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.
Gatifloxacin Ophthalmic Solution 0.5%
Gatifloxacin Ophthalmic Solution 0.5% · GATIFLOXACIN ANHYDROUS 5 mg/mL · Solution · Ophthalmic · Caplin Steriles Limited
NDC 65145-0207-01 · 1 BOTTLE in 1 CARTON / 2.5 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 gatifloxacin (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
- analysis · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA213542
- TE code
- AT
- Approval date
- Nov 3, 2021
- 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 Gatifloxacin Ophthalmic Solution 0.5% (Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Caplin Steriles Limited | GATIFLOXACIN ANHYDROUS 5 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, "Gatifloxacin Ophthalmic Solution 0.5% — NDC 65145-0207-01," retrieved September 3, 2026, https://drugdashboards.com/drug/65145020701.
Free to cite with attribution — see how the data is put together.