DELFLEX

Product NDC

49230-203

11-digit product format

492300203

Labeler code

49230

Product ID

49230-203_f851a3d0-add7-11e2-9e96-0800200c9a66

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate

Dosage form

SOLUTION

Route

INTRAPERITONEAL

Labeler

Fresenius Medical Care North America

Application

NDA018883

Marketing category

NDA

Marketing start

1984-11-30

Marketing end

0000-00-00

Substance

DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE

Active strength

4 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL

Pharmacologic classes

Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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 flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record