DrugDashboards

Cladribine

Cladribine · CLADRIBINE 1 mg/mL · Injection · Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0140-10 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · ANDA · 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.

  • Medicare Part B pays (ASP+6%)$8.19per billing unit (1 MG)HCPCS J9065 · Jul 1, 2026
  • Part D plans paid (avg)$37.86per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$285.73per package of 10MLFresenius Kabi, LLC · May 15, 2025

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

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed
$435.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Medicare Part B (ASP)

Payment limit per 1 MG
$8.188
HCPCS J9065 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$9,116
153 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $2,099.59 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA076571
TE code
AP
Approval date
Apr 22, 2004
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 Cladribine (Injection)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCCLADRIBINE 1 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.CLADRIBINE 1 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Cladribine — NDC 63323-0140-10," retrieved September 3, 2026, https://drugdashboards.com/drug/63323014010.

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