FDA.reportPublic FDA data

NDC 68382-310-01 - 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
68382-310
Requested NDC
68382-310-01
Package NDCs from labels
68382-310-01, 68382-310-30
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
68382-310-302024-01-30C16284748780-11030e365-569c-111a-e063-dadaa90a10e2Nitroglycerin Transdermal System Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-310-01Nitroglycerin Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE15
68382-310-01Nitroglycerin Transdermal System14 h in 1 PATCHPATCH, EXTENDED RELEASE145
68382-310-30Nitroglycerin Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-310NITROGLYCERIN 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
68382-310-01EA - Each68382-31073bdcece-2712-4435-b52b-e936e7675fb112017-03-06
68382-310-30EA - Each68382-3108e96931b-2f88-4532-8118-277622f711c812017-03-06

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 8 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Hands - FeetHISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEANewton Laboratories, Inc.7a2b4f28-2128-a8b2-e053-2a91aa0a24022020-11-24WarningsExact identifier
unii: G59M7S0WS3
ArtalgiaCARDUUS MARIANUS, ARNICA MONTANA, AGARICUS MUSCARIUS, BARYTA CARBONICA, BELLIS PERENNIS, GLONOINUM, HAMAMELIS VIRGINIANA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SECALE CORNUTUM, VANADIUM METALLICUM, CARBO VEGETABILIS, HYPERICUM PERFORATUM, PHOSPHORUS PULSATILLA (PRATENSIS), RHUS TOXTodd Horton DPM9404b908-5b1c-44b0-a9ff-35f3768b8ed72020-07-15WarningsExact identifier
unii: G59M7S0WS3
Nitroglycerin Transdermal Infusion SystemNITROGLYCERINDr. Reddy's Laboratories, Inc.4f85d2e0-2e37-fcd1-276d-5a64665542892020-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 486146
rxcui: 486152
rxcui: 486148
unii: G59M7S0WS3
NitrostatNITROGLYCERINProficient Rx LP6fe3965f-0dd8-4bae-9771-de25074cb1b02019-11-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: G59M7S0WS3
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: G59M7S0WS3
Nitroglycerin In DextroseNITROGLYCERINBaxter Healthcare Company457a026c-ebce-4701-9deb-2d7652759a992016-08-22Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINMylan Pharmaceuticals Inc.e98a2692-1cb9-4994-98d8-1d8d9ef1a2562014-11-03Warnings, 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.