DrugDashboards

rilzabrutinib

rilzabrutinib · RILZABRUTINIB 400 mg/1 · Tablet, Film Coated · Sanofi S.r.l.

NDC 12522-3331-02 · 16 KIT in 1 BOX / 2 DOSE PACK in 1 KIT / 2 BLISTER PACK in 1 DOSE PACK / 14 TABLET, FILM COATED in 1 BLISTER PACK · 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 58468-0251-06) — 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
$278.41per unit
middle half $278.41$300.99 · 19 plans · Apr 1, 2026
Est. net of rebates
≈ $278.41
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 47%

*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 2 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.

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 rilzabrutinib (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Genzyme CorporationRILZABRUTINIB 400 mg/1Jul 15, 2026Sep 2, 2026
Sanofi S.r.l.RILZABRUTINIB 400 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "rilzabrutinib — NDC 12522-3331-02," retrieved September 3, 2026, https://drugdashboards.com/drug/12522333102.

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