FDA label
What is calcitriol used for?
The FDA-approved uses of calcitriol, 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 for calcitriol lists 3 uses: Predialysis Patients; Dialysis Patients; Hypoparathyroidism Patients.
Run it in Rivvi
Which 2027 plans near you dropped or restricted calcitriol?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Calcitriol Capsules 0.25 Mcg, capsule
Indications and Usage, quoted from the label by Strides Pharma Science Limited (ANDA091356). Cross-references to other label sections are left out.
Predialysis Patients
Calcitriol capsule is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism.
Dialysis Patients
Calcitriol capsule is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.
Hypoparathyroidism Patients
Calcitriol capsule is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
Source: DailyMed label, set id bebefb2a-7365-48e2-9681-83ed4b41e26e, version 12, effective June 23, 2026. NDC 64380-723, one of 18 listings for this product.
Questions
What is calcitriol used for?
The FDA label for calcitriol lists 3 uses: Predialysis Patients; Dialysis Patients; Hypoparathyroidism Patients.
What drug class is calcitriol?
FDA lists calcitriol 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.