Medicine
Sirolimus 0.5 mg tablet
Sirolimus 0.5 mg tablet is a generic prescription medicine for oral use, made by 8 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
Sirolimus Tablets should be stored at 20°C to 25°C [USP Controlled Room…
Key facts
- Active ingredient (INN)
- Sirolimus
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 21 more
- Manufacturers
- Zydus LifesciencesIndiaAscend LaboratoriesIndiaGlenmark PharmaceuticalsIndiaRemedyrepackAmerican Health PackagingAvPAKMylan PharmaceuticalsNorthStar Rx
- Origin register
- US FDA, United States
- Storage
- Sirolimus Tablets should be stored at 20°C to 25°C [USP Controlled Room Temperature] (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AH01 Sirolimus
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 January 2014
- Identifiers
- RxCUI 349208, 360110, 905158DailyMed set ID 5908cd1a-fc5a-462f-99ed-1d8983e253c9, ad39eb60-1fa0-4722-8ba1-523194921c2a, cdc49844-3e77-41d3-8287-b16d0c4742c5 +8NDC 59762-1001, 16714-187, 67877-746 +8Application NDA021110, ANDA208691, ANDA214753 +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 |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65841-771-01 | Zydus LifesciencesIndia | 15 January 2014 |
| 500 tablet, film coated in 1 bottle | 65841-771-05 | Zydus LifesciencesIndia | 15 January 2014 |
| 30 tablet, film coated in 1 bottle | 65841-771-06 | Zydus LifesciencesIndia | 15 January 2014 |
| 1000 tablet, film coated in 1 bottle | 65841-771-10 | Zydus LifesciencesIndia | 15 January 2014 |
| 90 tablet, film coated in 1 bottle | 65841-771-16 | Zydus LifesciencesIndia | 15 January 2014 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65841-771-77 | Zydus LifesciencesIndia | 15 January 2014 |
| 100 tablet, film coated in 1 bottle | 68382-520-01 | Zydus LifesciencesIndia | 15 January 2014 |
| 500 tablet, film coated in 1 bottle | 68382-520-05 | Zydus LifesciencesIndia | 15 January 2014 |
| 30 tablet, film coated in 1 bottle | 68382-520-06 | Zydus LifesciencesIndia | 15 January 2014 |
| 1000 tablet, film coated in 1 bottle | 68382-520-10 | Zydus LifesciencesIndia | 15 January 2014 |
| 90 tablet, film coated in 1 bottle | 68382-520-16 | Zydus LifesciencesIndia | 15 January 2014 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 68382-520-77 | Zydus LifesciencesIndia | 15 January 2014 |
| 100 tablet, film coated in 1 bottle | 67877-746-01 | Ascend LaboratoriesIndia | 13 March 2021 |
| 500 tablet, film coated in 1 bottle | 67877-746-05 | Ascend LaboratoriesIndia | 13 March 2021 |
| 30 tablet, film coated in 1 bottle | 67877-746-30 | Ascend LaboratoriesIndia | 13 March 2021 |
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-746-38 | Ascend LaboratoriesIndia | 13 March 2021 |
| 100 tablet, film coated in 1 bottle | 68462-682-01 | Glenmark PharmaceuticalsIndia | 16 October 2020 |
| 100 tablet, sugar coated in 1 bottle | 59762-1001-1 | Mylan Pharmaceuticals | 7 January 2014 |
| 100 pouch in 1 box / 1 tablet in 1 pouch | 70518-3546-0 | Remedyrepack | 30 September 2022 |
| 100 pouch in 1 box / 1 tablet, film coated in 1 pouch | 70518-4376-0 | Remedyrepack | 28 June 2025 |
| 100 pouch in 1 box / 1 tablet, film coated in 1 pouch | 70518-4449-0 | Remedyrepack | 19 August 2025 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 60687-902-21 | American Health Packaging | 2 June 2026 |
| 30 blister pack in 1 box / 1 tablet, film coated in 1 blister pack | 50268-827-13 | AvPAK | 27 October 2026 |
| 100 tablet, film coated in 1 bottle | 16714-187-01 | Northstar RX | 18 October 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.
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 Sirolimus
Clinical summary
Sirolimus is a kinase inhibitor indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants, among other approved uses. MedsAcross supplies Sirolimus 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 SirolimusFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sirolimus prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Hyftor: European public assessment report (EPAR) · European Medicines Agency
- Rapamune: European public assessment report (EPAR) · European Medicines Agency
Need Sirolimus 0.5 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.