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 7 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HBPRUTA GRAVEOLENS, VALERIANA OFFICINALIS, ADRENALINUM, ARSENICUM IODATUM, AURUM METALLICUM, BARYTA CARBONICA, BRYONIA, CACTUS GRANDIFLORUS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, GLONOINUM, KALI CARBONICUM, KALI IODATUM, LACHESIS MUTUS, NAJA TRIPUDIANS, NUX VOMICA, VERATRUM ALBUM, VIPERA BERUS, VISCUM ALBUM, ELAPS CORALLINUS.Newton Laboratories, Inc.fb453b29-ffdf-bc31-e053-6394a90ab7f92023-05-09WarningsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINMedical Purchasing Solutions, LLf9b52553-5a26-d374-e053-6294a90a40c72023-04-19Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
GlonoinumNITROGLYCERINBoiron85a3f76b-7b09-5d00-e053-2a91aa0ad1de2023-02-20Exact identifier
unii: G59M7S0WS3
NitrostatNITROGLYCERINViatris Specialty LLC9a52da75-d0af-4237-96c0-0b12adfa86362023-02-15Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
GlonoinumNITROGLYCERINBoiron85a39643-ae56-f21e-e053-2991aa0a49152023-01-23Exact identifier
unii: G59M7S0WS3
GLAUTARAKTGOLD TRICHLORIDE, SOLANUM DULCAMARA TOP, EUPHRASIA STRICTA, NITROGLYCERIN, HEDERA HELIX FLOWERING TWIG, RUTA GRAVEOLENS FLOWERING TOP, TOBACCO LEAF, AND CYNARA SCOLYMUS WHOLEPEKANA Naturheilmittel GmbH0aac4f4f-8f71-44fa-906f-2bf35afea4312022-12-15WarningsExact identifier
unii: G59M7S0WS3
NITROGLYCERIN IN DEXTROSENITROGLYCERIN, DEXTROSEHF Acquisition Co LLC, DBA HealthFirst7b98d1fc-44b2-08a1-e053-2991aa0af3ab2022-12-09Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst7da79fdf-0969-1ddd-e053-2991aa0a3ec42022-12-09Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
1445184a-35fb-4ba3-bdb4-38a8c4fd1455e3da9f52-d094-49d2-90d8-994bd839a4a72022-10-20Warnings, Adverse reactionsExact identifier
spl id: 1445184a-35fb-4ba3-bdb4-38a8c4fd1455
spl set id: e3da9f52-d094-49d2-90d8-994bd839a4a7
GlonoinumGLONOINUMHahnemann Laboratories, INC.ea2975ae-687b-500b-e053-2a95a90a2e322022-10-03Exact identifier
unii: G59M7S0WS3
nitroglycerin lingualNITROGLYCERINPadagis Israel Pharmaceuticals Ltde7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d2022-09-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINProficient Rx LP67a15ee9-a6ae-4a60-8333-e06c608cfd712022-07-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Headek NasalBELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics976b9c85-68c9-46a5-9012-53cb24683b032021-12-29WarningsExact identifier
unii: G59M7S0WS3
OHM MenopauseAMMONIUM CARBONICUM, AMYL NITROSUM, CIMICIFUGA RACEMOSA, GLONOINUM, LACHESIS MUTUS, SANGUINARIA, CANADENSIS.OHM PHARMA INC.08dcc379-6d64-41b8-bf67-cab6031dcf722021-12-29WarningsExact identifier
unii: G59M7S0WS3
GLONOINUMGLONOINUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc6997b44a-4caf-4e2f-a930-50eb719453552021-10-11WarningsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINAmerican Regent, Inc.8c52cdf6-87be-4719-b105-f08be096d4622021-07-22Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
MenopauseELAPS CORALLINUS, AGNUS, ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CANTHARIS, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, CROTALUS HORRIDUS, DAMIANA, GLONOINUM, HELONIAS DIOICA, IGNATIA, KALI CARB., LACHESIS, NAJA, NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA, SANGUINARIA, SEPIA, ECHINACEA, VALERIANANewton Laboratories, Inc.995f6b76-b98e-0d32-e053-2995a90a14fe2020-12-04WarningsExact 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.994a037b-7165-3a1e-e053-2a95a90ad7ff2020-12-03WarningsExact identifier
unii: G59M7S0WS3
Dizzi-VABSINTHIUM, ACONITUM NAP., ANTIMON. TART., BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM, CONIUM, FERRUM METALLICUM, GELSEMIUM, GLONOINUM, HYOSCYAMUS, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, NUX VOM., PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER, ECHINACEA, HYPERICUM, PASSIFLORA, VALERIANANewton Laboratories, Inc.987fa8d3-2ac8-5771-e053-2995a90adc2f2020-12-02WarningsExact identifier
unii: G59M7S0WS3
Dizzi-VABSINTHIUM, ACONITUM NAP., ANTIMON. TART., BELLADONNA, BRYONIA, CARBOLICUM ACIDUM, COLCHICUM, CONIUM, FERRUM METALLICUM, GELSEMIUM, GLONOINUM, HYOSCYAMUS, IPECAC., IRIS VERSICOLOR, LYCOPODIUM, NUX VOM., PETROLEUM, PHOSPHORUS, SEPIA, SYMPHORICARPUS RACEMOSUS, TABACUM, THERIDION, ZINGIBER, ECHINACEA, HYPERICUM, PASSIFLORA, VALERIANANewton Laboratories, Inc.98f91b6f-2bb8-f7f9-e053-2a95a90a03612020-12-02WarningsExact identifier
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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