Medicine
Calcitriol 0.5 mcg capsule
Calcitriol 0.5 mcg capsule is a generic prescription medicine for oral use, made by 11 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 15° to 30°C (59° to 86°F) Dispense in a tight, light-resistant…
Key facts
- Active ingredient (INN)
- Calcitriol
- Brand
- Sold under the generic name
- Strength
- 0.5 mcg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 1000 capsules, 30 capsules and 21 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAvet PharmaceuticalsIndiaStrides PharmaIndiaBryant Ranch PrepackAmneal PharmaceuticalsBionpharmaChartwell RXEpic PharmaGolden State Medical SupplyRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store at 15° to 30°C (59° to 86°F) Dispense in a tight, light-resistant container as defined in USP.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A11CC04 Calcitriol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 May 2013
- Identifiers
- RxCUI 308867, 308868DailyMed set ID 554a54a0-3e46-4a9d-8e54-3d853302dbbb, 6c68beb7-1fed-4652-b4e1-672fde0b621d, bebefb2a-7365-48e2-9681-83ed4b41e26e +10NDC 42806-733, 63629-8742, 64380-724 +10Application ANDA219796, ANDA075765, ANDA091356 +3
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 bottle | 23155-663-01 | Avet PharmaceuticalsIndia | 29 May 2018 |
| 100 capsule in 1 container | 64380-724-06 | Strides PharmaIndia | 27 December 2016 |
| 1000 capsule, liquid filled in 1 bottle | 62756-968-18 | Sun Pharmaceutical IndustriesIndia | 1 May 2020 |
| 30 capsule, liquid filled in 1 bottle | 62756-968-83 | Sun Pharmaceutical IndustriesIndia | 1 May 2020 |
| 100 capsule, liquid filled in 1 bottle | 62756-968-88 | Sun Pharmaceutical IndustriesIndia | 1 May 2020 |
| 30 capsule in 1 bottle | 65162-576-03 | Amneal Pharmaceuticals | 18 June 2017 |
| 100 capsule in 1 bottle | 65162-576-10 | Amneal Pharmaceuticals | 18 June 2017 |
| 250 capsule in 1 bottle | 65162-576-25 | Amneal Pharmaceuticals | 18 June 2017 |
| 30 capsule, liquid filled in 1 bottle, plastic | 69452-208-13 | Bionpharma | 12 June 2018 |
| 100 capsule, liquid filled in 1 bottle, plastic | 69452-208-20 | Bionpharma | 12 June 2018 |
| 90 capsule in 1 bottle | 62135-611-90 | Chartwell RX | 5 June 2023 |
| 100 capsule in 1 bottle | 42806-733-01 | Epic Pharma | 27 February 2026 |
| 100 capsule, liquid filled in 1 bottle | 0093-7353-01 | Teva Pharmaceuticals | 1 July 2016 |
| 100 capsule, liquid filled in 1 bottle | 63629-8742-1 | Bryant Ranch Prepack | 20 August 2021 |
| 30 capsule, liquid filled in 1 bottle | 71335-1594-1 | Bryant Ranch Prepack | 11 May 2020 |
| 8 capsule, liquid filled in 1 bottle | 71335-1594-2 | Bryant Ranch Prepack | 11 May 2020 |
| 28 capsule, liquid filled in 1 bottle | 71335-1594-3 | Bryant Ranch Prepack | 11 May 2020 |
| 90 capsule, liquid filled in 1 bottle | 71335-1594-4 | Bryant Ranch Prepack | 11 May 2020 |
| 30 capsule, liquid filled in 1 bottle, plastic | 71335-1782-1 | Bryant Ranch Prepack | 27 August 2021 |
| 8 capsule, liquid filled in 1 bottle, plastic | 71335-1782-2 | Bryant Ranch Prepack | 27 August 2021 |
| 28 capsule, liquid filled in 1 bottle, plastic | 71335-1782-3 | Bryant Ranch Prepack | 27 August 2021 |
| 90 capsule, liquid filled in 1 bottle, plastic | 71335-1782-4 | Bryant Ranch Prepack | 27 August 2021 |
| 100 capsule, liquid filled in 1 bottle, plastic | 51407-170-01 | Golden State Medical Supply | 3 January 2019 |
| 90 capsule, liquid filled in 1 bottle, plastic | 70518-4775-0 | Remedyrepack | 15 October 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 August 1978 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Calcitriol
Clinical summary
Calcitriol is a vitamin D3 analog 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. MedsAcross supplies Calcitriol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about CalcitriolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Calcitriol prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Calcitriol 0.5 mcg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.