DrugDashboards

imatinib mesylate

imatinib mesylate · IMATINIB MESYLATE 400 mg/1 · Tablet · Novartis Pharma Produktions GmbH

NDC 66828-0310-01 · 25000 TABLET in 1 DRUM · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00078-0649-13) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of saleⓘ
$330.52per unit
middle half $330.52–$330.52 · 2 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $330.52
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 100% · step therapy 0% · qty limit 100%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 6 quarters since 2024.

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 imatinib mesylate (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 →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $1,694.32 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
—
TE code
—
Approval date
—
Patents / exclusivity
—

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of imatinib mesylate (Tablet)

LabelerStrengthFirst seenLast seen
Archis Pharma LLCIMATINIB MESYLATE 100 mg/1Jul 15, 2026Sep 2, 2026
Archis Pharma LLCIMATINIB MESYLATE 400 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharma Produktions GmbHIMATINIB MESYLATE 400 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharma Produktions GmbHIMATINIB MESYLATE 100 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationIMATINIB MESYLATE 100 mg/1Jul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.IMATINIB MESYLATE 100 mg/1Jul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.IMATINIB MESYLATE 400 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCIMATINIB MESYLATE 400 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCIMATINIB MESYLATE 100 mg/1Jul 15, 2026Sep 2, 2026
Novartis Pharmaceuticals CorporationIMATINIB MESYLATE 400 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "imatinib mesylate — NDC 66828-0310-01," retrieved September 3, 2026, https://drugdashboards.com/drug/66828031001.

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