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.
Irbesartan
Irbesartan · IRBESARTAN 75 mg/1 · Tablet, Film Coated · Oral · Hisun Pharmaceuticals USA Inc.
NDC 42658-0121-01 · 30 TABLET, FILM COATED 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 irbesartan (oral solid) 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 →
Where it's made
- analysis · label · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA206194
- TE code
- AB
- Approval date
- Jun 14, 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 Irbesartan (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hisun Pharmaceuticals USA Inc. | IRBESARTAN 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hisun Pharmaceuticals USA Inc. | IRBESARTAN 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hisun Pharmaceuticals USA Inc. | IRBESARTAN 75 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | IRBESARTAN 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | IRBESARTAN 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | IRBESARTAN 75 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sanofi Winthrop Industrie | IRBESARTAN 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sanofi Winthrop Industrie | IRBESARTAN 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sanofi Winthrop Industrie | IRBESARTAN 75 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sanofi-Aventis U.S. LLC | IRBESARTAN 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sanofi-Aventis U.S. LLC | IRBESARTAN 150 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, "Irbesartan — NDC 42658-0121-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42658012101.
Free to cite with attribution — see how the data is put together.