Medicine
Rayaldee 30 mcg extended-release capsule
Rayaldee 30 mcg extended-release capsule is a prescription medicine containing Calcifediol for oral use, marketed by OPKO Pharmaceuticals, 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 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to…
Key facts
- Active ingredient (INN)
- Calcifediol
- Brand
- Rayaldee
- Strength
- 30 mcg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 30 capsules, 60 capsules and 1 more
- Marketing authorisation holder
- OPKO Pharmaceuticals
- Manufacturer
- OPKO Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A11CC06 Calcifediol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 October 2016
- Identifiers
- RxCUI 1855066, 1855072DailyMed set ID 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77NDC 70301-1001, 70301-1002Application NDA208010
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 capsule, extended release in 1 bottle | 70301-1001-1 | OPKO Pharmaceuticals | 25 October 2016 |
| 60 capsule, extended release in 1 bottle | 70301-1001-2 | OPKO Pharmaceuticals | 25 October 2016 |
| 30 capsule, extended release in 1 bottle | 70301-1002-1 | OPKO Pharmaceuticals | 11 March 2024 |
| 60 capsule, extended release in 1 bottle | 70301-1002-2 | OPKO Pharmaceuticals | 11 March 2024 |
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 5 August 1980 | 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
Clinical summary
Calcifediol is a vitamin D3 analog. It is available as extended-release capsules for oral use. MedsAcross supplies Calcifediol 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 CalcifediolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rayaldee prescribing information (OPKO Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Rayaldee 30 mcg extended-release 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.