FDA.reportPublic FDA data

NDC 70518-1543-01 - 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
70518-1543
Requested NDC
70518-1543-01
Package NDCs from labels
70518-1543-0, 70518-1543-1, 70518-1543-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Irbesartan - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1543-0Irbesartan90 in 1 BOTTLE, PLASTICTABLET906
70518-1543-1Irbesartan90 in 1 BOTTLE, PLASTICTABLET906

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 5 · 96 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
rxcui: 200096
rxcui: 200095
unii: J0E2756Z7N
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
IrbesartanIRBESARTANMacleods Pharmaceuticals Limitede8635a1c-ae06-4e23-99f7-e704f91d6f432026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
IRBESARTANIRBESARTANHisun Pharmaceuticals USA Inc.61ab1b6e-c849-49ca-a3f0-150774db649d2026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
IrbesartanIRBESARTANREMEDYREPACK INC.5b259fdd-ca4c-49c9-a50d-86066f5b07462026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200094
unii: J0E2756Z7N
IrbesartanIRBESARTANREMEDYREPACK INC.029a90b6-0722-49be-8400-3ec29526aafd2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203071
rxcui: 200095
unii: J0E2756Z7N
IrbesartanIRBESARTANREMEDYREPACK INC.9adacfa2-2814-4deb-9e34-c3b3c8dcd41a2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203071
ndc (package): 70518-1543-0
ndc (package): 70518-1543-1
ndc (product): 70518-1543
ndc11 (package): 70518154301
rxcui: 200096
spl id: 5606c68d-495d-1167-e063-6394a90a2b3c
spl set id: 9adacfa2-2814-4deb-9e34-c3b3c8dcd41a
unii: J0E2756Z7N
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.88aaa2a1-13be-4f56-ace6-66e8990280072026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
IRBESARTANIRBESARTANChartwell RX, LLC6eb0cb56-2e51-45ef-9fd5-5646cf9f78a32026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
IrbesartanIRBESARTANBryant Ranch Prepack7e0ddb7b-80c5-47ab-afee-c74bb735e8292026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
IrbesartanIRBESARTANBryant Ranch Prepack21dd9a41-93c7-470c-94ed-f4c24e3d56332026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5eabb13d-f6fd-4091-9909-c4f0c59222892026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
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

Reported adverse events (FAERS/openFDA)#

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