Lanadelumab-flyo
Lanadelumab-flyo · LANADELUMAB 300 mg/2mL · Injection, Solution · Rentschler Biopharma SE
NDC 64538-0644-00 · 5 mL in 1 VIAL, GLASS · BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (bulk ingredient for human prescription compounding) 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 47783-0644-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
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.
*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 10 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.
Is this a "specialty" drug?
There's no legal definition — it meets 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $46,928.64 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 Lanadelumab-flyo (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Rentschler Biopharma SE | LANADELUMAB 300 mg/2mL | Jul 15, 2026 | Sep 2, 2026 |
| Takeda Pharmaceuticals America, Inc. | LANADELUMAB 300 mg/2mL | Jul 15, 2026 | Aug 26, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Lanadelumab-flyo — NDC 64538-0644-00," retrieved September 3, 2026, https://drugdashboards.com/drug/64538064400.
Free to cite with attribution — see how the data is put together.