Medicine
Recorlev 150 mg tablet
Recorlev 150 mg tablet is a prescription medicine containing Levoketoconazole for oral use, marketed by Xeris 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 RECORLEV at 20° to 25°C (68° to 77°F), excursions permitted between 15°…
Key facts
- Active ingredient (INN)
- Levoketoconazole
- Brand
- Recorlev
- Strength
- 150 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 50 tablets
- Marketing authorisation holder
- Xeris Pharmaceuticals
- Manufacturer
- Xeris Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store RECORLEV at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 December 2021
- Identifiers
- RxCUI 2588848, 2588854DailyMed set ID d4c5fead-bc4a-fb02-e053-2a95a90ae4fcNDC 72065-003Application NDA214133
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 |
|---|---|---|---|
| 50 tablet in 1 bottle | 72065-003-01 | Xeris Pharmaceuticals | 30 December 2021 |
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 30 December 2021 | 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
Levoketoconazole is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. MedsAcross supplies Levoketoconazole 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 LevoketoconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Recorlev prescribing information (Xeris Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Recorlev 150 mg tablet 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.