The short version
14 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Buprenorphine and Naloxone
Buprenorphine and Naloxone · BUPRENORPHINE 8 mg/1; NALOXONE 2 mg/1 · Tablet · Sublingual · Bryant Ranch Prepack
NDC 71335-1378-00 · 42 TABLET in 1 BOTTLE · ANDA · View full market →
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 and naloxone (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
- ANDA205022
- TE code
- AB
- Approval date
- Sep 19, 2016
- 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 and Naloxone (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bryant Ranch Prepack | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Actavis Pharma, Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| American Health Packaging | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvPAK | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvPAK | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | BUPRENORPHINE 8 mg/1; NALOXONE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | BUPRENORPHINE 2 mg/1; NALOXONE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | BUPRENORPHINE 8 mg/1; NALOXONE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | BUPRENORPHINE 2 mg/1; NALOXONE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Redpharm Drug | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Remedyrepack Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rhodes Pharmaceuticals LLC | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rhodes Pharmaceuticals LLC | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Unit Dose Solutions, Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Buprenorphine and Naloxone — NDC 71335-1378-00," retrieved September 3, 2026, https://drugdashboards.com/drug/71335137800.
Free to cite with attribution — see how the data is put together.