Prescription medicine
Doxercalciferol First approved as Hectorol
Doxercalciferol (Hectorol) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the doxercalciferol FDA label on DailyMed (effective October 23, 2025, Eugia US LLC); the NDA 20862 record on Drugs@FDA; every doxercalciferol label on DailyMed.
Highlights of the record
FDA label of October 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDoxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis.
Forms and strengths
- 2ml
Capsule; injection (solution); injection.
On the market
- Earliest approval on file
- June 9, 1999 Hectorol, Sanofi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first September 23, 2011; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 8 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest April 4, 2017
- FAERS reports
- 167 through July 30, 2026
What is doxercalciferol used for?
From the label: indications and usageDoxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. Doxercalciferol is a synthetic vitamin D 2 analog: Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis.
FDA pharmacologic class: Vitamin D2 Analog.
Source: FDA drug label (Doxercalciferol), Eugia US LLC, effective October 23, 2025 (SPL set 3376536b-043d-478a-b129-7ce11ec94e3e), via openFDA; the full label on DailyMed
Is there a generic for doxercalciferol (Hectorol)?
The FDA approved the first generic doxercalciferol on September 23, 2011. 15 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists doxercalciferol from 8 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is doxercalciferol in shortage?
No doxercalciferol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated December 10, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Hectorol, Injection, 2 mcg/mL injection 50 single-dose vials (NDC 58468-0126-1) | Sanofi-Aventis U.S. LLC | To Be Discontinued | December 10, 2025 |
| Hectorol, Injection, 4 mcg/2 mL injection 50 multiple-dose vials (NDC 58468-0127-1) | Sanofi-Aventis U.S. LLC | To Be Discontinued | December 10, 2025 |
| Hectorol, Injection, 4 mcg/2 mL injection 50 single-dose vials (NDC 58468-0123-1) | Sanofi-Aventis U.S. LLC | To Be Discontinued | December 10, 2025 |
Every doxercalciferol presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has doxercalciferol been recalled?
The FDA's Enforcement Report lists 1 recall naming doxercalciferol since 2017: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 4, 2017 | Class III | West-Ward Columbus, Inc. | Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the doxercalciferol label say about other medicines?
The doxercalciferol label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name doxercalciferol. 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 |
|---|---|---|
| Erythromycin | drug interactions | … formation of active doxercalciferol moiety [see Clinical Pharmacology (12.3) ]. Examples Ketoconazole and erythromycin Intervention If a patient initiates or discontinues therapy with a cytochrome P450 inhibitor, dose adjustment of doxercalciferol may be necessary. … |
| Ketoconazole | drug interactions | … and thus reduce the formation of active doxercalciferol moiety [see Clinical Pharmacology (12.3) ]. Examples Ketoconazole and erythromycin Intervention If a patient initiates or discontinues therapy with a cytochrome P450 inhibitor, dose adjustment of doxercalciferol may be necessary. … |
| Phenobarbital | drug interactions | Enzyme Inducers Clinical Impact Doxercalciferol is activated by CYP 27 in the liver. Enzyme inducers may affect the 25-hydroxylation of doxercalciferol [see Clinical Pharmacology (12.3) ]. Examples Glutethimide and phenobarbital Intervention If a patient initiates or discontinues therapy with an enzyme inducer, dose … |
Other labels that name doxercalciferol
Source: FDA drug label (Doxercalciferol), Eugia US LLC, effective October 23, 2025 (SPL set 3376536b-043d-478a-b129-7ce11ec94e3e), via openFDA; the full label on DailyMed
What do FAERS reports show for doxercalciferol?
The FDA Adverse Event Reporting System holds 167 reports that list doxercalciferol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 56 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other vitamin d2 analogs
- the pharmacologic class, with prices and generics
- Doxercalciferol side effects
- the label's list beside FAERS reports
- Doxercalciferol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other