DrugDashboards

Dalbavancin

Dalbavancin · DALBAVANCIN HYDROCHLORIDE 500 mg/25mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Somerset Therapeutics, LLC

NDC 70069-0830-01 · 1 VIAL in 1 CARTON / 25 mL in 1 VIAL · ANDA · 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

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 71288-0034-50) — 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
$1,139.62per unit
middle half $987.70$1,139.62 · 130 plans · Apr 1, 2026
Est. net of rebates
≈ $1,139.62
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
2%of plans cover it
tier 5 · prior auth 1% · step therapy 0% · qty limit 0%

*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 2 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 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA219604
TE code
AP
Approval date
Jun 4, 2026
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 Dalbavancin (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Somerset Therapeutics, LLCDALBAVANCIN HYDROCHLORIDE 500 mg/25mLJul 30, 2026Sep 3, 2026
BE Pharmaceuticals Inc.DALBAVANCIN HYDROCHLORIDE 500 mg/25mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals IncDALBAVANCIN HYDROCHLORIDE 500 mg/25mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Dalbavancin — NDC 70069-0830-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70069083001.

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