DrugDashboards

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride · BUPRENORPHINE HYDROCHLORIDE .324 mg/mL · Injection · Intramuscular; Intravenous · Par Health USA, LLC

NDC 42023-0179-05 · 5 VIAL in 1 CARTON / 1 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. 2 Class II recalls hit this product in the past year (Par Health USA, LLC).

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.

Estimated fill cost

WAC per package, as filed
$68.10
Reported to Texas DSHS · 2026 annual filing · Par Health USA, LLC

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

Medicare Part B (ASP)

Payment limit per 0.1 MG
$4.474
HCPCS J0592 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$6,493
489 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Brixadi

Regulatory

Application
ANDA206586
TE code
AP
Approval date
Jul 28, 2015
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJun 12, 2026
    Par Health USA, LLC — Crystallization; identified as Buprenorphine free base
  • Class II · OngoingMar 13, 2026
    ENDO USA, Inc. — Crystallization; identified as Buprenorphine free base
  • Class II · TerminatedNov 9, 2021
    PAR Sterile Products LLC — Crystallization; identified as Buprenorphine free base
  • Class II · TerminatedApr 28, 2017
    PAR Sterile Products LLC — Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.

Manufacturers of Buprenorphine Hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Hikma Pharmaceuticals USA Inc.BUPRENORPHINE HYDROCHLORIDE .324 mg/mLJul 15, 2026Sep 2, 2026
Par Health USA, LLCBUPRENORPHINE HYDROCHLORIDE .324 mg/mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LLCBUPRENORPHINE HYDROCHLORIDE .324 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Buprenorphine Hydrochloride — NDC 42023-0179-05," retrieved September 3, 2026, https://drugdashboards.com/drug/42023017905.

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