DrugDashboards

buprenorphine hydrochloride

buprenorphine hydrochloride · BUPRENORPHINE HYDROCHLORIDE 4 mg/1 · Tablet · Sublingual · Advagen Pharma Ltd

NDC 72888-0509-01 · 30 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble.

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.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for buprenorphine hydrochloride (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

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 · Brixadi

Regulatory

Application
ANDA090279
TE code
AB
Approval date
Jun 10, 2015
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 buprenorphine hydrochloride (Tablet)

LabelerStrengthFirst seenLast seen
PAI Holdings, LLC dba PAI PharmaBUPRENORPHINE HYDROCHLORIDE 2 mg/1Aug 13, 2026Sep 3, 2026
PAI Holdings, LLC dba PAI PharmaBUPRENORPHINE HYDROCHLORIDE 8 mg/1Aug 13, 2026Sep 3, 2026
A-S Medication SolutionsBUPRENORPHINE HYDROCHLORIDE 8 mg/1Jul 15, 2026Sep 2, 2026
Advagen Pharma LtdBUPRENORPHINE HYDROCHLORIDE 12 mg/1Jul 22, 2026Sep 2, 2026
Advagen Pharma LtdBUPRENORPHINE HYDROCHLORIDE 2 mg/1Jul 15, 2026Sep 2, 2026
Advagen Pharma LtdBUPRENORPHINE HYDROCHLORIDE 4 mg/1Jul 22, 2026Sep 2, 2026
Advagen Pharma LtdBUPRENORPHINE HYDROCHLORIDE 8 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.BUPRENORPHINE HYDROCHLORIDE 8 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.BUPRENORPHINE HYDROCHLORIDE 2 mg/1Jul 15, 2026Sep 2, 2026
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaBUPRENORPHINE HYDROCHLORIDE 8 mg/1Jul 15, 2026Aug 12, 2026
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI PharmaBUPRENORPHINE HYDROCHLORIDE 2 mg/1Jul 15, 2026Aug 12, 2026

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

Cite this page

DrugDashboards, "buprenorphine hydrochloride — NDC 72888-0509-01," retrieved September 3, 2026, https://drugdashboards.com/drug/72888050901.

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