DrugDashboards

Vanflyta

Quizartinib · QUIZARTINIB DIHYDROCHLORIDE 17.7 mg/1 · Tablet, Film Coated · Oral · Daiichi Sankyo Inc.

NDC 65597-0504-04 · 1 BOTTLE in 1 CARTON / 14 TABLET, FILM COATED in 1 BOTTLE · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

  • Part D plans paid (avg)$533.54per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$420.32per unitDaiichi Sankyo, Inc. · Jan 1, 2026

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 65597-0504-28) — 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
$627.37per unit
middle half $606.92$652.10 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$376.42–$470.53
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 98% · step therapy 0% · qty limit 88%

*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.

Estimated fill cost

WAC per package, as filed
$8,752.36
Reported to Texas DSHS · 2026 annual filing · Daiichi Sankyo, Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Is this a "specialty" drug?

There's no legal definition — it meets 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $18,100.05 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Vanflyta

Regulatory

Application
NDA216993
TE code
Approval date
Jul 20, 2023
Patents / exclusivity
22 patents, 4 exclusivities
TypeNumber / codeExpires
exclusivityODE-437Jul 20, 2030
exclusivityODE-437Jul 20, 2030
exclusivityNCEJul 20, 2028
exclusivityNCEJul 20, 2028
patent9675549Sep 30, 2033
patent9675549Sep 30, 2033
patent8357690Feb 26, 2031
patent8357690Feb 26, 2031
patent9555040May 14, 2030
patent9555040May 14, 2030
patent8836218Mar 23, 2030
patent8836218Mar 23, 2030

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Quizartinib (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Daiichi Sankyo Inc.QUIZARTINIB DIHYDROCHLORIDE 17.7 mg/1Jul 15, 2026Sep 2, 2026
Daiichi Sankyo Inc.QUIZARTINIB DIHYDROCHLORIDE 26.5 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Vanflyta — NDC 65597-0504-04," retrieved September 3, 2026, https://drugdashboards.com/drug/65597050404.

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