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 5 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGLYCERINNITROGLYCERINTrupharma, LLC543ef8c8-d520-461b-bf6e-f8d8c277feec2024-12-03Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Pericardium Triple Warmer Meridian OpenerARSENICUM ALBUM, AURUM METALLICUM, BARYTA CARBONICA, CALCAREA CARBONICA, GLONOINUM, IODIUM, KALI IODATUM, LACHESIS MUTUS, LITHIUM CARBONICUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA, SPONGIA TOSTA, TABACUM, THYROIDINUM (SUIS)Deseret Biologicals, Inc.060ecfed-5d31-49ca-82d8-9b05355da59d2024-10-22WarningsExact 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.0bb404b6-a7c1-4077-995e-d7ce59409a292024-10-17WarningsExact identifier
unii: G59M7S0WS3
Headache TonicCARDUUS MARIANUS, PYRETHRUM PARTHENIUM, SECALE CORNUTUM, ACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SEPIA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.a6526cc4-028b-45df-ac1f-c3cec7556e932024-10-17WarningsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINMylan Pharmaceuticals Inc.041f127e-5166-4484-bc1a-0a373d1187ae2024-10-15Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROSTATNITROGLYCERINA-S Medication Solutionsf7059ff7-bf74-48b4-811d-6eb1c26bfd8b2024-08-05Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINNuCare Pharmaceuticals,Inc.f4ea9ad1-a71f-7cea-e053-2a95a90a106d2024-07-22Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
ArteriotoneBAPTISIA TINCTORIA, CACTUS GRANDIFLORUS, ECHINACEA (ANGUSTIFOLIA), ADONIS VERNALIS, AGNUS CASTUS, ARNICA MONTANA, AURUM METALLICUM, DIGITALIS PURPUREA, GLONOINUM, VANADIUM METALLICUMEnergique, Inc.4bb46cf1-bfcb-4d57-a982-7ba87e2b299a2024-07-16WarningsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINProficient Rx LP41fe1f25-bfd0-4eaf-973d-bdb6b5d70f932024-07-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
GLONOINUMGLONOINUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc19ce76ed-ce59-1214-e063-6394a90a6b772024-06-01WarningsExact identifier
unii: G59M7S0WS3
NITROLINGUALNITROGLYCERININDEPENDENCE PHARMACEUTICALS, LLCd19b5f51-ca85-48d6-9ccd-8ae26249cdc32024-05-13Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
BP RegADRENALINUM, ALLIUM SATIVUM, ALPHA-LIPOICUM ACIDUM, ARTERIA SUIS, AURUM METALLICUM, CACTUS GRANDIFLORUS, CHOLESTERINUM, CORTISONE ACETICUM, COUMARINUM, FORMALINUM, GLONOINUM, KALI CHLORICUM, LACHESIS MUTUS, PROTEUS (VULGARIS), RAUWOLFIA SERPENTINA, STRONTIUM CARBONICUM, SULPHUR, THYROIDINUM (SUIS), VENA SUIS, VERATRUM ALBUMDeseret Biologicals, Inc.540c1149-b6d4-4926-87e8-73a920f87b4a2024-05-09WarningsExact identifier
unii: G59M7S0WS3
BP RegALLIUM SATIVUM, ADRENALINUM, ARTERIA SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), VENA SUIS, FORMALINUM, KALI CHLORICUM, ALPHA-LIPOICUM ACIDUM, AURUM METALLICUM, CACTUS GRANDIFLORUS, CHOLESTERINUM, COUMARINUM, EPHEDRA VULGARIS, GLONOINUM, LACHESIS MUTUS, RAUWOLFIA SERPENTINA, STRONTIUM CARBONICUM, SULPHUR, VERATRUM ALBUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.f99833d8-d637-4c63-afe8-25eb2f05de6a2024-05-08WarningsExact identifier
unii: G59M7S0WS3
CirculationCACTUS GRANDIFLORUS, KALI CARBONICUM, KALMIA LATIFOLIA, ARNICA MONTANA, GLONOINUM, IGNATIA AMARA, LACTICUM ACIDUM, RANUNCULUS BULBOSUS, ALPHA-KETOGLUTARICUM ACIDUM, ARSENICUM ALBUM, FUMARICUM ACIDUM, HEART (SUIS), HEPAR SUIS, MALICUM ACIDUM, NATRUM OXALACETICUM, PHOSPHORUS, STROPHANTHUS HISPIDUS, SPIGELIA ANTHELMIA, CARBO VEGETABILIS, NAJA TRIPUDIANS, CYTOMEGALOVIRUS NOSODE, EPSTEIN-BARR VIRUS NOSODEDeseret Biologicals, Inc.29f30a6a-406d-4fb4-850d-d33486fbafe42024-04-18WarningsExact identifier
unii: G59M7S0WS3
VascuflowMELATONIN, L-ARGININE, L-CITRULLINE, UBIDECARENONUM, SQUALENE, CALCAREA CARBONICA, CHOLESTERINUM, COUMARINUM, FORMALINUM, GELSEMIUM SEMPERVIRENS, ALPHA-LIPOICUM ACIDUM, MERCURIUS CORROSIVUS, PLUMBUM METALLICUM, PANTOTHENIC ACID, GLONOINUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, BERBERIS VULGARIS, RED YEAST RICE, NITRIC OXIDE, PROTEUS (MORGANI), RHUS TOXDeseret Biologicals, Inc.1ca5d57d-7cf0-4b9a-afa0-767dca99864d2024-04-02WarningsExact identifier
unii: G59M7S0WS3
Heart/FatigueKALI CARBONICUM, ARNICA MONTANA, CACTUS GRANDIFLORUS, CASTOREUM, RANUNCULUS BULBOSUS, GELSEMIUM SEMPERVIRENS, GLONOINUM, HEART (SUIS), SPIGELIA ANTHELMIA, ABROTANUM, SULPHURDeseret Biologicals, Inc.560c2269-2cc8-489e-8487-9661ff7017d82024-03-27WarningsExact identifier
unii: G59M7S0WS3
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: G59M7S0WS3
NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirsta8eb91f6-7f2e-7d57-e053-2995a90a38932024-02-22Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINCosette Pharmaceuticals, Inc.ac908e70-9425-4e9c-8c67-7b2882b402042024-02-21Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINProficient Rx LP160b85ac-d964-463b-9f1e-1429f14ed3182024-02-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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