FDA.reportPublic FDA data

NDC 70710-1148-01 - 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
70710-1148
Requested NDC
70710-1148-01
Package NDCs from labels
70710-1148-1, 70710-1148-0, 70710-1148-01
Manufacturer
Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited
Effective date
2024-08-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isosorbide Dinitrate Tablets, USP RX OnlyZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2024-08-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1148-0Isosorbide dinitrate1000 in 1 BOTTLETABLET10004
70710-1148-1Isosorbide dinitrate100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1148ISOSORBIDE DINITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 2 package rows20240809_16818b32-ee5e-4e07-b848-31e892c4b98a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1148-1EA - Each70710-11488161ad45-78d4-40be-859f-527f077117eb12020-01-03

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 · 31 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
application number: ANDA213057
rxcui: 197839
rxcui: 197840
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 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: 197840
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.