FDA.reportPublic FDA data

NDC 55154-7991-00 - 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
55154-7991
Requested NDC
55154-7991-00
Package NDCs from labels
55154-7991-0, 55154-7991-00
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isosorbide Dinitrate - Cardinal Health 107, LLCCardinal Health 107, LLC2026-05-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7991-0Isosorbide Dinitrate1 in 1 BLISTER PACKTABLET110
55154-7991-0Isosorbide Dinitrate10 in 1 BAGTABLET1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7991ISOSORBIDE DINITRATE TABLET [CARDINAL HEALTH 107, LLC]8Current NDC, Legacy NDC, 2 package rows20250112_5f585259-59ed-4648-b562-164f3746c821.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 · 37 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: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEPar Health USA, LLC3d6164d7-3083-41c5-a6a6-7e144fe29f7d2026-07-22Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATECardinal Health 107, LLC5f585259-59ed-4648-b562-164f3746c8212026-05-19Warnings, Adverse reactionsExact identifier
application number: ANDA088088
ndc (package): 55154-7990-0
ndc (package): 55154-7991-0
ndc (product): 55154-7990
ndc (product): 55154-7991
ndc11 (package): 55154799100
rxcui: 381056
rxcui: 206842
spl id: cba216c7-9a4b-4107-b619-88c5ebd2df2d
spl set id: 5f585259-59ed-4648-b562-164f3746c821
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEMajor Pharmaceuticals6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb2026-03-13Warnings, Adverse reactionsExact identifier
application number: ANDA088088
ndc (product): 0904-6619
ndc (product): 0904-6620
rxcui: 381056
rxcui: 206842
spl id: 43289136-625e-4671-b4c8-bb523c11b132
spl set id: 6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb
unii: IA7306519N
Gout Symptom ReliefAMMON PHOS, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA AND URTICA URENS.King Bio Inc.41dc03fc-169b-4691-bd62-9a41d7a6d2f72026-03-06WarningsExact identifier
unii: 10LGE70FSU
Isosorbide DinitrateISOSORBIDE DINITRATEAvPAK0e5842f2-74f6-1f02-01bc-07578bd3b3932026-02-10Warnings, Adverse reactionsExact identifier
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
application number: ANDA088088
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Small Joint Pain Drops 2038SMALL JOINT PAIN DROPSProfessional Complementary Health Formulasf6bf9ea0-61b3-4bfe-b167-0a0c146581672026-01-08WarningsExact identifier
unii: 10LGE70FSU
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEAdvagen Pharma Ltdb166eb5b-bad8-4663-9c05-1c43539dab2c2026-01-05Warnings, Adverse reactionsExact identifier
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEHikma Pharmaceuticals USA Inc.f0b9b320-0bf8-4342-b654-135ccb6755c22025-12-05Warnings, Adverse reactionsExact identifier
application number: ANDA088088
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
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
D-101WORMWOOD, ARSENIC TRIOXIDE, GARLIC, AMOEBA PROTEUS, AMMONIUM PHOSPHATE, DIBASIC, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, AND VERATRUM ALBUM ROOTDNA Labs, Inc.d829481b-110e-4be7-87ef-910bd248454c2025-01-13WarningsExact identifier
unii: 10LGE70FSU
Ammonium PhosphoricumAMMONIUM PHOSPHORICUMHahnemann Laboratories, Inc.b25e39bd-7e81-1ef1-e053-2995a90a6d822025-01-09Exact identifier
unii: 10LGE70FSU
Isosorbide DinitrateISOSORBIDE DINITRATEBryant Ranch Prepack73a1e6c0-71d0-4ba1-bbca-c067479e487d2024-10-08Warnings, Adverse reactionsExact identifier
unii: IA7306519N

Reported adverse events (FAERS/openFDA)#

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