Medicine
Calcitriol 1 mcg/mL oral solution
Calcitriol 1 mcg/mL oral solution is a generic prescription medicine for oral use, made by 4 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 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Calcitriol
- Brand
- Sold under the generic name
- Strength
- 1 mcg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle and 1 more
- Manufacturers
- ANI PharmaceuticalsHikma PharmaceuticalsPatrin PharmaRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°F). PROTECT FROM LIGHT.
- 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
- 18 July 2003
- Identifiers
- RxCUI 313932DailyMed set ID 3289b482-8733-484d-b1db-d7f4cdcd1ac2, c5c37779-0c26-438f-b1ca-61cf9915d233, 1bd717a4-5fdf-4697-a6b2-9df55c6517bb +1NDC 0054-3120, 39328-042, 64980-447 +1Application ANDA076242, ANDA203973, ANDA209798 +1
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 |
|---|---|---|---|
| 1 bottle, glass in 1 carton / 15 mL in 1 bottle, glass | 70954-831-10 | ANI Pharmaceuticals | 13 May 2026 |
| 1 bottle, glass in 1 carton / 15 mL in 1 bottle, glass | 0054-3120-41 | Hikma Pharmaceuticals | 18 July 2003 |
| 1 bottle, glass in 1 carton / 15 mL in 1 bottle, glass | 39328-042-15 | Patrin Pharma | 14 August 2023 |
| 1 bottle, glass in 1 carton / 15 mL in 1 bottle, glass | 64980-447-15 | Rising Pharma Holdings | 4 January 2019 |
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 1 mcg/mL oral solution 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.