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 3 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGLYCERIN LINGUALNITROGLYCERINAllegis Pharmaceuticals, LLCfadd07b7-189b-4678-ad0f-bf1e4d3d13002025-12-17Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Epl-Cell RepairCELL REPAIR AIDVitality Works, Inc.134d1cc1-2300-409d-b562-98ce807e77b32025-12-17WarningsExact identifier
unii: G59M7S0WS3
Migraine Headache TherapyATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -TRP Company317d3f42-783e-02b7-e054-00144ff88e882025-12-15WarningsExact identifier
unii: G59M7S0WS3
ViscumforcePASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AURUM METALLICUM, BARYTA CARBONICA, GLONOINUM, PHOSPHORUS, PLUMBUM METALLICUM, VISCUM ALBUMBioActive Nutritional, Inc.5848e409-f0b5-4323-ad00-8d058e85aaf42025-12-15WarningsExact identifier
unii: G59M7S0WS3
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: G59M7S0WS3
HeadacheELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.44ffb50a-7bfe-428b-e063-6394a90a9dcf2025-12-02WarningsExact identifier
unii: G59M7S0WS3
Headache-MigraineELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.45002cee-75e1-1d1a-e063-6294a90a6e0d2025-12-02WarningsExact identifier
unii: G59M7S0WS3
HeadacheELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.44ffafd7-8b43-5a24-e063-6294a90a80a32025-12-01WarningsExact identifier
unii: G59M7S0WS3
NITROSTATNITROGLYCERIN TABLETHenry Schein, Inc.5265648f-3062-48a2-a4e3-fea1207807a82025-11-06Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINHenry Schein, Inc.578d8159-5ec6-457f-b4a8-9add624d43a82025-11-06Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst422b4713-9531-f1bf-e063-6294a90ada2b2025-10-27Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINEncube Ethicals, Inc.7bcead76-a90f-4140-9c73-4339d981a0842025-09-26Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
nitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC3f7ebc5e-82a7-393d-e063-6394a90a173a2025-09-23Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINRedpharm Drug3dd022d8-c224-d19f-e063-6394a90adca42025-09-02Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINProPharma Distribution3d71f76d-bb22-7251-e063-6394a90aa9d82025-08-28Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
RAU VISCUMALLIUM SAT, CORIANDRUM SAT, CRATAEGUS OXY, GLONOINE, PASSIFLORA, ROWOLFIA, VISCUM ALBBM Private Limited3b3aafe4-7169-3b5f-e063-6394a90a9a6d2025-07-31WarningsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst9453bd8b-5d54-5dc8-e053-2995a90a95b22025-06-16Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Arterioforce IARNICA MONTANA, LILIUM TIGRINUM, AURUM MURIATICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, GLONOINUM, NUX VOMICA, VERATRUM ALBUMBioActive Nutritional, Inc.4f068076-413d-49e9-997c-57cfc22eb0802025-05-16WarningsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINSolco Healthcare U.S., LLC61759752-dd07-4bed-8079-b578e39305192025-04-30Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Arterioforce IARNICA MONTANA, LILIUM TIGRINUM, AURUM MURIATICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, GLONOINUM, NUX VOMICA, VERATRUM ALBUMBioActive Nutritional, Inc.e20fd8ba-738e-4160-bc15-49b9430e7a712025-04-16WarningsExact identifier
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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