The short version
Just 2 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.
Darifenacin
Darifenacin · DARIFENACIN HYDROBROMIDE 7.5 mg/1 · Tablet, Film Coated, Extended Release · Oral · Aurobindo Pharma Limited
NDC 65862-0861-05 · 500 TABLET, FILM COATED, EXTENDED RELEASE 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 darifenacin (oral solid) in the next 90 days
sole-source market · price up 5% 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
- ANDA206743
- TE code
- AB
- Approval date
- Sep 19, 2016
- 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 Darifenacin (Tablet, Film Coated, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aurobindo Pharma Limited | DARIFENACIN HYDROBROMIDE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | DARIFENACIN HYDROBROMIDE 7.5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | DARIFENACIN HYDROBROMIDE 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | DARIFENACIN HYDROBROMIDE 7.5 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, "Darifenacin — NDC 65862-0861-05," retrieved September 3, 2026, https://drugdashboards.com/drug/65862086105.
Free to cite with attribution — see how the data is put together.