NDC 14537-408

Isoplate

Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic

Isoplate is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Terumo Bct Ltd.. The primary component is Sodium Chloride; Sodium Gluconate; Sodium Acetate; Potassium Chloride; Magnesium Chloride; Sodium Phosphate, Dibasic, Unspecified Form; Potassium Phosphate, Monobasic.

• Product ID: 14537-408_18d184d6-1606-4e5c-a25f-6a4acf283358
• NDC: 14537-408
• Product Type: Human Prescription Drug
• Proprietary Name: Isoplate
• Generic Name: Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-03-05
• Marketing Category: NDA / NDA
• Application Number: BN090067
• Labeler Name: Terumo BCT Ltd.
• Substance Name: SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; POTASSIUM PHOSPHATE, MONOBASIC
• Active Ingredient Strength: 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
• Pharm Classes: 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],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 14537-408-50

18 CONTAINER in 1 CASE (14537-408-50) > 500 mL in 1 CONTAINER

• Marketing Start Date: 2013-03-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 14537-408-50 [14537040850]

Isoplate SOLUTION

• Marketing Category: NDA
• Application Number: BN090067
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-03-05

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM CHLORIDE	.53 g/100mL

OpenFDA Data

• SPL SET ID: 37932532-4fbf-4485-abe6-d2c9f9fc3b80
• Manufacturer:
  • Terumo BCT Ltd.
• UNII:
  • 4J9FJ0HL51
  • 02F3473H9O
  • 4550K0SC9B
  • R6Q3791S76
  • GR686LBA74
  • 451W47IQ8X
  • 660YQ98I10

Pharmacological Class

• 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]
• 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]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]