FDA.reportPublic FDA data

NDC 70771-1501-01 - Isosorbide dinitrate

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
70771-1501
Requested NDC
70771-1501-01
Package NDCs from labels
70771-1501-1, 70771-1501-0, 70771-1501-01
Manufacturer
Zydus Lifesciences Limited
Effective date
2023-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isosorbide dinitrate - Zydus Lifesciences LimitedZydus Lifesciences Limited2023-11-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1501-0Isosorbide dinitrate1000 in 1 BOTTLETABLET10003
70771-1501-1Isosorbide dinitrate100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1501ISOSORBIDE DINITRATE TABLET [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 2 package rows20231108_5b0db8af-bcf9-458f-b752-420130cba428.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 1 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isosorbide DinitrateISOSORBIDE DINITRATEPar Health USA, LLC6df6a2fa-c56c-4eb6-a485-c16585420eb02026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 197839
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEPar Health USA, LLC3d6164d7-3083-41c5-a6a6-7e144fe29f7d2026-07-22Warnings, Adverse reactionsExact identifier
rxcui: 197840
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATECardinal Health 107, LLC5f585259-59ed-4648-b562-164f3746c8212026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEMajor Pharmaceuticals6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb2026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEAvPAK0e5842f2-74f6-1f02-01bc-07578bd3b3932026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEREMEDYREPACK INC.829ed058-333f-453c-9f0e-9202e03acf972026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 381056
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEGolden State Medical Supply, Inc.7f860fbd-f130-4652-e053-2991aa0a402e2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEAdvagen Pharma Ltdb166eb5b-bad8-4663-9c05-1c43539dab2c2026-01-05Warnings, Adverse reactionsExact identifier
rxcui: 197839
rxcui: 197840
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEHikma Pharmaceuticals USA Inc.f0b9b320-0bf8-4342-b654-135ccb6755c22025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
BiDilHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEAzurity Pharmaceuticals, Inc.e1e63cd5-d1e4-4af5-bad5-1ad41ea46b002025-11-30Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEAmerican Health Packaging5c94ecc0-fcaa-4af3-82c2-ff124f2df3e12025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide dinitrateISOSORBIDE DINITRATENorthstar Rx LLC246c749d-aa28-44ce-8d42-984660afff2a2025-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA213057
rxcui: 197839
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC8f54d5a3-169f-48dd-9250-2c176d2bd9ad2025-06-03Warnings, Adverse reactionsExact identifier
unii: IA7306519N
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEA2A Integrated Pharmaceuticalsae757a78-89e8-4f79-81de-d558db3f72a42025-02-28Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEBryant Ranch Prepack73a1e6c0-71d0-4ba1-bbca-c067479e487d2024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 197840
unii: IA7306519N
Isosorbide dinitrateISOSORBIDE DINITRATEBluePoint Laboratoriesf1d52e9a-8de1-61db-e053-2a95a90aae502024-09-17Warnings, Adverse reactionsExact identifier
application number: ANDA213057
rxcui: 197839
unii: IA7306519N
Isosorbide dinitrateISOSORBIDE DINITRATEZydus Pharmaceuticals (USA) Inc.16818b32-ee5e-4e07-b848-31e892c4b98a2024-08-08Warnings, Adverse reactionsExact identifier
application number: ANDA213057
rxcui: 197839
rxcui: 197840
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEProficient Rx LP1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b202024-08-01Warnings, Adverse reactionsExact identifier
rxcui: 206842
unii: IA7306519N
isosorbide dinitrate and hydralazine hydrochlorideHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEBryant Ranch Prepack2a6fe05a-fcd4-42d1-bf5d-1d39ac2733632024-07-01Warnings, Adverse reactionsExact identifier
unii: IA7306519N

Reported adverse events (FAERS/openFDA)#

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