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.
Levalbuterol Inhalation Solution
Levalbuterol Inhalation Solution · LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL · Solution · Respiratory (Inhalation) · Sun Pharmaceutical Industries, Inc.
NDC 47335-0753-01 · 5 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE · 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)
0.2%chance of a new FDA shortage posting for levalbuterol (other) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market · price up 1% 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 →
Where it's made
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA207820
- TE code
- —
- Approval date
- Nov 5, 2018
- 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 Levalbuterol Inhalation Solution (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Levalbuterol Inhalation Solution — NDC 47335-0753-01," retrieved September 3, 2026, https://drugdashboards.com/drug/47335075301.
Free to cite with attribution — see how the data is put together.