DrugDashboards

Udenyca

pegfilgrastim-cbqv · PEGFILGRASTIM 6 mg/.6mL · Injection, Solution · Subcutaneous · Accord BioPharma, Inc.

NDC 69448-0026-63 · 1 SYRINGE in 1 CARTON / .6 mL in 1 SYRINGE · BLA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. A Class I recall hit this product in the past year (McKesson).

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 70114-0101-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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
$6,917.98per unit
middle half $6,541.93$6,982.83 · 2,242 plans · Apr 1, 2026
Est. net of rebates
$4,150.79–$5,188.48
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
41%of plans cover it
tier 5 · prior auth 96% · step therapy 0% · qty limit 41%

*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 10 quarters since 2024.

NADAC price per unit

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

Supply fragility

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

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 $4,673.92 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA761039
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 I · OngoingJan 16, 2026
    McKessonTemperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.

Manufacturers of pegfilgrastim-cbqv (Injection, Solution)

LabelerStrengthFirst seenLast seen
Accord BioPharma, Inc.PEGFILGRASTIM 6 mg/.6mLJul 15, 2026Sep 3, 2026
Coherus Oncology, Inc.PEGFILGRASTIM 6 mg/.6mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Udenyca — NDC 69448-0026-63," retrieved September 3, 2026, https://drugdashboards.com/drug/69448002663.

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