DrugDashboards

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride · BUPRENORPHINE HYDROCHLORIDE .324 mg/mL · Injection · Intramuscular; Intravenous · Hikma Pharmaceuticals USA Inc.

NDC 00143-9246-05 · 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.

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

Regulatory

Application
ANDA076931
TE code
AP
Approval date
Mar 2, 2005
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedAug 14, 2020
    Hikma Pharmaceuticals USA Inc. — Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.

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 00143-9246-05," retrieved September 3, 2026, https://drugdashboards.com/drug/00143924605.

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