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 table
LabelManufacturerEffective dateType
Irbesartan - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2022-11-10HUMAN 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.

Matched openFDA labels page 2 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IrbesartanIRBESARTANREMEDYREPACK INC.0c1fc197-c2d9-453c-b79f-b53de89c188b2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANREMEDYREPACK INC.bb58acb0-2dc0-45ee-86bb-b405b1b75cff2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53ce6e4f-db3a-4789-8bef-1e459fa78b792026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANCamber Pharmaceuticals, Inc.33416f1e-adee-4a45-b6fe-1fc39044e3072026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.83f4acc1-697a-4770-b554-1b9a8fb5de742026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAlembic Pharmaceuticals Inc.e842fa14-b18e-4463-9bf1-a1c8700fe33c2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited466dd0d2-9815-4c3e-b66b-d0732b3ba8e92025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.181324c5-256f-4570-a0bb-8bc908deb2e22025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEHikma Pharmaceuticals USA Inc.17561aae-f0bc-4ffc-a007-985b17e9baf02025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANAurobindo Pharma Limited2113a901-2612-4557-b86d-3afc006fb8bb2025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANBryant Ranch Prepackbc07bbf5-b1c6-4854-b6af-e06520c207282025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANAmneal Pharmaceuticals LLC8c9bb449-6341-4f24-9d38-6ca952e071222025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack46d77ed8-ece2-4f51-b1a4-4a440e2dce2d2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANBryant Ranch Prepack44b72da1-4434-461f-8e3c-264ad46f85df2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANNovadoz Pharmaceuticals LLC1f98fd95-e564-45b3-947f-45eba77f2af52025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
AvalideIRBESARTAN AND HYDROCHLOROTHIAZIDESanofi-Aventis U.S. LLC0d91895e-c869-4b33-9b83-d55c1ad6317e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANBryant Ranch Prepack14d85774-2d74-4300-b4bb-c2836db4d5bd2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANSolco Healthcare U.S., LLC6916c617-92d2-44f5-b968-6267517a2ce62025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.