DrugDashboards

Temozolomide

temozolomide · TEMOZOLOMIDE 5 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.

NDC 16571-0816-51 · 5 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble. A Class II recall hit this product in the past year (Rising Pharma Holding, Inc.). One of its named manufacturing plants, Eugia Pharma Specialities Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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)$1.93per EAinvoice-surveyed acquisition cost · Aug 20, 2025
  • Part D plans paid (avg)$52.06per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$2.25per CAPweighted avg manufacturer price $1.2880 · Jul 1, 2026117% of what pharmacies pay — higher than 67% 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$1.00$2.00Jun 2025Aug 2025$1.93
3 price points · per EA · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$57.94
#90 count
$173.82

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

Medicaid spend (2025)

$175
15 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

15Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • Class I/II recall in past 12 months+15

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 temozolomide (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · 1 Class I/II recall(s) in 12 months

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 →

Regulatory

Application
ANDA206309
TE code
AB
Approval date
Apr 27, 2016
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingMar 3, 2026
    Rising Pharma Holding, Inc.Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Manufacturers of temozolomide (Capsule)

LabelerStrengthFirst seenLast seen
Accord Healthcare Inc.TEMOZOLOMIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.TEMOZOLOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.TEMOZOLOMIDE 180 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.TEMOZOLOMIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.TEMOZOLOMIDE 140 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.TEMOZOLOMIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCTEMOZOLOMIDE 140 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCTEMOZOLOMIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCTEMOZOLOMIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCTEMOZOLOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCTEMOZOLOMIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCTEMOZOLOMIDE 180 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCTEMOZOLOMIDE 180 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCTEMOZOLOMIDE 140 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCTEMOZOLOMIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCTEMOZOLOMIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCTEMOZOLOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCTEMOZOLOMIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackTEMOZOLOMIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackTEMOZOLOMIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackTEMOZOLOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackTEMOZOLOMIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackTEMOZOLOMIDE 140 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackTEMOZOLOMIDE 180 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TEMOZOLOMIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TEMOZOLOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TEMOZOLOMIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TEMOZOLOMIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TEMOZOLOMIDE 180 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TEMOZOLOMIDE 140 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCTEMOZOLOMIDE 20 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCTEMOZOLOMIDE 100 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCTEMOZOLOMIDE 5 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCTEMOZOLOMIDE 140 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCTEMOZOLOMIDE 180 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCTEMOZOLOMIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Devatis, Inc.TEMOZOLOMIDE 180 mg/1Jul 15, 2026Sep 2, 2026
Devatis, Inc.TEMOZOLOMIDE 250 mg/1Jul 15, 2026Sep 2, 2026
Devatis, Inc.TEMOZOLOMIDE 140 mg/1Jul 15, 2026Sep 2, 2026
Devatis, Inc.TEMOZOLOMIDE 5 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Temozolomide — NDC 16571-0816-51," retrieved September 3, 2026, https://drugdashboards.com/drug/16571081651.

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