DrugDashboards

Zileuton

Zileuton · ZILEUTON 600 mg/1 · Tablet, Film Coated, Extended Release · Oral · Camber Pharmaceuticals, Inc.

NDC 31722-0044-12 · 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. The price is down 28% over the past year, to $2.07 per unit. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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.

  • Pharmacies pay (NADAC)$2.07per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$16.49per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$2.93per TABweighted avg manufacturer price $1.6726 · Aug 1, 2026142% of what pharmacies pay — higher than 76% of drugs with this benchmark

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$5.00$10.00$15.00Jun 2023Sep 2026$2.07
30 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$61.97
#90 count
$185.90

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$653,674
1,473 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

28Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 2 active manufacturers+20
  • price down 22% year over year+8

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for zileuton (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 $2,406.61 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA215742
TE code
AB
Approval date
Oct 11, 2022
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Zileuton (Tablet, Film Coated, Extended Release)

LabelerStrengthFirst seenLast seen
Camber Pharmaceuticals, Inc.ZILEUTON 600 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCZILEUTON 600 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Zileuton — NDC 31722-0044-12," retrieved September 3, 2026, https://drugdashboards.com/drug/31722004412.

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