Delflex

Product NDC

46163-209

11-digit product format

461630209

Labeler code

46163

Product ID

46163-209_444fd7c1-1ed5-25c7-e063-6394a90a3bfe

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Dosage form

SOLUTION

Route

INTRAPERITONEAL

Labeler

Fresenius Medical Care de Mexico, S.A. de C.V.

Application

NDA020171

Marketing category

NDA

Marketing start

2024-08-29

Substance

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

Active strength

18.4; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL

Pharmacologic classes

Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

NDC exclude flag

No

Listing certified through

2026-12-31

Current FDA listing

Yes