DrugDashboards

Tolsura

Itraconazole · ITRACONAZOLE 65 mg/1 · Capsule, Gelatin Coated · Oral · Mayne Pharma Commercial LLC

NDC 51862-0462-60 · 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately.

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)$37.49per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$37.57per unitnegotiated price across 13 plans — before rebates · Jul 1, 2025
  • Federal contracts pay (FSS)$21.52per unitMayne Pharma Commercial LLC · Jan 1, 2026

Medicare Part D

All Part D pricing →
ⓘ 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
$37.57per unit
middle half $37.57$37.68 · 13 plans · Jul 1, 2025
Est. net of rebates
$22.54–$28.18
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
of plans cover it

*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 7 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
$2,363.02
Reported to Texas DSHS · 2026 annual filing · Mayne Pharma Commercial LLC

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

Medicaid spend (2025)

$72,325
30 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 itraconazole (oral solid) in the next 90 days

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 →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

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 $2,868.29 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA208901
TE code
Approval date
Dec 11, 2018
Patents / exclusivity
5 patents, 0 exclusivities
TypeNumber / codeExpires
patent10463740Jun 21, 2033
patent9713642Jun 21, 2033
patent10806792Jun 21, 2033
patent8921374Jun 21, 2033
patent9272046Jun 21, 2033

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Itraconazole (Capsule, Gelatin Coated)

LabelerStrengthFirst seenLast seen
Mayne Pharma Commercial LLCITRACONAZOLE 65 mg/1Jul 15, 2026Sep 2, 2026
Mayne Pharma International Pty LtdITRACONAZOLE 65 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Tolsura — NDC 51862-0462-60," retrieved September 3, 2026, https://drugdashboards.com/drug/51862046260.

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