FDA.reportPublic FDA data

NDC 43485-101-01 - Spritam

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
43485-101
Requested NDC
43485-101-01
Package NDCs from labels
43485-101-01, 43485-101-60, 43485-101-03
Manufacturer
Aprecia Pharmaceuticals, LLC
Effective date
2025-10-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Spritam - Aprecia Pharmaceuticals, LLCAprecia Pharmaceuticals, LLC2025-10-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43485-101-01Spritam1 in 1 BLISTER PACKTABLET, FOR SUSPENSION129
43485-101-03Spritam6 in 1 CARTONTABLET, FOR SUSPENSION629
43485-101-60Spritam60 in 1 CARTONTABLET, FOR SUSPENSION6029

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43485-101SPRITAM (LEVETIRACETAM) TABLET, FOR SUSPENSION [APRECIA PHARMACEUTICALS, LLC]26Current NDC, Legacy NDC, 3 package rows20241222_be651c31-383f-11e4-916c-0800200c9a66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43485-101-01EA - Each43485-101896fe2d2-0b5d-4f2e-94f5-b1c1c5505b3612016-03-04
43485-101-60EA - Each43485-101c7fa9dc8-dccc-453a-976c-ea00b52ea90112016-03-04

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 43 of 57 · 1,135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Multiple MiasmARSENICUM ALBUM, LYCOPODIUM CLAVATUM, SULPHUR, ALOE, CARCINOSIN, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALISDeseret Biologicals, Inc.0cf54ec3-d731-4f27-89fd-4571d991a6152024-05-09WarningsExact identifier
unii: ETJ7Z6XBU4
OsteoparEQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OSSA SEPIA, SILICEA, HEKLA LAVAEnergique, Inc.daf83dbf-bbf4-49e2-ade1-1d86f3e526752024-05-09WarningsExact identifier
unii: ETJ7Z6XBU4
Occuloplex IEUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENEBioActive Nutritional, Inc.c2c9b577-4f75-4ddc-815f-46c3bb9b46d22024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
LymphoplusTRIFOLIUM PRATENSE, LYMPH NODE (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), LYCOPODIUM CLAVATUM, MYRRHA, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEADeseret Biologicals, Inc.92f6fc6b-58c0-4137-88b3-bee2118aeb292024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.a1b42f4b-4029-4008-b950-a7725f34b43d2024-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.04dfad30-9496-43c6-8ce8-ab04fdb9ce3b2024-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
levetiracetamLEVETIRACETAMBaxter Healthcare Corporation3d88adda-9580-44bf-b75c-d615c973c1e12024-05-06Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
unii: PDC6A3C0OX
AI MiasmASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMEnergique, Inc.df829e4a-c982-4d02-b318-38b1fbc5072d2024-05-02WarningsExact identifier
unii: ETJ7Z6XBU4
Levetiracetam in Sodium ChlorideLEVETIRACETAMNexus Pharmaceuticals LLCee014183-a857-457b-9573-0cc168e560f32024-04-30Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMCamber Pharmaceuticals, Inc.63b36274-89f0-42d8-9f09-f9e78e179af42024-04-29Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
VACC HCHEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUMDeseret Biologicals, Inc.a98082ba-21ec-4cf8-b81c-bcb41eb9fd122024-04-23WarningsExact identifier
unii: ETJ7Z6XBU4
LevetiracetamLEVETIRACETAMB. Braun Medical Inc.ad32ec2f-b4e0-4811-8ea1-7a4abdd5c0a62024-04-23Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LigaparLAPPA MAJOR, LIGAMENT (HUMAN), CARTILAGO SUIS, ARNICA MONTANA, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CAUSTICUM, RHODODENDRON CHRYSANTHUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, ZINCUM METALLICUMEnergique, Inc.17f6b1f5-8e49-49df-bad4-9c19fa677e692024-04-22WarningsExact identifier
unii: ETJ7Z6XBU4
VisioparEUPHRASIA OFFICINALIS, EYE (SUIS), AURUM METALLICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, MAGNESIA CARBONICA, PHOSPHORUS, SILICEA, PHYSOSTIGMA VENENOSUM, OSMIUM METALLICUM, THUJA OCCIDENTALISEnergique, Inc.811f7626-0d21-49bd-8c31-9a5abec45c132024-04-19WarningsExact identifier
unii: ETJ7Z6XBU4
EVTOXCOCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODEBioActive Nutritional, Inc.4b518e10-9ce0-492b-92be-6025d8d7c3c62024-04-19WarningsExact identifier
unii: ETJ7Z6XBU4
levetiracetamLEVETIRACETAMSagent Pharmaceuticalsd2de9565-0c0b-4957-bafa-1a286103709e2024-04-18Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Levetiracetam in Sodium ChlorideLEVETIRACETAM IN SODIUM CHLORIDEHikma Pharmaceuticals USA Inc.c723fd27-214c-45f6-b170-a3b807ffab072024-04-12Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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