The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Diflunisal
Diflunisal · DIFLUNISAL 500 mg/1 · Tablet · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC 68382-0530-01 · 100 TABLET 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 diflunisal (oral solid) 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
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA203547
- TE code
- AB
- Approval date
- Jun 16, 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 Diflunisal (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Cohance Lifesciences Limited | DIFLUNISAL 25 kg/25kg | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | DIFLUNISAL 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals (USA) Inc. | DIFLUNISAL 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Diflunisal — NDC 68382-0530-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68382053001.
Free to cite with attribution — see how the data is put together.