NDC 68382-301-30 - Irbesartan
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68382-301
- Requested NDC
- 68382-301-30
- Package NDCs from labels
- 68382-301-06, 68382-301-16, 68382-301-05, 68382-301-10, 68382-301-30, 68382-301-77
- Manufacturer
- Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
- Effective date
- 2022-11-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Irbesartan - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2022-11-10 | HUMAN PRESCRIPTION DRUG LABEL |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Irbesartan | IRBESARTAN | REMEDYREPACK INC. | 0c1fc197-c2d9-453c-b79f-b53de89c188b | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | REMEDYREPACK INC. | bb58acb0-2dc0-45ee-86bb-b405b1b75cff | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 53ce6e4f-db3a-4789-8bef-1e459fa78b79 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | Camber Pharmaceuticals, Inc. | 33416f1e-adee-4a45-b6fe-1fc39044e307 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Teva Pharmaceuticals USA, Inc. | 83f4acc1-697a-4770-b554-1b9a8fb5de74 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Inc. | e842fa14-b18e-4463-9bf1-a1c8700fe33c | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Lotrimin Daily Sweat and Odor Control | TOPICAL STARCH | Bayer HealthCare LLC. | 9ec5c80d-b550-496f-e053-2a95a90a5489 | 2026-01-16 | Warnings | O8232NY3SJ |
| Medicated Cornstarch Baby Powder | ACTIVE CORN STARCH | Davion, Inc. | e39032d1-c8cd-4a41-af10-126970b8ad38 | 2025-12-29 | Warnings | O8232NY3SJ |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | 466dd0d2-9815-4c3e-b66b-d0732b3ba8e9 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Unichem Pharmaceuticals (USA), Inc. | 181324c5-256f-4570-a0bb-8bc908deb2e2 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Hikma Pharmaceuticals USA Inc. | 17561aae-f0bc-4ffc-a007-985b17e9baf0 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | Aurobindo Pharma Limited | 2113a901-2612-4557-b86d-3afc006fb8bb | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | Bryant Ranch Prepack | bc07bbf5-b1c6-4854-b6af-e06520c20728 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | Amneal Pharmaceuticals LLC | 8c9bb449-6341-4f24-9d38-6ca952e07122 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan and Hydrochlorothiazide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 46d77ed8-ece2-4f51-b1a4-4a440e2dce2d | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | Bryant Ranch Prepack | 44b72da1-4434-461f-8e3c-264ad46f85df | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | Novadoz Pharmaceuticals LLC | 1f98fd95-e564-45b3-947f-45eba77f2af5 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Avalide | IRBESARTAN AND HYDROCHLOROTHIAZIDE | Sanofi-Aventis U.S. LLC | 0d91895e-c869-4b33-9b83-d55c1ad6317e | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | Bryant Ranch Prepack | 14d85774-2d74-4300-b4bb-c2836db4d5bd | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
| Irbesartan | IRBESARTAN | Solco Healthcare U.S., LLC | 6916c617-92d2-44f5-b968-6267517a2ce6 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | J0E2756Z7N |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.