Prescription medicine
Calcifediol Brand names: Rayaldee; first approved as Calderol
Calcifediol (Rayaldee) is a prescription medicine with an FDA approval on record since 1980. No generic is listed; pharmacies paid $41.26 per capsule (Rayaldee ER 30 mcg capsule (hard)) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the calcifediol FDA label on DailyMed (effective January 19, 2024, OPKO Pharmaceuticals LLC); the NDA 18312 record on Drugs@FDA; every calcifediol label on DailyMed.
Highlights of the record
FDA label of January 19, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRAYALDEE is a vitamin D 3 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.
Forms and strengths
Extended-release capsule.
On the market
- Earliest approval on file
- August 5, 1980 Calderol, Organon Usa Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 14, 2034 Rayaldee capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $41.26 per capsule Rayaldee ER 30 mcg capsule (hard)
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,421 through July 30, 2026
What is calcifediol used for?
From the label: indications and usageRAYALDEE is a vitamin D 3 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. RAYALDEE is a vitamin D 3 analog indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. […]
FDA pharmacologic class: Vitamin D3 Analog.
Source: FDA drug label (Rayaldee), NDA208010 (Eirgen), as published by OPKO Pharmaceuticals LLC, effective January 19, 2024 (SPL set 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77), via openFDA; the full label on DailyMed
Is there a generic for calcifediol (Rayaldee)?
No generic calcifediol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 16 patents for Rayaldee capsules, the last expiring on March 14, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1980 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for calcifediol (Rayaldee)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $41.26 per capsule (Rayaldee ER 30 mcg capsule (hard)), up 3% from $40.03 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Rayaldee ER 30 mcg capsule (hard) (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rayaldee ER 30 mcg capsule (hard) | Brand | $41.26 per capsule | $1,237.79 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the calcifediol label say about other medicines?
The calcifediol label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name calcifediol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | CYP3A Inhibitors Cytochrome P450 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole, may inhibit enzymes involved in vitamin D metabolism (CYP24A1 and CYP27B1), and may alter serum levels of calcifediol. |
| Cholestyramine | drug interactions | Cholestyramine may impair the absorption of calcifediol. |
| Clarithromycin | drug interactions | CYP3A Inhibitors Cytochrome P450 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole, may inhibit enzymes involved in vitamin D metabolism (CYP24A1 and CYP27B1), and may alter serum levels of calcifediol. |
| Itraconazole | drug interactions | CYP3A Inhibitors Cytochrome P450 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole, may inhibit enzymes involved in vitamin D metabolism (CYP24A1 and CYP27B1), and may alter serum levels of calcifediol. |
| Ketoconazole | drug interactions | Co-administration of cytochrome P450 inhibitors, such as ketoconazole, may alter serum levels of calcifediol. |
| Nefazodone | drug interactions | CYP3A Inhibitors Cytochrome P450 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole, may inhibit enzymes involved in vitamin D metabolism (CYP24A1 and CYP27B1), and may alter serum levels of calcifediol. |
| Nelfinavir | drug interactions | CYP3A Inhibitors Cytochrome P450 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole, may inhibit enzymes involved in vitamin D metabolism (CYP24A1 and CYP27B1), and may alter serum levels of calcifediol. |
| Phenobarbital | drug interactions | The half-life of calcifediol is reduced by drugs stimulating microsomal hydroxylation, such as phenobarbital or other anticonvulsants. |
| Ritonavir | drug interactions | CYP3A Inhibitors Cytochrome P450 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole, may inhibit enzymes involved in vitamin D metabolism (CYP24A1 and CYP27B1), and may alter serum levels of calcifediol. |
| Voriconazole | drug interactions | CYP3A Inhibitors Cytochrome P450 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole, may inhibit enzymes involved in vitamin D metabolism (CYP24A1 and CYP27B1), and may alter serum levels of calcifediol. |
Other labels that name calcifediol
Source: FDA drug label (Rayaldee), NDA208010 (Eirgen), as published by OPKO Pharmaceuticals LLC, effective January 19, 2024 (SPL set 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77), via openFDA; the full label on DailyMed
What do FAERS reports show for calcifediol?
The FDA Adverse Event Reporting System holds 2,421 reports that list calcifediol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 356 are coded as a death and 1,228 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other vitamin d3 analogs
- the pharmacologic class, with prices and generics
- Calcifediol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other