Is Fresenius Medical Care Holdings, Inc. FDA approved?

Fresenius Medical Care Holdings, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Fresenius Medical Care Holdings, Inc. make?

2 products are listed under Fresenius Medical Care Holdings, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Fresenius Medical Care Holdings, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 2
Live patents: 0
Shortage listings: 7
Countries: 0

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SolutionRenal	DELFLEX, Solution, 18.4 mg/100 mL; 4.25 g/100 mL; 5.08 mg/100 mL; 538 mg/100 mL; 448 mg/100 mL (NDC 46163-212-95)	To Be Discontinued	-	10 Sept 202610 Sept 2026
Peritoneal Dialysis SolutionRenal	DELFLEX® w/Dextrose, Solution, 1.5% Low Mg/Low Ca 2L, 5/cs (NDC 46163-206-92)	To Be Discontinued	-	10 Mar 202610 Mar 2026
Peritoneal Dialysis SolutionRenal	DELFLEX® w/Dextrose, Solution, 2.5% Low Mg/Low Ca 2L, 5/cs (NDC 49230-209-92)	To Be Discontinued	-	10 Mar 202610 Mar 2026
Peritoneal Dialysis SolutionRenal	DELFLEX® w/Dextrose, Solution, 4.25% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 46163-212-94)	To Be Discontinued	-	10 Mar 202610 Mar 2026
Peritoneal Dialysis SolutionRenal	DELFLEX® w/Dextrose, Solution, 2.5% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 49230-209-94)	To Be Discontinued	-	10 Mar 202610 Mar 2026
Peritoneal Dialysis SolutionRenal	DELFLEX® w/Dextrose, Solution, 4.25% Low Mg/Low Ca 2L, 5/cs (NDC 46163-212-92)	To Be Discontinued	-	10 Mar 202610 Mar 2026
Peritoneal Dialysis SolutionRenal	DELFLEX® w/Dextrose, Solution, 1.5% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 49230-206-94)	To Be Discontinued	-	10 Mar 202610 Mar 2026

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
injection, solution	2

Route	NDCs
intravenous	2

Labeller name on the listing	NDCs
fresenius medical care holdings, inc.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Venofer	iron sucrose	injection, solution, intravenous	49230-530NDA
Venofer	iron sucrose	injection, solution, intravenous	49230-534NDA

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Other companies listing iron sucrose

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Enquiry

Common questions

Is Fresenius Medical Care Holdings, Inc. FDA approved?: Fresenius Medical Care Holdings, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Fresenius Medical Care Holdings, Inc. make?: 2 products are listed under Fresenius Medical Care Holdings, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.