FDA.reportPublic FDA data

NDC 68382-299-30 - 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
68382-299
Requested NDC
68382-299-30
Package NDCs from labels
68382-299-06, 68382-299-16, 68382-299-05, 68382-299-10, 68382-299-30, 68382-299-77
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 1 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AvaproIRBESARTANSanofi-Aventis U.S. LLC7885b2a8-be4e-48ab-8113-4e6ab791eb982026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANMacleods Pharmaceuticals Limitede8635a1c-ae06-4e23-99f7-e704f91d6f432026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IRBESARTANIRBESARTANHisun Pharmaceuticals USA Inc.61ab1b6e-c849-49ca-a3f0-150774db649d2026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANREMEDYREPACK INC.5b259fdd-ca4c-49c9-a50d-86066f5b07462026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANREMEDYREPACK INC.029a90b6-0722-49be-8400-3ec29526aafd2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANREMEDYREPACK INC.9adacfa2-2814-4deb-9e34-c3b3c8dcd41a2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.88aaa2a1-13be-4f56-ace6-66e8990280072026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IRBESARTANIRBESARTANChartwell RX, LLC6eb0cb56-2e51-45ef-9fd5-5646cf9f78a32026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANBryant Ranch Prepack7e0ddb7b-80c5-47ab-afee-c74bb735e8292026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANBryant Ranch Prepack21dd9a41-93c7-470c-94ed-f4c24e3d56332026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5eabb13d-f6fd-4091-9909-c4f0c59222892026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack85494404-484c-45a1-8487-f9eb2a76490d2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke6c35575-9c3f-42f8-b8b8-577a29f9d3812026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANPreferred Pharmaceuticals Inc.197871da-e0c5-49a9-8dd0-34a8c2685c6b2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.068224c4-a34d-32d7-bb2a-7eed44ccf7d32026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5029c9f7-6233-4a6f-ace9-2268cc8e286d2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
IrbesartanIRBESARTANNorthStar RxLLC08c85ada-de6f-4cff-bc81-2332a22bef452026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC72fa8cd4-bc2a-4a7d-8feb-2d60e077d8012026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N

Reported adverse events (FAERS/openFDA)#

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