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Heplisav-B

Hepatitis B Vaccine (Recombinant) Adjuvanted · HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mL · Injection, Solution · Intramuscular · Bamboo US BidCo LLC

NDC 83703-0048-05 · 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.

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.

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 83703-0048-05," retrieved September 3, 2026, https://drugdashboards.com/drug/83703004805.

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