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 29 of 33 · 659 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gyno Complex	VIBURNUM OPULUS, MAGNESIA PHOSPHORICA, FOLLICULINUM, PULSATILLA (PRATENSIS), BORAX, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALIS	Deseret Biologicals, Inc	dfaaa56a-4226-4f62-a219-d3f89fe7afe3	2023-01-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICON DIOXIDE	Boiron	86d367e5-e846-54ba-e053-2991aa0a63d4	2023-01-12		Exact identifier unii: ETJ7Z6XBU4
Perfect Sleep	ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS	Deseret Biologicals, Inc.	f267fff4-f331-49b8-bd48-7d383da52246	2023-01-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
DALEKTRO N	SILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COBALTOUS NITRATE HEXAHYDRATE, CUPRIC ACETATE, IRON, POTASSIUM CARBONATE, MAGNESIUM CHLORIDE, MANGANESE ACETATE TETRAHYDRATE, SELENIUM, SILICON DIOXIDE, AND ZINC PHOSPHIDE	PEKANA Natruheilmittel GmbH	2b39ce30-54ff-4586-bda1-d9410140b26e	2023-01-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rehydrate	AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN	ParaDocs All Natural, Inc.	648fab10-c46b-420f-a42c-6642009d83fb	2023-01-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
SUPREN	ARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDE	PEKANA Naturheilmittel GmbH	3b34740c-b181-4f05-9858-15b7211a4c67	2022-12-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
KELAN	SILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOP	PEKANA Naturheilmittel GmbH	55786d99-ee1f-490f-9023-3e6c39da86b0	2022-12-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
COLIC CP	AETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR.	Natural Creations, Inc.	7c2a2f6e-a332-4c68-a7a8-fdc390f1827e	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Warts	ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM	Newton Laboratories, Inc.	f0315c9e-8922-c0b5-e053-2a95a90ae54e	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Warts	ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM	Newton Laboratories, Inc.	f031e256-fca5-3939-e053-2995a90a4fe6	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
SILICEA	SILICON DIOXIDE	Hyland's Inc.	86da31ff-b39a-4ac2-92e5-810f6d8888e6	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Warts	ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM	Newton Laboratories, Inc.	f0328097-e5d2-3532-e053-2a95a90a93f0	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Warts	ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM	Newton Laboratories, Inc.	f032e7bb-a6fd-2951-e053-2a95a90a8c3a	2022-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Cataracc	ARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET.	Newton Laboratories, Inc.	eff981fd-5436-7c34-e053-2a95a90a3e8e	2022-12-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICON DIOXIDE	Hyland's Inc.	d3c426ab-1a61-3494-e053-2a95a90a9677	2022-12-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Silicea	SILICEA	Hahnemann Laboratories, INC.	efcdc393-5dab-38d1-e053-2995a90acb2e	2022-12-14		Exact identifier unii: ETJ7Z6XBU4
Defend Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	bb851be1-0528-4199-91e7-e09f994b2862	2022-12-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA	OHM PHARMA INC.	044a7174-f7a3-490f-9cad-01f2665d7575	2022-12-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
4 Kids Cold and Mucus Nighttime	EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR	Hyland's Inc.	6f7b2585-2f0e-5938-e053-2a91aa0aa9d1	2022-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
4 Kids Complete Cold and Mucus	BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE	Hyland's Inc.	ef39fe3d-a42d-4baa-9199-91f664feb432	2022-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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