Isoplate

Product NDC

14537-408

11-digit product format

145370408

Labeler code

14537

Product ID

14537-408_18d184d6-1606-4e5c-a25f-6a4acf283358

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE, MONOBASIC

Dosage form

SOLUTION

Route

INTRAVENOUS

Labeler

Terumo BCT Ltd.

Application

BN090067

Marketing category

NDA

Marketing start

2013-03-05

Marketing end

0000-00-00

Substance

SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; POTASSIUM PHOSPHATE, MONOBASIC

Active strength

1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL

Pharmacologic 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

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record