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.
Niacin
Niacin · NIACIN 500 mg/1 · Tablet, Film Coated, Extended Release · Oral · Sun Pharmaceutical Industries, Inc.
NDC 47335-0539-08 · 100 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)
0.2%chance of a new FDA shortage posting for niacin (oral solid) in the next 90 days
4 Class I/II recall(s) in 12 months · sole-source market · price up 3% 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
- ANDA200484
- TE code
- AB
- Approval date
- Apr 23, 2014
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · CompletedJan 18, 2024SUN PHARMACEUTICAL INDUSTRIES INC — CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Class II · CompletedJan 18, 2024SUN PHARMACEUTICAL INDUSTRIES INC — CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Manufacturers of Niacin (Tablet, Film Coated, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Amneal Pharmaceuticals LLC | NIACIN 750 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | NIACIN 1000 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | NIACIN 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | NIACIN 750 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, "Niacin — NDC 47335-0539-08," retrieved September 3, 2026, https://drugdashboards.com/drug/47335053908.
Free to cite with attribution — see how the data is put together.