DrugDashboards

Inflectra

infliximab-dyyb · INFLIXIMAB 100 mg/10mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Pfizer Laboratories Div Pfizer Inc

NDC 00069-0809-01 · 1 VIAL, SINGLE-USE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-USE · BLA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. 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)$491.55per EAinvoice-surveyed acquisition cost · Mar 19, 2025
  • Medicare Part B pays (ASP+6%)$27.71per billing unit (10 MG)HCPCS Q5103 · Jul 1, 2026
  • Part D plans paid (avg)$737.48per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$293.86per package of 20MLPfizer Inc. · Jan 1, 2026

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$200.00$400.00$600.00Oct 2024Mar 2025$491.55
7 price points · per EA · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$946.28
Reported to Texas DSHS · 2026 annual filing · Pfizer Inc.

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

Medicare Part B (ASP)

Payment limit per 10 MG
$27.710
HCPCS Q5103 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$45.2M
22,908 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.

  • 2 active manufacturers+20
  • sterile injectable+10

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

Is this a "specialty" drug?

There's no legal definition — it meets 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $5,329.06 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA125544
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJan 17, 2025
    McKessoncGMP Deviations: Product intended for quarantine was inadvertently distributed.

Manufacturers of infliximab-dyyb (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
CELLTRION, Inc.INFLIXIMAB-DYYB 100 mg/10mLJul 15, 2026Sep 2, 2026
CELLTRION, Inc.INFLIXIMAB-DYYB 9 kg/9kgJul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncINFLIXIMAB 100 mg/10mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Inflectra — NDC 00069-0809-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00069080901.

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