FDA.reportPublic FDA data

NDC 0258-3613 - 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
0258-3613
Package NDCs from labels
0258-3613-01, 0258-3613-10
Manufacturer
Physicians Total Care, Inc.
Effective date
2010-11-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isosorbide Dinitrate - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-11-08HUMAN PRESCRIPTION DRUG LABEL
ISOSORBIDE DINITRATE Extended-release Tablets, USPInwood Laboratories, Inc.2006-10-08HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0258-3613-01Isorbide Dinitrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
0258-3613-10Isorbide Dinitrate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0258-3613ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]12 package rows20070726_11fa7725-cb19-46f6-9468-01a0a430492c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Isosorbide dinitrateACTIVE INGREDIENTIA7306519NISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]1
ISOSORBIDE DINITRATEACTIVE INGREDIENTIA7306519NISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ISOSORBIDEACTIVE MOIETYWXR179L51SISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
Isosorbide dinitrateACTIVE MOIETYIA7306519NISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]1
anhydrous lactoseINACTIVE INGREDIENTISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
colloidal silicon dioxideINACTIVE INGREDIENTISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C Yellow #6 Aluminum LakeINACTIVE INGREDIENTISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
hydroxypropyl methylcelluloseINACTIVE INGREDIENTISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]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 15 of 33 · 659 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD3fb16579-7cf1-873a-e063-6294a90a9ac12025-09-26WarningsExact identifier
unii: ETJ7Z6XBU4
Vax-SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI, MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICANutritional Specialties, Inc.cd570e98-c73f-4b38-b5b9-9f16f745ca192025-09-22WarningsExact identifier
unii: ETJ7Z6XBU4
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c334fbd-0c1e-eac0-e053-2995a90a92832025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c348fa7-1d68-4975-e053-2995a90a0ca62025-09-19WarningsExact identifier
unii: ETJ7Z6XBU4
Owell Naturals Draw Salve, Arnica, SiliceaARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1c9dab31-de1f-911b-e063-6294a90a03912025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4
Owell Naturals Draw SalveARNICA MONTANA HPUS, SILICEA HPUSOwell Naturals Brand LLC1536ff1e-16b8-fbbc-e063-6394a90a628e2025-09-12WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltd9083a01b-2fbe-4e04-9eec-bf4f65950ec72025-09-09WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb 12 General TonicCALCAREA FLUORICA,CALCAREA PHOSPHORICA,CALCAREA SULPHURICA,FERRUM PHOSPHORICUM ,KALI PHOSPHORICUM,KALI MURIATICUM,KALI SULPHURICUM,MAGNESIA PHOSPHORICA,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAMartin & Pleasance Pty Ltdc14c79ab-85bb-45f2-83d1-1d9c298ffdfd2025-09-08WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy and Sinus ReliefPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDESchwabe North American, Inc.c90cc6f5-14ec-41a3-a20a-4e8018bb02fb2025-08-25WarningsExact identifier
unii: ETJ7Z6XBU4
Isosorbide dinitrateISOSORBIDE DINITRATENorthstar Rx LLC246c749d-aa28-44ce-8d42-984660afff2a2025-08-21Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Inc.0c3ed6fe-8dce-0496-e063-6394a90add562025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.93e05175-001b-c639-e053-2a95a90a289c2025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Fungus FighterCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.9b4276af-b738-3293-e053-2a95a90ad0222025-08-19WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd617303f8-4463-4a1e-a502-44abc181d91f2025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Comb D Skin DisordersKALI MURIATICUM,KALI SULPHURICUM,CALCAREA SULPHURICA,SILICEAMartin & Pleasance Pty Ltd03153d92-dc68-4b84-a8c9-634b1ffd7da12025-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEAcuseplanet Inc3c04778b-9535-856e-e063-6294a90aa8682025-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Silica Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltdf70dcf90-bde9-404d-9ede-4113553ccbff2025-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.985a3341-0fe0-1dd6-e053-2a95a90ad2c52025-07-25WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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