FDA.reportPublic FDA data

NDC 71335-2168-01 - 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
71335-2168
Requested NDC
71335-2168-01
Package NDCs from labels
71335-2168-1, 71335-2168-2, 71335-2168-3, 71335-2168-01
Manufacturer
Bryant Ranch Prepack
Effective date
2023-11-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Irbesartan - Bryant Ranch PrepackBryant Ranch Prepack2023-11-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2168-1Irbesartan30 in 1 BOTTLETABLET30101
71335-2168-2Irbesartan60 in 1 BOTTLETABLET60101
71335-2168-3Irbesartan90 in 1 BOTTLETABLET90101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2168IRBESARTAN TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 3 package rows20231128_1ab1ff46-d0b1-4762-9ebf-3e07dde8b048.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 2 of 5 · 94 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IrbesartanIRBESARTANPreferred Pharmaceuticals Inc.197871da-e0c5-49a9-8dd0-34a8c2685c6b2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200095
unii: J0E2756Z7N
IRBESARTANIRBESARTANJubilant Cadista Pharmaceuticals Inc.068224c4-a34d-32d7-bb2a-7eed44ccf7d32026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5029c9f7-6233-4a6f-ace9-2268cc8e286d2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
IrbesartanIRBESARTANNorthStar RxLLC08c85ada-de6f-4cff-bc81-2332a22bef452026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
rxcui: 200095
rxcui: 200094
unii: J0E2756Z7N
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC72fa8cd4-bc2a-4a7d-8feb-2d60e077d8012026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: J0E2756Z7N
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
IrbesartanIRBESARTANREMEDYREPACK INC.0c1fc197-c2d9-453c-b79f-b53de89c188b2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200095
unii: J0E2756Z7N
IrbesartanIRBESARTANREMEDYREPACK INC.bb58acb0-2dc0-45ee-86bb-b405b1b75cff2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200096
unii: J0E2756Z7N
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
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
rxcui: 200096
rxcui: 200095
rxcui: 200094
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
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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