FDA.reportPublic FDA data

NDC 70518-1690-01 - 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
70518-1690
Requested NDC
70518-1690-01
Package NDCs from labels
70518-1690-0, 70518-1690-1, 70518-1690-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-10
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.2026-07-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1690-0Irbesartan90 in 1 BOTTLE, PLASTICTABLET9010
70518-1690-1Irbesartan90 in 1 BOTTLE, PLASTICTABLET9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1690IRBESARTAN TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250227_029a90b6-0722-49be-8400-3ec29526aafd.zip

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 3 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: 3NXW29V3WO
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: 3NXW29V3WO
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
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO
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
rxcui: 200096
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
IrbesartanIRBESARTANBryant Ranch Prepackbc07bbf5-b1c6-4854-b6af-e06520c207282025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200095
unii: J0E2756Z7N
IrbesartanIRBESARTANAmneal Pharmaceuticals LLC8c9bb449-6341-4f24-9d38-6ca952e071222025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
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
rxcui: 200096
unii: J0E2756Z7N
IrbesartanIRBESARTANNovadoz Pharmaceuticals LLC1f98fd95-e564-45b3-947f-45eba77f2af52025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
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
application number: ANDA203071
rxcui: 200094
unii: J0E2756Z7N
IrbesartanIRBESARTANSolco Healthcare U.S., LLC6916c617-92d2-44f5-b968-6267517a2ce62025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203071
ndc (product): 43547-375
rxcui: 200096
rxcui: 200095
rxcui: 200094
spl id: 9dd3ba36-25b6-45da-906f-316049b9f23b
spl set id: 6916c617-92d2-44f5-b968-6267517a2ce6
unii: J0E2756Z7N
IRBESARTANIRBESARTANAlembic Pharmaceuticals Inc.83f5d5c8-27c0-4208-a291-0c4aa55a1ff52025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
IRBESARTANIRBESARTANAvKARE2d80abcb-c995-82bc-e063-6294a90aa5302025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1898f438-4571-4aab-ae06-9bf1aabf04862025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N

Reported adverse events (FAERS/openFDA)#

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