The short version
8 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
sirolimus
sirolimus · SIROLIMUS 1 mg/1 · Tablet, Film Coated · Oral · Zydus Lifesciences Limited
NDC 65841-0772-01 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for sirolimus (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA201676
- TE code
- AB
- Approval date
- Jan 8, 2014
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of sirolimus (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| American Health Packaging | SIROLIMUS .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | SIROLIMUS 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | SIROLIMUS 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | SIROLIMUS .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | SIROLIMUS 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | SIROLIMUS .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | SIROLIMUS 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | SIROLIMUS 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx Llc | SIROLIMUS 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx Llc | SIROLIMUS .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx Llc | SIROLIMUS 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | SIROLIMUS 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | SIROLIMUS 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | SIROLIMUS .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | SIROLIMUS 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | SIROLIMUS .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | SIROLIMUS 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Remedyrepack Inc. | SIROLIMUS .5 mg/1 | Jul 15, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "sirolimus — NDC 65841-0772-01," retrieved September 3, 2026, https://drugdashboards.com/drug/65841077201.
Free to cite with attribution — see how the data is put together.