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.
Buprenorphine and Naloxone
buprenorphine and naloxone · BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE .5 mg/1 · Film · Buccal; Sublingual · Redpharm Drug
NDC 67296-2228-01 · 6 POUCH in 1 CARTON / 1 FILM in 1 POUCH · 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 (other) 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 →
Where it's made
- RedPharm DrugUnited Statesrepack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
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
- ANDA212756
- TE code
- AB
- Approval date
- Jun 2, 2022
- 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 (Film)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Redpharm Drug | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Alvogen Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alvogen Inc. | BUPRENORPHINE HYDROCHLORIDE 12 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 3 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alvogen Inc. | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alvogen Inc. | BUPRENORPHINE HYDROCHLORIDE 4 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aveva Drug Delivery Systems Inc. | BUPRENORPHINE HYDROCHLORIDE 12 mg/1; NALOXONE HYDROCHLORIDE 3 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aveva Drug Delivery Systems Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aveva Drug Delivery Systems Inc. | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aveva Drug Delivery Systems Inc. | BUPRENORPHINE HYDROCHLORIDE 4 mg/1; NALOXONE HYDROCHLORIDE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, Llc | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, Llc | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, Llc | BUPRENORPHINE HYDROCHLORIDE 4 mg/1; NALOXONE HYDROCHLORIDE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, Llc | BUPRENORPHINE HYDROCHLORIDE 12 mg/1; NALOXONE HYDROCHLORIDE 3 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | BUPRENORPHINE HYDROCHLORIDE 12 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 3 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | BUPRENORPHINE HYDROCHLORIDE 4 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 1 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Redpharm Drug | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Redpharm Drug | BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE .5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Buprenorphine and Naloxone — NDC 67296-2228-01," retrieved September 3, 2026, https://drugdashboards.com/drug/67296222801.
Free to cite with attribution — see how the data is put together.