DrugDashboards

Sirolimus

Sirolimus · SIROLIMUS .5 mg/1 · Tablet · Oral · Remedyrepack Inc.

NDC 70518-3546-00 · 100 POUCH in 1 BOX / 1 TABLET in 1 POUCH · ANDA · View full market →

The short version

4 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.

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 →

Regulatory

Application
ANDA214753
TE code
AB
Approval date
Mar 12, 2021
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)

LabelerStrengthFirst seenLast seen
American Health PackagingSIROLIMUS 1 mg/1Jul 15, 2026Sep 2, 2026
AvPAKSIROLIMUS 1 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedSIROLIMUS 1 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedSIROLIMUS 2 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.SIROLIMUS .5 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.SIROLIMUS 1 mg/1Jul 22, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Sirolimus — NDC 70518-3546-00," retrieved September 3, 2026, https://drugdashboards.com/drug/70518354600.

Free to cite with attribution — see how the data is put together.