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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0258-3613-01	Isorbide Dinitrate	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1
0258-3613-10	Isorbide Dinitrate	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0258-3613	ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1	2 package rows	20070726_11fa7725-cb19-46f6-9468-01a0a430492c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Isosorbide dinitrate	ACTIVE INGREDIENT	IA7306519N	ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
ISOSORBIDE	ACTIVE MOIETY	WXR179L51S	ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
Isosorbide dinitrate	ACTIVE MOIETY	IA7306519N	ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1
anhydrous lactose	INACTIVE INGREDIENT		ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
colloidal silicon dioxide	INACTIVE INGREDIENT		ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
FD&C Yellow #6 Aluminum Lake	INACTIVE INGREDIENT		ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
hydroxypropyl methylcellulose	INACTIVE INGREDIENT		ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	ISORBIDE DINITRATE (ISORBIDE DINITRATE) TABLET, EXTENDED RELEASE [INWOOD LABORATORIES, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ISOSORBIDE 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 22 of 33 · 659 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Scrophulous HP	BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, GNAPHALIUM POLYCEPHALUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEA	Energique, Inc.	e50eb26b-6843-4b8f-8ea5-3d5f57a3e7b4	2024-10-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Chavita 1	CARBO VEG, OOPHORINUM, SILICEA, OLIBANUM, ORCHITINUM, URTICA URENS	RUBIMED AG	0ade088f-0ff2-4894-9aed-d0b0cfdde38d	2024-10-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Pulmopar	LOBELIA INFLATA, LUNG (SUIS), SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, BLATTA ORIENTALIS, BRYONIA (ALBA), PHOSPHORUS, SILICEA, SULPHUR	Energique, Inc.	1cfb69c5-dc01-4acc-8053-5ca4e64165dc	2024-10-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Multi-Cell Salt	KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CALCAREA SULPHURICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, SILICEA	Energique, Inc.	dad00225-b3ac-4e36-a856-19b0faf42c42	2024-10-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Otoflam HP	BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.	Energique, Inc.	76c6b494-43d1-4508-bea4-4f9026b4a5fa	2024-10-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea 30X	SILICON DIOXIDE	True Botanica, LLC	1d99c26a-3f95-c138-e063-6294a90a9d62	2024-10-28	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lymphastat	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUM	Energique, Inc.	ed3e0362-a4d3-46fa-a045-17bf659b777c	2024-10-28	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hypothalmupar	ARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEA	Energique, Inc.	8b01e718-83b7-4f93-8fea-d0e37c756185	2024-10-28	Warnings	Exact identifier unii: ETJ7Z6XBU4
FATIGUE NOSODE EB	ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARANEA DIADEMA, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, SEPIA, EPSTEIN-BARR VIRUS NOSODE	Energique, Inc.	36d963cc-fd47-40ee-aa73-c2e7fcedf192	2024-10-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Complexion HP	CARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUM	Energique, Inc.	ad12d51e-04cb-4833-b802-0038796966ff	2024-10-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Bryant Ranch Prepack	73a1e6c0-71d0-4ba1-bbca-c067479e487d	2024-10-08	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
Granite 30X	GRANITE 30X	True Botanica, LLC	21b2bae6-8176-ccbf-e063-6394a90a97b5	2024-10-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
EMF Protect and Balance	ALFALFA, CADMIUM SULPHURATUM, CALCAREA CARBONICA, CUPRUM METALLICUM, FERRUM METALLICUM, FUCUS VESICULOSUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, SILICEA, SYMPHYTUM OFFICINALE, TARENTULA CUBENSIS, X-RAY, YTTERBIUM OXIDE	Deseret Biologicals, Inc.	9ea8dfe3-7d95-4b86-8e1f-dc9e414e854a	2024-10-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydration Complex	BOLDO, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, HYPERICUM PERFORATUM, GINKGO BILOBA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, GERMANIUM SESQUIOXIDE, SILICEA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA	Deseret Biologicals, Inc.	891265ff-2651-4d84-a77b-331e3eb7e3ec	2024-10-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Bone Support HP	CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPATORIUM PERFOLIATUM, HEKLA LAVA, HYDROFLUORICUM ACIDUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, STRONTIUM CARBONICUM, SYMPHYTUM OFFICINALE	Energique, Inc.	da6937b9-da23-4e78-96af-2ca40f973a02	2024-09-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Advanced Eye Relief/ Redness Maximum Relief	NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE	Bausch & Lomb Incorporated	3c11285a-7e86-4b47-b1ee-e7d59858087d	2024-09-25	Warnings	Exact identifier unii: 3NXW29V3WO
Lymphapar	ECHINACEA (ANGUSTIFOLIA), LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM , KALI MURIATICUM, LACHESIS MUTUS, SILICEA	Energique, Inc.	c746c111-7ebc-46c1-b11b-04271887df9c	2024-09-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
HP Axis	ARGENTUM NITRICUM, BERBERIS VULGARIS, IODIUM, KALI CARBONICUM, NATRUM MURIATICUM, ADRENALINUM, CORTISONE ACETICUM, DHEA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, MELATONIN, TESTOSTERONE, ARSENICUM ALBUM, PHOSPHORUS, PROTEUS (VULGARIS), SEPIA, SILICEA, ALLOXANUM, CORTICOTROPIN RELEASING HORMONE, ADRENOCORTICOTROPHIN, ALDOSTERONE	Deseret Biologicals, Inc.	402f5b05-c71e-4dba-bc2b-049aee42952a	2024-09-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
Isosorbide dinitrate	ISOSORBIDE DINITRATE	BluePoint Laboratories	f1d52e9a-8de1-61db-e053-2a95a90aae50	2024-09-17	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
Chronagesic	ARNICA MONTANA, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, SANGUINARIA CANADENSIS, SULPHUR, PIPER NIGRUM, ALPHA-LIPOICUM ACIDUM, CARTILAGO SUIS, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS, APIOLUM	Deseret Biologicals, Inc.	66e351ed-d359-4367-a950-fc57b37489ab	2024-09-11	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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