Active ingredient
Sirolimus
39 finished FDA listings contain Sirolimus as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SIROLIMUS
- Dosage forms
- Gel, Injection, Powder, Lyophilized, For Suspension, Solution, Tablet, Tablet, Film Coated, Tablet, Sugar Coated
- Routes
- Intravenous, Oral, Topical
- Manufacturers / labelers
- 21
- Strengths listed
- .5 mg/1 · 1 mg/1 · 1 mg/ml · 2 mg/1 · 2 mg/g · 5 mg/ml
- Brand names in FDA listings
- Fyarro, Hyftor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 35302
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021083 | PF PRISM CV | 1999-09-15 | 1 |
| NDA 021110 | PF PRISM CV | 2000-08-25 | 3 |
| ANDA 201676 | ZYDUS PHARMS | 2014-01-08 | 8 |
| ANDA 201578 | DR REDDYS | 2014-10-27 | 5 |
| ANDA 211040 | NOVITIUM PHARMA | 2019-01-28 | 1 |
| ANDA 211212 | AMNEAL | 2019-10-18 | 1 |
| ANDA 211406 | APOTEX | 2019-10-22 | 1 |
| ANDA 208691 | GLENMARK PHARMS LTD | 2020-10-16 | 7 |
| ANDA 214753 | ALKEM LABS LTD | 2021-03-12 | 5 |
| NDA 213312 | AADI | 2021-11-22 | 1 |
| NDA 213478 | NOBELPHARMA | 2022-03-22 | 1 |
| ANDA 216728 | MSN | 2023-01-19 | 3 |
| ANDA 215080 | HETERO LABS LTD V | 2024-09-16 | 1 |
| ANDA 215116 | RISING | 2025-07-15 | 1 |
Official labeling on DailyMed
- SIROLIMUS TABLET [REMEDYREPACK INC.] · version 4 · 2026-07-22
- SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 1 · 2026-06-05
- SIROLIMUS TABLET, FILM COATED [NORTHSTAR RX LLC] · version 4 · 2026-05-13
- SIROLIMUS SOLUTION [BRYANT RANCH PREPACK] · version 100 · 2026-05-11
- SIROLIMUS TABLET, SUGAR COATED [MYLAN PHARMACEUTICALS INC.] · version 22 · 2026-03-26
- SIROLIMUS TABLET [AVPAK] · version 21 · 2026-03-12
- SIROLIMUS TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] · version 4 · 2026-01-29
- SIROLIMUS SOLUTION [VISTAPHARM, LLC] · version 11 · 2026-01-14
- SIROLIMUS TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 4 · 2025-11-19
- SIROLIMUS SOLUTION [RISING PHARMA HOLDINGS, INC.] · version 5 · 2025-11-17
- SIROLIMUS TABLET, FILM COATED [ASCEND LABORATORIES, LLC] · version 8 · 2025-11-17
- SIROLIMUS SOLUTION [NORTHSTAR RX LLC] · version 1 · 2025-09-01
Showing the 12 most recent of 22 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.