FDA.reportPublic FDA data

NDC 68071-4834-01 - Ondansetron

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
68071-4834
Requested NDC
68071-4834-01
Package NDCs from labels
68071-4834-1, 68071-4834-4, 68071-4834-2, 68071-4834-6, 68071-4834-7, 68071-4834-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4834-12021-02-17C16284748780-1ba0f9c33-1093-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
68071-4834-12021-01-29C16284748780-1ba0f9c33-1093-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4834-1Ondansetron10 in 1 BOXTABLET, ORALLY DISINTEGRATING108
68071-4834-2Ondansetron2 in 1 BOXTABLET, ORALLY DISINTEGRATING28
68071-4834-4Ondansetron4 in 1 BOXTABLET, ORALLY DISINTEGRATING48
68071-4834-6Ondansetron6 in 1 BOXTABLET, ORALLY DISINTEGRATING68
68071-4834-7Ondansetron20 in 1 BOXTABLET, ORALLY DISINTEGRATING208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4834ONDANSETRON TABLET, ORALLY DISINTEGRATING [NUCARE PHARMACEUTICALS,INC.]8Current NDC, Legacy NDC, 5 package rows20240616_85cd0c27-788d-5fd8-e053-2a91aa0a7c69.zip

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 24 of 34 · 672 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f9df74a8-f225-44ca-91ba-dca4f3f35da02024-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONBryant Ranch Prepackd9321ef6-9fe5-4631-9c58-534fd963cf172024-08-08Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONBryant Ranch Prepack146b21e6-f8a5-47eb-b2d9-9ed70d1501d92024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 104894
unii: 4AF302ESOS
Mind Detox and DrainageALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUMDeseret Biologicals, Inc.1ac1e955-a374-4cac-b997-51c6aef8d35d2024-08-01WarningsExact identifier
unii: ETJ7Z6XBU4
ondansetronONDANSETRONNuCare Pharmaceuticals,Inc.b297c163-2052-cb22-e053-2995a90a82892024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: ETJ7Z6XBU4
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Argentum Quartz 6XARGENTUM QUARTZ 6XTrue Botanica, LLC1acadf89-d222-9e16-e063-6294a90a80bc2024-06-26WarningsExact identifier
unii: ETJ7Z6XBU4
OndansetronONDANSETRONChartwell RX, LLC4c74336c-11ec-420a-80e1-d8e4a8f1c46d2024-06-24Warnings, Adverse reactionsExact identifier
rxcui: 312087
rxcui: 104894
unii: 4AF302ESOS
ondansetronONDANSETRONNuCare Pharmaceuticals,Inc.a1dd7420-dd81-2c8e-e053-2995a90ac8e62024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 312087
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.8f9fc8a2-0cfd-12f1-e053-2995a90acf3d2024-06-19Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 104894
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.85cd0c27-788d-5fd8-e053-2a91aa0a7c692024-06-14Warnings, Adverse reactionsExact identifier
application number: ANDA090469
ndc (package): 68071-4834-2
ndc (package): 68071-4834-7
ndc (package): 68071-4834-6
ndc (package): 68071-4834-4
ndc (package): 68071-4834-1
ndc (product): 68071-4834
ndc11 (package): 68071483401
rxcui: 104894
spl id: 1ae16ffe-90f9-837f-e063-6394a90afbce
spl set id: 85cd0c27-788d-5fd8-e053-2a91aa0a7c69
unii: 4AF302ESOS
OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.87fd7e8e-fd04-34ad-e053-2a95a90a236d2024-06-14Warnings, Adverse reactionsExact identifier
application number: ANDA090469
rxcui: 104894
unii: 4AF302ESOS
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEASILICEARxhomeo Private Limited d.b.a. Rxhomeo, Inc1a361030-a925-0998-e063-6394a90a915d2024-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Multiple MiasmACONITUM NAPELLUS, ALOE, ARSENICUM ALBUM, AURUM METALLICUM, BRYONIA (ALBA), CACTUS GRANDIFLORUS, CALCAREA SULPHURICA, CINCHONA OFFICINALIS, HURA BRASILIENSIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, PHOSPHORUS, SARCOLACTICUM ACIDUM, SILICEA, STRAMONIUM, SULPHUR, TARENTULA HISPANA, TEUCRIUM MARUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.92c97bf6-8dd9-43a9-b686-75420b0291972024-05-21WarningsExact identifier
unii: ETJ7Z6XBU4
OsteoparEQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OLEUM MORRHUAE, SILICEA, HEKLA LAVAEnergique, Inc.6c346a26-26a2-4be0-b8a3-bbb5709bcf3d2024-05-21WarningsExact identifier
unii: ETJ7Z6XBU4
ColoparCOLON (SUIS), ARSENICUM ALBUM, CAUSTICUM, IGNATIA AMARA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SEPIA, SILICEA, THUJA OCCIDENTALISEnergique, Inc.c47d7203-abcd-4ae5-bf9b-5df07e07d3c12024-05-20WarningsExact identifier
unii: ETJ7Z6XBU4
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.4510fe59-cc28-4585-925f-42508a60abd02024-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
EMF Protect and BalanceALFALFA, FUCUS VESICULOSUS, KALI PHOSPHORICUM, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, FERRUM METALLICUM, CADMIUM SULPHURATUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, YTTERBIUM OXIDE, TARENTULA CUBENSIS, X-RAY, CUPRUM METALLICUM, SILICEADeseret Biologicals, Inc.df7e925e-00d1-4b0c-8a78-ad38148bc3602024-05-09WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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