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 1 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC.5b150cd2-fac8-86ce-e063-6294a90a67b92026-09-09Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
RectivNITROGLYCERINAllergan, Inc.603aa9ed-54c4-4a35-ade4-690fa44850e42026-09-08Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
nitroglycerinNITROGLYCERINREMEDYREPACK INC.89da40c1-bab1-422e-b326-8ebcbdbc81f32026-09-03Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINREMEDYREPACK INC.b8af0974-33ea-4dd5-9ff7-3b61272aeb252026-09-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst9a539019-5f43-1448-e053-2a95a90a3bca2026-08-25Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
nitroglycerinNITROGLYCERINRedpharm Drug594b939f-d399-835e-e063-6294a90a44222026-08-18Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINREMEDYREPACK INC.486f53ce-e3c6-48b0-a6ef-9d08cde387e32026-08-10Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINPadagis Israel Pharmaceuticals Ltd562d2e03-dfed-41ff-8e7f-ec41691419832026-07-06Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: G59M7S0WS3
BM BM116 DROPSADONIS VER, ALLIUM SATIVA, CRATAEGUS OXY, GLONOINUM, PASSIFLORA, VERATRUM VIRIDE, VISCUM ALBUMBM Private Limited540c3c0b-7746-78ae-e063-6394a90a5e2a2026-06-12WarningsExact identifier
unii: G59M7S0WS3
BM BM116 DROPSADONIS VER, ALLIUM SATIVA, CRATAEGUS OXY, GLONOINUM, PASSIFLORA, VERATRUM VIRIDE, VISCUM ALBUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5417e269-87c9-5802-e063-6294a90a8c3e2026-06-12WarningsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINEncube Ethicals, Inc.c17c997b-0e90-4105-888b-2de22d2bf6972026-05-28Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITRO-TIMENITROGLYCERINTIME CAP LABORATORIES, INC3c11c1c2-8e62-4f63-8293-2f8b8d845f7e2026-05-18Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINBryant Ranch Prepack7cf08521-aaf6-4129-9f8e-077d6282fbc62026-05-18Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: G59M7S0WS3
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINSportpharm LLC84739085-81df-4a43-8456-c9edfbf971e92026-04-24Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC4e83a438-1ed6-0a86-e063-6294a90adc8c2026-04-02Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst4b4667e9-3b5e-4dc0-e063-6394a90ac1f52026-03-20Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Headache and Migraine ReliefBELLADONNA, BRYONIA, CAPSICUM ANNUUM, GELSEMIUM, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM, NATRUM MURIATICUM, NICCOLUM METALLICUM, NUX VOMICA, SANGUINARIA, SECALE CORNUTUM, SPIGELIA ANTH AND SULPHUR.King Bio Inc.efbfd58c-f3a6-4734-a37f-9f58fded990a2026-03-06WarningsExact identifier
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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