FDA.reportPublic FDA data

NDC 68382-309-01 - Nitroglycerin Transdermal System

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
68382-309
Requested NDC
68382-309-01
Package NDCs from labels
68382-309-01, 68382-309-30
Manufacturer
Zydus Pharmaceuticals USA Inc.
Effective date
2022-10-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nitroglycerin Transdermal System - Zydus Pharmaceuticals USA Inc.Zydus Pharmaceuticals USA Inc.2022-10-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68382-309-302024-01-30C16284748780-11030e365-569c-111a-e063-dadaa90a10e2Nitroglycerin Transdermal System Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-309-01Nitroglycerin Transdermal System14 h in 1 PATCHPATCH, EXTENDED RELEASE145
68382-309-01Nitroglycerin Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE15
68382-309-30Nitroglycerin Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-309NITROGLYCERIN TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]5Legacy NDC, 3 package rows20221021_e3da9f52-d094-49d2-90d8-994bd839a4a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-309-01EA - Each68382-30936d7eb92-6fc8-4635-9f68-1d9deb73e94012017-03-06
68382-309-30EA - Each68382-3095c98c65f-f7a0-49c1-9d61-f1696441359b12017-03-06

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 4 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM179ACONITE, CACTUS GRAND, CRATAEGUS OXY, DIGITALIS PUR, GLONOINE, MAG PHOS, SPIGELIA, STROPHANTHUSBestmade Natural Products2e818a28-a5cc-5c98-e063-6294a90a51f32025-02-19WarningsExact identifier
unii: G59M7S0WS3
VitalityECHINACEA, LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM, GLYCYRRHIZA GLABRANewton Laboratories, Inc.9d3a6b0e-a23f-9f2d-e053-2995a90a75cf2025-02-10WarningsExact identifier
unii: G59M7S0WS3
Bestmade Natural Products BM116ANGUILLARE ICHTHY, CRATAEGUS OXY, PASSIFLORA, HYPOPHYSIS POSTERIUM, GLONINE, MORGAN PURE, SPARTIUM SCOP, VISCUM ALBUMBestmade Natural Products2d8fcde8-d876-d028-e063-6294a90a5e7b2025-02-07WarningsExact identifier
unii: G59M7S0WS3
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4872fd-bfe5-2472-e053-2995a90a361f2025-02-07WarningsExact identifier
unii: G59M7S0WS3
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.9c4718ef-86ac-7bb7-e053-2a95a90a56272025-02-07WarningsExact identifier
unii: G59M7S0WS3
Motion SicknessECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ABSINTHIUM, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, GLONOINUM, HYOSCYAMUS NIGER, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c5a4018-0231-e92b-e053-2995a90a40162025-02-07WarningsExact identifier
unii: G59M7S0WS3
Motion SicknessECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ABSINTHIUM, ACONITUM NAPELLUS, ANTIMONIUM TARTARICUM, BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM AUTUMNALE, CONIUM MACULATUM, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, GLONOINUM, HYOSCYAMUS NIGER, IPECACUANHA, IRIS VERSICOLOR, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c592084-9412-c00b-e053-2a95a90a57902025-02-07WarningsExact identifier
unii: G59M7S0WS3
Hangover HelpAGARICUS MUSC., ARSENICUM ALB., BISMUTHUM METALLICUM, BRYONIA, CAPSICUM, CARBO VEG., GLONOINUM, IPECAC., IRIS VERSICOLOR, LAUROCERASUS, LYCOPODIUM, MEZEREUM, NUX VOM., PULSATILLA, RANUNC. BULB. , THERIDION, VERATRUM ALB., ZINC. MET., ZINGIBER, CHAMOMILLA, PASSIFLORA, VALERIANANewton Laboratories, Inc.9bcce2ee-42c2-29cf-e053-2a95a90a36392025-02-06WarningsExact identifier
unii: G59M7S0WS3
nitroglycerinNITROGLYCERINNorthStar RxLLC141b6098-dd8e-4c99-a581-197d46f9e0b12025-01-17Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINNuCare Pharmaceuticals, Inc.2bad7976-4eb0-d064-e063-6394a90a75de2025-01-14Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
D-12POTASSIUM IODIDE, CALCIUM IODIDE, ARSENIC TRIIODIDE, BARIUM CHLORIDE DIHYDRATE, NITROGLYCERIN, CONIUM MACULATUM FLOWERING TOP, ARNICA MONTANA, PHOSPHORUS, AND GOLD TRICHLORIDEDNA Labs, Inc.cd69e429-32af-4d77-9ec1-c40cfc7fe4142025-01-13WarningsExact identifier
unii: G59M7S0WS3
D-47FERULA ASSA-FOETIDA RESIN, ARABICA COFFEE BEAN, NITROGLYCERIN, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, AND ANEMONE PRATENSISDNA Labs, Inc.43bc349f-016d-41c8-88db-2e42abdf63ba2025-01-13WarningsExact identifier
unii: G59M7S0WS3
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: G59M7S0WS3
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: G59M7S0WS3
NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirst947e4e68-ef8a-6c63-e053-2a95a90ac1932025-01-08Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirst9483ea48-0b1e-68c0-e053-2995a90a84d52025-01-08Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstc20e89b4-57b5-259d-e053-2a95a90a00382025-01-08Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Cardioforce IARNICA MONTANA, CACTUS GRANDIFLORUS, CAPSICUM ANNUUM, DIGITALIS PURPUREA, KALI PHOSPHORICUM, LAUROCERASUS, SPIGELIA ANTHELMIA, TABACUM, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, AURUM MURIATICUM, GLONOINUM, IGNATIA AMARA, KALMIA LATIFOLIA, LATRODECTUS MACTANS, VALERIANA OFFICINALISBioActive Nutritional, Inc.506c0d88-d888-4f7a-b8de-cb00482c25372025-01-02WarningsExact identifier
unii: G59M7S0WS3
Migraine EaseBELLADONNA, BRYONIA, CIMICIFUGA, GELSEMIUM, GLONOINUM, IGNATIA, IRIS VERS, NUX VOM, SANGUINARIA, SEPIA, SPIGELIA ANTHSilver Star Brandsc68ab321-7105-0e54-e053-2995a90a298a2025-01-01WarningsExact identifier
unii: G59M7S0WS3
nitroglycerinNITROGLYCERINLifestar Pharma LLC38059df3-be1b-4226-9f12-c3c37cb44fea2024-12-30Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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