DrugDashboards

Azstarys

Serdexmethylphenidate and Dexmethylphenidate · SERDEXMETHYLPHENIDATE CHLORIDE 39.2 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 7.8 mg/1 · Capsule · Oral · Commave Sub, LLC

NDC 65038-0429-99 · 100 CAPSULE in 1 BOTTLE, PLASTIC · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $14.42 per unit over the past year. 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)$14.42per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$13.86per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$13.20per unitnegotiated price across 10 plans — before rebates · Jul 1, 2024
  • Federal ceiling (Big4)$9.67per unitCorium, LLC · Jan 1, 202667% of what pharmacies pay — a deeper discount than 76% of drugs with this benchmark

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
$13.20per unit
middle half $13.20$13.39 · 10 plans · Jul 1, 2024
Est. net of rebates
$7.92–$9.90
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 3 quarters since 2024.

NADAC price per unit

$0$5.00$10.00$15.00May 2022Sep 2026$14.42
27 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$432.65
#90 count
$1297.94

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

Medicaid spend (2025)

$28.3M
73,060 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

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

  • 1 active manufacturer+30

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 serdexmethylphenidate and dexmethylphenidate (oral solid) in the next 90 days

price up 4% YoY

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 →

Regulatory

Application
NDA212994
TE code
Approval date
May 7, 2021
Patents / exclusivity
18 patents, 3 exclusivities
TypeNumber / codeExpires
exclusivityNCEMay 7, 2026
exclusivityNCEMay 7, 2026
exclusivityNCEMay 7, 2026
patent10954213Dec 9, 2037
patent10954213Dec 9, 2037
patent10858341Dec 9, 2037
patent10584112Dec 9, 2037
patent10584112Dec 9, 2037
patent10584113Dec 9, 2037
patent10759778Dec 9, 2037
patent10759778Dec 9, 2037
patent10584113Dec 9, 2037

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Serdexmethylphenidate and Dexmethylphenidate (Capsule)

LabelerStrengthFirst seenLast seen
Commave Sub, LLCSERDEXMETHYLPHENIDATE CHLORIDE 52.3 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 10.4 mg/1Aug 26, 2026Sep 2, 2026
Commave Sub, LLCSERDEXMETHYLPHENIDATE CHLORIDE 26.1 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 5.2 mg/1Aug 26, 2026Sep 2, 2026
Commave Sub, LLCSERDEXMETHYLPHENIDATE CHLORIDE 39.2 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 7.8 mg/1Aug 26, 2026Sep 2, 2026
Commave Sub, LLCSERDEXMETHYLPHENIDATE CHLORIDE 7.8 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 39.2 mg/1Jul 22, 2026Aug 19, 2026
Commave Sub, LLCSERDEXMETHYLPHENIDATE CHLORIDE 10.4 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 52.3 mg/1Jul 22, 2026Aug 19, 2026
Commave Sub, LLCSERDEXMETHYLPHENIDATE CHLORIDE 5.2 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 26.1 mg/1Jul 22, 2026Aug 19, 2026
Commave Sub, LLCDEXMETHYLPHENIDATE HYDROCHLORIDE 10.4 mg/1; SERDEXMETHYLPHENIDATE CHLORIDE 52.3 mg/1Jul 15, 2026Jul 15, 2026
Commave Sub, LLCDEXMETHYLPHENIDATE HYDROCHLORIDE 5.2 mg/1; SERDEXMETHYLPHENIDATE CHLORIDE 26.1 mg/1Jul 15, 2026Jul 15, 2026
Commave Sub, LLCDEXMETHYLPHENIDATE HYDROCHLORIDE 7.8 mg/1; SERDEXMETHYLPHENIDATE CHLORIDE 39.2 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Azstarys — NDC 65038-0429-99," retrieved September 3, 2026, https://drugdashboards.com/drug/65038042999.

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