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 30 of 33 · 659 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hendel Periodontal and Tooth Pain Relief	SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE	MediNatura Inc	f34e9f77-69fd-4c7f-9eea-2d721a4d27fb	2022-08-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
isosorbide dinitrate and hydralazine hydrochloride	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Wilshire Pharmaceuticals	620a0680-aad0-4923-84be-7393c0cbdcbd	2022-04-14	Warnings, Adverse reactions	Exact identifier unii: IA7306519N
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe Mexico, S.A. de C.V.	3e2e5f52-db54-4635-83a8-a67a683c093c	2022-03-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
ALPHA SH	SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS	Schwabe North America, Inc.	94de9ce3-6ee9-4322-bda2-0b4391f09d87	2022-03-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da807eb3-34a3-61b9-e053-2995a90a0e21	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da80a5ea-f603-719e-e053-2995a90a9710	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da81b21a-090a-dabf-e053-2995a90aa05e	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	da821d05-b2f0-3582-e053-2a95a90afe59	2022-03-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Care	ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM	Newton Laboratories, Inc.	da717cf0-54af-c4e2-e053-2995a90ac97c	2022-03-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
EAR RX	ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM	Miami Beach Pediatrics pa	a8753f88-4b8a-472f-a4bd-f2e9cec83610	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lyme Disease Support 2	ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA.	OHM PHARMA INC.	13b4b78b-f9f7-4cf6-8f43-61679160086b	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Lyme Disease Support 1	ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA.	OHM PHARMA INC.	035e75d6-aeef-4dfd-b076-9d3d8e4a5086	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
OHM Skin Healing Cream	CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.	OHM PHARMA INC.	c12e6706-37f0-4900-856c-fc7e7ac3b724	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
OHM Skin Healing Gel	CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA.	OHM PHARMA INC.	f97dffe6-cddc-4577-afcc-deadb7abd0c6	2021-12-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM	Energetix	75826e2a-737a-43ac-aed7-fad960889b88	2021-12-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
HAIR STIM	PEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINOR	The Wellness Center for Research and Education, Inc.	d5c75dc2-9edc-429e-8f25-e5641fe5042f	2021-11-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
CONSTIPATION CP	ALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.	Natural Creations, Inc.	961b3ddf-41fe-46ed-b5e4-0fd8d9652edf	2021-11-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
CENTROCODE	AMERICAN GINSENG, ADENOSINE TRIPHOSPHATE, CORTICOTROPIN, ALFALFA, BOS TAURUS HYPOTHALAMUS, PHYTOLACCA AMERICANA ROOT, BOS TAURUS PITUITARY GLAND POSTERIOR, THYROID UNSPECIFIED, IODINE, SILICON DIOXIDE, OSTER SHELL CALCIUM CARBONATE CRUDE, STRYCHNOS IGNATII SEED, IRIDIUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SELENIUM, URANYL NITRATE HEXAHYDRATE.	Natural Creations, Inc.	e5bbe9ec-7602-4de5-907a-7047c10198b6	2021-11-15	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hydrate 2	BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA	Natural Creations, Inc	52cb98dc-6858-42bf-9c54-d20fb607dfbb	2021-11-12	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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