FDA label
What is Rayaldee used for?
Rayaldee contains calcifediol. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.”
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Rayaldee, capsule, extended release
Indications and Usage, quoted from the label by OPKO Pharmaceuticals LLC (NDA208010). Cross-references to other label sections are left out.
RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.
Limitations of Use
RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.
Source: DailyMed label, set id 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77, version 11, effective January 19, 2024. NDC 70301-1001, one of 2 listings for this product.
Questions
What is Rayaldee used for?
The FDA label says: “RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.”
What drug class is Rayaldee?
FDA lists calcifediol in the Vitamin D3 Analog established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.