The short version
4 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.
Azelastine Hydrochloride
Azelastine · AZELASTINE HYDROCHLORIDE 1 mg/mL · Spray, Metered · Nasal · AvKARE
NDC 42291-0094-30 · 1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY · 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.
Estimated fill cost
WAC per package, as filed
$11.62
Reported to Texas DSHS · 2026 annual filing · AvKare
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
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 azelastine (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 →
Regulatory
- Application
- ANDA204660
- TE code
- AB
- Approval date
- Aug 28, 2017
- 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 Azelastine (Spray, Metered)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Amneal Pharmaceuticals LLC | AZELASTINE HYDROCHLORIDE 1 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | AZELASTINE HYDROCHLORIDE 205.5 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | AZELASTINE HYDROCHLORIDE 137 ug/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | AZELASTINE HYDROCHLORIDE 1 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Azelastine Hydrochloride — NDC 42291-0094-30," retrieved September 3, 2026, https://drugdashboards.com/drug/42291009430.
Free to cite with attribution — see how the data is put together.