Irbesartan
Irbesartan · IRBESARTAN 75 mg/1 · Tablet, Film Coated · Sanofi Winthrop Industrie
NDC 53360-1303-00 · 92307 TABLET, FILM COATED in 1 DRUM · DRUG FOR FURTHER PROCESSING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.
Medicare Part D
This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.
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)
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 →
Regulatory
- Application
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- TE code
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- Approval date
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- Patents / exclusivity
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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 53360-1303-00," retrieved September 3, 2026, https://drugdashboards.com/drug/53360130300.
Free to cite with attribution — see how the data is put together.