The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Breztri
budesonide, glycopyrrolate, and formoterol fumarate · BUDESONIDE 160 ug/1; GLYCOPYRROLATE 18 ug/1; FORMOTEROL 4.8 ug/1 · Aerosol, Metered · Respiratory (Inhalation) · AstraZeneca Pharmaceuticals LP
NDC 00310-6616-01 · 120 AEROSOL, METERED in 1 INHALER · NDA · 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 budesonide, glycopyrrolate, and formoterol fumarate (other) in the next 90 days
sole-source market · price up 3% YoY
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 →
Regulatory
- Application
- NDA212122
- TE code
- —
- Approval date
- Jul 23, 2020
- Patents / exclusivity
- 18 patents, 1 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | NS | Apr 27, 2029 |
| patent | 11331442 | Oct 5, 2038 |
| patent | 11331442 | Oct 5, 2038 |
| patent | 11833292 | Oct 5, 2038 |
| patent | 11833292 | Oct 5, 2038 |
| patent | 8815258 | Mar 17, 2031 |
| patent | 8815258 | Mar 17, 2031 |
| patent | 8324266 | May 28, 2030 |
| patent | 8703806 | May 28, 2030 |
| patent | 8808713 | May 28, 2030 |
| patent | 8703806 | May 28, 2030 |
| patent | 9415009 | May 28, 2030 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of budesonide, glycopyrrolate, and formoterol fumarate (Aerosol, Metered)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | BUDESONIDE 160 ug/1; GLYCOPYRROLATE 18 ug/1; FORMOTEROL 4.8 ug/1 | Aug 26, 2026 | Sep 2, 2026 |
| AstraZeneca Pharmaceuticals LP | BUDESONIDE 160 ug/1; GLYCOPYRROLATE 9 ug/1; FORMOTEROL 4.8 ug/1 | Aug 26, 2026 | Sep 2, 2026 |
| AstraZeneca Pharmaceuticals LP | BUDESONIDE 160 ug/1; GLYCOPYRROLATE 4.8 ug/1; FORMOTEROL 18 ug/1 | Jul 22, 2026 | Aug 19, 2026 |
| AstraZeneca Pharmaceuticals LP | BUDESONIDE 160 ug/1; GLYCOPYRROLATE 4.8 ug/1; FORMOTEROL 9 ug/1 | Jul 22, 2026 | Aug 19, 2026 |
| AstraZeneca Pharmaceuticals LP | BUDESONIDE 160 ug/1; FORMOTEROL 4.8 ug/1; GLYCOPYRROLATE 18 ug/1 | Jul 15, 2026 | Jul 15, 2026 |
| AstraZeneca Pharmaceuticals LP | BUDESONIDE 160 ug/1; FORMOTEROL 4.8 ug/1; GLYCOPYRROLATE 9 ug/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Breztri — NDC 00310-6616-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00310661601.
Free to cite with attribution — see how the data is put together.