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 20 of 33 · 659 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-117ATROPA BELLADONNA AND SILICON DIOXIDEDNA Labs, Inc.8bcce284-f8f3-4d62-a13e-b93c2c655a702025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-109ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLEDNA Labs, Inc.7758341d-e0be-487a-ba47-8847551231e12025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Incbe0da1f0-06a1-11df-8a39-0800200c9a662025-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
AM-9SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLEDNA Labs, Inc.d7a00f0b-de4c-4bff-b8e0-86a82bed8bb92025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-8SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARYDNA Labs, Inc.c25cdcb5-9469-48bb-b216-0a9d8d644e122025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-23ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.b6365b49-06fb-4692-96f7-a5097b70bc912025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-18OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, NITRIC ACID, AND SUS SCROFA PINEAL GLANDDNA Labs, Inc.3565c5d5-dc68-4f3f-99ec-30f8952393e02025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
NO-WEAK-NAILSGRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, AND SILICON DIOXIDEMiers Laboratories9158cd3f-4c27-40e9-bc07-fd560375c3a12025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Gout-GoneANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEASilver Star Brandsf66b42f0-8f5f-1aca-e053-2a95a90ae3962025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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