Prescription medicine
Calcitriol Brand names: Vectical; first approved as Rocaltrol
Calcitriol (Rocaltrol) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.153 per calcitriol 0.25 mcg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the calcitriol FDA label on DailyMed (effective October 23, 2024, Amneal Pharmaceuticals LLC); the NDA 18044 record on Drugs@FDA; every calcitriol label on DailyMed.
Highlights of the record
FDA label of October 23, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePredialysis Patients Calcitriol capsules re 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.
Forms and strengths
Capsule; liquid-filled capsule; solution; injection; ointment.
On the market
- Earliest approval on file
- August 17, 1978 Rocaltrol, Esjay Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first October 12, 2001; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 20 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.153 per capsule Calcitriol 0.25 mcg capsule
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest June 15, 2018; 4 more by firms not listed as its makers
- FAERS reports
- 20,167 through July 30, 2026
What is calcitriol used for?
From the label: indications and usagePredialysis Patients Calcitriol capsules re 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 capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. […]
Conditions named in the indications of calcitriol's FDA labels, with every medicine labeled for each:
From other calcitriol labelsPsoriasis: Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older.
FDA pharmacologic class: Vitamin D3 Analog.
Source: FDA drug label (Calcitriol), Amneal Pharmaceuticals LLC, effective October 23, 2024 (SPL set b1fef137-63c5-4662-8cd9-b9e8b12bacb6), via openFDA; the full label on DailyMed
Is there a generic for calcitriol (Rocaltrol)?
The FDA approved the first generic calcitriol on October 12, 2001. 19 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists calcitriol from 20 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1978 earliest approval on file
- 2001 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for calcitriol (Rocaltrol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.153 per Calcitriol 0.25 mcg capsule, down 8% from $0.167 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Calcitriol 0.25 mcg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Calcitriol 0.25 mcg capsule | Generic | $0.153 per capsule | $4.60 | -8% |
| Calcitriol 0.5 mcg capsule | Generic | $0.234 per capsule | $7.02 | -0.7% |
| Calcitriol 1 mcg/mL solution | Generic | $6.60 per mL | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is calcitriol in shortage?
No calcitriol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated December 4, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Calcitriol, Capsule, .25 ug (NDC 0093-7352-01) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | December 4, 2025 |
| Calcitriol, Capsule, .5 ug (NDC 0093-7353-01) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | December 4, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has calcitriol been recalled?
The FDA's Enforcement Report lists 6 recalls naming calcitriol since 2013: 0 Class I (the most serious), 5 Class II, 1 Class III; 2 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of calcitriol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| June 15, 2018 | Class III | Validus Pharmaceuticals, Inc. | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. |
| May 1, 2014 | Class II | Boehringer Ingelheim Roxane Inc | Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the calcitriol label say about other medicines?
The calcitriol label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name calcitriol. 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 |
|---|---|---|
| Cholestyramine | drug interactions | DRUG INTERACTIONS Cholestyramine Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of calcitriol (see WARNINGS and PRECAUTIONS: |
| Ergocalciferol | warnings | If treatment is switched from ergocalciferol (vitamin D 2 ) to calcitriol, it may take several months for the ergocalciferol level in the blood to return to the baseline value (see OVERDOSAGE ). |
| Ketoconazole | drug interactions | Ketoconazole Ketoconazole may inhibit both synthetic and catabolic enzymes of calcitriol. |
| Phenobarbital | drug interactions | Phenytoin/Phenobarbital The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of calcitriol, but may reduce endogenous plasma levels of 25(OH)D 3 by accelerating metabolism. |
| Phenytoin | drug interactions | Phenytoin/Phenobarbital The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of calcitriol, but may reduce endogenous plasma levels of 25(OH)D 3 by accelerating metabolism. |
Other labels that name calcitriol
Source: FDA drug label (Calcitriol), Amneal Pharmaceuticals LLC, effective October 23, 2024 (SPL set b1fef137-63c5-4662-8cd9-b9e8b12bacb6), via openFDA; the full label on DailyMed
What do FAERS reports show for calcitriol?
The FDA Adverse Event Reporting System holds 20,167 reports that list calcitriol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,661 are coded as a death and 8,520 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
- Calcitriol side effects
- the label's list beside FAERS reports
- Calcitriol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other