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.
Dorzolamide hydrochloride
Dorzolamide hydrochloride · DORZOLAMIDE HYDROCHLORIDE 20 mg/mL · Solution · Ophthalmic · Leading Pharma, LLC
NDC 69315-0304-05 · 1 BOTTLE in 1 CARTON / 5 mL 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 dorzolamide hydrochloride (other) in the next 90 days
OAI inspection at a producing facility (24 months) · 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
- ANDA205294
- TE code
- AT
- Approval date
- Jan 24, 2019
- 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 Dorzolamide hydrochloride (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Advagen Pharma Ltd. | DORZOLAMIDE HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Fosun Pharma Usa Inc | DORZOLAMIDE HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | DORZOLAMIDE HYDROCHLORIDE 20 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Leading Pharma, LLC | DORZOLAMIDE HYDROCHLORIDE 20 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, "Dorzolamide hydrochloride — NDC 69315-0304-05," retrieved September 3, 2026, https://drugdashboards.com/drug/69315030405.
Free to cite with attribution — see how the data is put together.