Active ingredient
Calcitriol
41 finished FDA listings contain Calcitriol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CALCITRIOL
- Dosage forms
- Capsule, Capsule, Liquid Filled, Injection, Ointment, Solution
- Routes
- Intravenous, Oral, Topical
- Manufacturers / labelers
- 23
- Strengths listed
- .25 ug/1 · .5 ug/1 · 1 ug/ml · 3 ug/g
- Brand names in FDA listings
- Calcitriol, Vectical
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1894
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021068 | ESJAY PHARMA | 1998-11-20 | 1 |
| ANDA 075765 | TEVA | 2001-10-12 | 6 |
| ANDA 076242 | HIKMA | 2003-07-18 | 1 |
| ANDA 076917 | HIKMA | 2006-03-27 | 3 |
| NDA 022087 | GALDERMA LABS LP | 2009-01-23 | 2 |
| ANDA 091174 | BIONPHARMA | 2013-05-24 | 7 |
| ANDA 091356 | ONESOURCE SPECIALTY | 2014-12-12 | 11 |
| ANDA 203289 | AMNEAL PHARMS | 2017-06-14 | 2 |
| ANDA 209798 | RISING | 2018-11-21 | 1 |
| ANDA 204556 | SUN PHARM | 2019-02-21 | 2 |
| ANDA 211030 | GLAND | 2020-02-03 | 2 |
| ANDA 203973 | ANDA REPOSITORY | 2023-07-28 | 1 |
| ANDA 219796 | HUMANWELL PURACAP | 2026-02-27 | 2 |
Official labeling on DailyMed
- CALCITRIOL CAPSULE, LIQUID FILLED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 8 · 2026-07-24
- CALCITRIOL CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] · version 104 · 2026-07-16
- CALCITRIOL SOLUTION [ANI PHARMACEUTICALS, INC.] · version 2 · 2026-07-15
- CALCITRIOL CAPSULE [HIKMA PHARMACEUTICALS USA INC.] · version 17 · 2026-07-13
- CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES PHARMA SCIENCE LIMITED] · version 12 · 2026-06-24
- CALCITRIOL CAPSULE, LIQUID FILLED [BIONPHARMA INC.] · version 5 · 2026-06-24
- CALCITRIOL CAPSULE [EPIC PHARMA LLC] · version 3 · 2026-05-14
- CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE [CARDINAL HEALTH 107, LLC] · version 7 · 2026-04-23
- CALCITRIOL CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.] · version 8 · 2026-03-10
- CALCITRIOL CAPSULE [CHARTWELL RX, LLC] · version 3 · 2025-12-10
- CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE [AMERICAN HEALTH PACKAGING] · version 5 · 2025-11-17
- CALCITRIOL CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] · version 100 · 2025-05-14
Showing the 12 most recent of 31 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.