Labeler · US market

Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care Renal Therapies Group, LLC is a US drug labeler with US FDA registrations covering 3 drug concepts (3 currently active) across 26 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes49230

Active drugs3

Registrations5 active / 5

Packages26

Sole supplier of1 drugs

Portfolio3 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride solution	rx	3	24	SUPPLYING
Sodium Chloride injection	rx	1	1	SUPPLYING
Sucroferric Oxyhydroxide tablet, chewable	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Sucroferric Oxyhydroxiderx

At a glance

TypeLabeler
Labeler codes49230
Filing names1
Drugs (active)3
Drugs (all time)3
US registrations5
Packages26

Recent events

Shortages, recalls, and registration changes across all filing names.

Dec 20, 2017
RECALLRecall (Class II): DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2…
Nov 13, 2017
RECALLRecall (Class II): 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.