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 25 of 33 · 659 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ver	ARTEMISIA VULGARIS, ASCARIS LUMBRICOIDES, BRUGIA MALAYI, CALCAREA CARBONICA, CINA, CRYPTOSPORIDIUM PARVUM, ENTEROBIUS VERMICULARIS, FILIX MAS, GIARDIA LAMBLIA, GRAPHITES, IODIUM, MERCURIUS CORROSIVUS, QUASSIA (AMARA), SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TAENIA SAGINATA, TAENIA SOLIUM, TEUCRIUM MARUM, THYMUS SERPYLLUM, TRICHINELLA SPIRALIS, TRICHOMONAS VAGINALIS	Deseret Biologicals, Inc.	b47bdd57-14cd-46e9-a34e-0d8a7c21bda2	2024-03-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Elevate	LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)	Deseret Biologicals, Inc.	5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b	2024-03-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Spinalmax	BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM	Deseret Biologicals, Inc.	6c569331-2167-44bb-ace6-13340e7d8d6a	2024-03-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Perfect Sleep	ADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUM	Deseret Biologicals, Inc.	81f29472-a2e6-486d-aefd-17135ad410ef	2024-03-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Kidney Drainage	SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM	Deseret Biologicals, Inc.	a030afc6-9248-4e6a-a814-bd700c053e5c	2024-02-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Cough	IPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXIN	Deseret Biologicals, Inc.	4a8deb4a-9f26-46a9-8d99-99df36407f22	2024-02-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Perfect Sleep	ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)	Deseret Biologicals, Inc.	6d934960-63c6-4536-bde3-38c26f8083dc	2024-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Sandoz Inc.	71fdd147-a987-40b6-9f07-82d56525ceb8	2024-02-01	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
Silicea	SILICON DIOXIDE	SEVENE USA	0805d866-ce1a-4f54-8a44-83d4902e8c0d	2024-01-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
GENTEAL TEARS	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	A-S Medication Solutions	a2b715e9-332d-4f0b-b8e5-ebc000681586	2024-01-21	Warnings	Exact identifier unii: 3NXW29V3WO
Sleep Tight	ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)	Dr. Donna Restivo DC	b5955fbc-71f8-4fe0-9df0-42f337ab9c7d	2024-01-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
A05 HEAVY ANTITOX	ALLIUM CEPA, ALLIUM SATIVUM, ALUMINIUM METALLICUM, APIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, BELLADONNA, BERBERIS VULGARIS, CADMIUM METALLICUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, FAGUS SYLVATICA, FORMALINUM, FORMICUM ACIDUM, HYPERICUM PERFORATUM, ICHTHYOLUM, MERCURIUS CORROSIVUS, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PLUMBUM METALLICUM, SELENIUM METALLICUM, SILICEA, SOLIDAGO VIRGAUREA, STANNUM METALLICUM, THIOSINAMINUM	Apex Energetics Inc.	b9bdc39e-8ebf-615c-e053-2a95a90afe1b	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
C08 CALCIUM METABOLISM	ABIES ALBA LEAFY TWIG, CALCAREA ACETICA, CALCAREA ARSENICICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA HYPOPHOSPHOROSA, CALCAREA IODATA, CALCAREA MURIATICA, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CALCAREA PICRATA, CALCAREA SULPHURICA, CALCULUS BOVIS, CALENDULA OFFICINALIS, CHOLESTERINUM, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, LAPIS ALBUS, SILICEA, SULPHUR IODATUM, SUS SCROFA PARATHYROID GLAND, SYMPHYTUM OFFICINALE, URTICA URENS, VITAMIN D	Apex Energetics Inc.	bd09a34f-1615-09f0-e053-2995a90ac2ef	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
F10 WRMLV	AGRIMONY, ALOE VERA, AURUM METALLICUM, AZURITE, BASIL, CALENDULA OFFICINALIS, CARICA PAPAYA, CAYENNE, DAFFODIL, DICENTRA FORMOSA, DIPLACUS AURANTIACUS, HIBISCUS CHINENSIS, HORSE CHESTNUT, HYLOTELEPHIUM TELEPHIUM, LAVANDULA STOECHAS, LILIUM TIGRINUM, MALVA NEGLECTA, MELILOTUS ALBA, NELUMBO NUCIFERA, PHOSPHORUS, PRUNELLA VULGARIS, ROSA LUCIAE, ROSEMARY, SCUTELLARIA LATERIFLORA, SEPIA, SILICEA, THUJA OCCIDENTALIS, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, YELLOW JASMINE	Apex Energetics Inc.	bf020c17-578d-74c4-e053-2995a90a9e7d	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
F09 LTGO	ADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALIS	Apex Energetics Inc.	bd1e652f-b3a4-c5bd-e053-2995a90ae03f	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
N01 PROTOMER	ADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUM	Apex Energetics Inc.	bfc8e049-2f62-31c4-e053-2a95a90a6e16	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
F25 LF-CHNGS	AGRIMONY FLOWER	Apex Energetics Inc.	bf3c7a21-0e4e-6395-e053-2a95a90a7156	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
R16 BRONCHI	ADENOSINE TRIPHOSPHATE, CALCAREA IODATA, CUPRUM METALLICUM, IGNATIA AMARA, PLATINUM METALLICUM, SILICEA, THUJA OCCIDENTALIS	Apex Energetics Inc.	c0f759b1-d7f8-12b3-e053-2a95a90a8768	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
N09 BACTEROTOX	ACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALIS	Apex Energetics Inc.	ba99bb1e-c36f-8bf8-e053-2995a90ac308	2024-01-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
DV HP	CALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEA	BioActive Nutritional, Inc.	74bda12d-5e3d-4f52-9e3f-98012c92fc91	2024-01-05	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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