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 6 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1043debe-8787-a2f5-e063-6294a90a2a662024-01-31WarningsExact identifier
unii: G59M7S0WS3
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1045ab27-c4d5-fcbd-e063-6294a90a51762024-01-31WarningsExact identifier
unii: G59M7S0WS3
TinnitusACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.10462aaa-96d4-4ba3-e063-6294a90a79152024-01-31WarningsExact identifier
unii: G59M7S0WS3
Energy ComplexECHINACEA (ANGUSTIFOLIA), LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOX, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Health Masters LLC9286ca29-8190-4867-9231-b0d68180cb102024-01-22WarningsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINPrasco Laboratoriesf9731c86-34b0-42a2-8b39-eca907e02e742024-01-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINA-S Medication Solutionsfc297c0a-a412-40be-8414-4bf9906fd3002023-12-11Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
GlonoinumNITROGLYCERINBoiron85a1163a-fe45-e31a-e053-2991aa0a64662023-11-13Exact identifier
unii: G59M7S0WS3
GlonoinumNITROGLYCERINBoiron85a39d5c-2b11-62ed-e053-2a91aa0a0a312023-11-13Exact identifier
unii: G59M7S0WS3
GlonoinumNITROGLYCERINBoiron85a33a5a-41c6-3d84-e053-2a91aa0a6ec72023-11-13Exact identifier
unii: G59M7S0WS3
GlonoinumNITROGLYCERINBoiron7c0efc90-7a53-11e6-a302-424c583030312023-11-13Exact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINAurobindo Pharma Limited26c314ea-077e-490b-826b-2aafcb6e95642023-11-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
GlonoinumNITROGLYCERINBoiron85a47cfa-4d34-a596-e053-2a91aa0a02dc2023-10-30Exact identifier
unii: G59M7S0WS3
GlonoinumNITROGLYCERINBoiron85a3b808-b45a-f2f0-e053-2a91aa0af21f2023-10-23Exact identifier
unii: G59M7S0WS3
Hyten FormulaALLIUM SATIVUM, KIDNEY (BOVINE), LEONURUS CARDIACA, VISCUM ALBUM, AURUM METALLICUM, DIGITALIS PURPUREA, GLONOINUM, LYCOPODIUM CLAVATUM, RAUWOLFIA SERPENTINA, SULPHUR, PLUMBUM ACETICUM, BARYTA MURIATICANutritional Specialties, Inc.08b7b251-6048-42a6-bbed-9ed04624fee12023-09-28WarningsExact identifier
unii: G59M7S0WS3
CardCareECHINACEA, HYPERICUM, VALERIANA, ACONITUM NAP., ARSENICUM ALB., AUR. MET., BARYTA CARB., BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. FLUOR., CANTHARIS, CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, CONVALLARIA, CROTALUS HOR., DIGITALIS, GELSEMIUM, GLONOINUM, HYDROFLUORICUM AC. KALI IOD., LACHESIS, LYCOPUS, NAJA, NUX VOM., PHOS., PULSATILLA, RHUS TOX., VIPERA, ELAPS.Newton Laboratories, Inc.06342201-f0b4-de0d-e063-6294a90a56212023-09-25WarningsExact identifier
unii: G59M7S0WS3
Cyclease MenopauseARNICA MONTANA WHOLE, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOTBoirona227e8d8-27a3-592f-e053-2a95a90ab31c2023-08-16WarningsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINNatco Pharma USA LLC941ac242-120e-47c1-ac03-50026ff93dd62023-07-20Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC6671d89f-cc89-c03c-e053-2a91aa0aa5fa2023-06-05Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC8959095a-8cd8-f7d4-e053-2995a90a6e8f2023-05-31Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITRO-DURNITROGLYCERINIngenus Pharmaceuticals, LLC5e15296c-5acd-4bcc-80a8-b49cb1ef3eb02023-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 486146
rxcui: 486152
rxcui: 486148
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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