Drug company (FDA labeler)

Fresenius Medical Care Renal Therapies Group, LLC

NDC labeler code: 49230

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

3Prescription medicines

7Products (NDC)

4FDA applications

0Recalls

Prescription medicines

Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextroseDelflex, Dianeal Low Calcium with Dextrose, Dianeal Pd-2 with Dextrose · 8 products
Sodium chlorideBacteriostatic Sodium Chloride · 1 product
Sucroferric oxyhydroxideVelphoro · 1 product

FDA applications for these products

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ANDA: Abbreviated New Drug Application: how a generic version is approved.

Approved	Application	Medicine	Sponsor
November 27, 2013	NDA205109	Sucroferric oxyhydroxide VELPHORO	Vifor Fresenius
April 12, 2007	ANDA078177	Sodium chloride SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	Fresenius Medcl
August 19, 1992	NDA020171	Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	Fresenius Medcl
November 30, 1984	NDA018883	Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER	Fresenius Medcl

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

No recall of these products (by NDC code) appears in the FDA enforcement reports.

Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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