DrugDashboards

Heplisav-B

Hepatitis B Vaccine (Recombinant) Adjuvanted · HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mL · Injection, Solution · Intramuscular · Dynavax Technologies Corporation

NDC 43528-0003-05 · 5 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE · BLA · View full market →

The short version

Just 3 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.

  • Part D plans paid (avg)$307.71per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal ceiling (Big4)$483.33per package of 5X0.5MLDynavax Technologies Corporation · Jan 1, 2026
  • List price (WAC, as filed)$825.48per packageDynavax Technologies Corporation · Jan 15, 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

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

Estimated fill cost

WAC per package, as filed
$778.75
Reported to Texas DSHS · 2026 annual filing · Dynavax Technologies Corporation

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

Supply fragility

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

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 $157.13 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA125428
TE code
Approval date
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 Hepatitis B Vaccine (Recombinant) Adjuvanted (Injection, Solution)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mLJul 15, 2026Sep 2, 2026
Bamboo US BidCo LLCHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mLJul 15, 2026Sep 2, 2026
Dynavax Technologies CorporationHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Heplisav-B — NDC 43528-0003-05," retrieved September 3, 2026, https://drugdashboards.com/drug/43528000305.

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