FDA.reportPublic FDA data

NDC 68084-082-11 - 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
68084-082
Requested NDC
68084-082-11
Package NDCs from labels
68084-082-11, 68084-082-01
Manufacturer
American Health Packaging
Effective date
2025-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isosorbide Dinitrate - American Health PackagingAmerican Health Packaging2025-10-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-082-01Isosorbide Dinitrate100 in 1 BOX, UNIT-DOSETABLET10010
68084-082-11Isosorbide Dinitrate1 in 1 BLISTER PACKTABLET110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-082ISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 2 package rows20241215_5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-082-01EA - Each68084-08263584b9c-11ab-40be-892b-6f5c9b18817912013-11-04
68084-082-11EA - Each68084-0822350f595-bb40-48c5-b4d1-4d1029340c9b12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE DINITRATEACTIVE INGREDIENTIA7306519NISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]1
ISOSORBIDE DINITRATEACTIVE MOIETYIA7306519NISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISOSORBIDE DINITRATE TABLET [AMERICAN HEALTH PACKAGING]1

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEProficient Rx LP33d14f59-3ae8-4414-b826-06274cf0f3d92024-07-01Warnings, Adverse reactionsExact identifier
rxcui: 381056
unii: IA7306519N
isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEi3 Pharmaceuticals, LLCcacf1a7c-0388-09ee-e053-2995a90a10cf2024-05-16Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATESandoz Inc.71fdd147-a987-40b6-9f07-82d56525ceb82024-02-01Warnings, Adverse reactionsExact identifier
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Isosorbide dinitrateISOSORBIDE DINITRATEZydus Lifesciences Limited5b0db8af-bcf9-458f-b752-420130cba4282023-11-07Warnings, Adverse reactionsExact identifier
rxcui: 197839
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
ISOSORBIDE DINITRATEISOSORBIDE DINITRATENCS HealthCare of KY, LLC dba Vangard Labs74a7f767-fa2f-4640-be24-34a8a91282172023-05-22Warnings, Adverse reactionsExact identifier
rxcui: 197839
rxcui: 381056
rxcui: 206842
unii: IA7306519N
isosorbide dinitrate and hydralazine hydrochlorideHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEWilshire Pharmaceuticals620a0680-aad0-4923-84be-7393c0cbdcbd2022-04-14Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEOceanside Pharmaceuticals723d9f78-9d77-4575-af27-1aa117e6b8d72020-03-02Warnings, Adverse reactionsExact identifier
rxcui: 314055
unii: IA7306519N
IsosorbideISOSORBIDE DINITRATEBluePoint Laboratories9498fa14-1614-4a8e-b872-41c11745b01e2018-11-30Warnings, Adverse reactionsExact identifier
rxcui: 314055
rxcui: 381056
rxcui: 206842
unii: IA7306519N

Reported adverse events (FAERS/openFDA)#

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