    • Potassium Compounds [CS]
    • Potassium Salt [EPC]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]

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