FDA.reportPublic FDA data

NDC 59148-034-13 - Abilify MyCite

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
59148-034
Requested NDC
59148-034-13
Package NDCs from labels
59148-034-13, 59148-034-61, 59148-034-72
Manufacturer
Otsuka America Pharmaceutical, Inc.
Effective date
2025-01-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Abilify MyCite - Otsuka America Pharmaceutical, Inc.Otsuka America Pharmaceutical, Inc.2025-01-31HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
59148-034-612021-08-02These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002
59148-034-722021-08-02These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002
59148-034-852021-08-02These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002
59148-034-902021-08-02These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002
59148-034-612021-07-23These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002
59148-034-722021-07-23These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002
59148-034-852021-07-23These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002
59148-034-902021-07-23These highlights do not include all the information needed to use ABILIFY MYCITE safely and effectively. See full prescribing information for ABILIFY MYCITE. ABILIFY MYCITE ® (aripiprazole tablets with sensor), for oral use Initial U.S. Approval: 2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-034ABILIFY MYCITE (ARIPIPRAZOLE) TABLET WITH SENSOR [OTSUKA AMERICA PHARMACEUTICAL, INC.]16Legacy NDC20250202_e8787c3f-5e41-42d1-8091-44b56346620f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-034-61EA - Each59148-034ddb8cc1c-aa89-4efe-bc8a-25a9d4744ab212021-06-02
59148-034-72EA - Each59148-034d88eb733-3395-42bc-81d6-53810e3af78f12021-06-02
59148-034-85EA - Each59148-0349af47f30-3b3c-4372-aca3-c14b304f105612018-12-13

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 45 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Unda 18CONDURANGO, LYCOPODIUM CLAVATUM, VIBURNUM PRUNIFOLIUM, THUJA OCCIDENTALIS, CAMPHORA, CUPRUM METALLICUM, ALUMINIUM METALLICUM, STIBIUM METALLICUMSeroyal USA0e71305f-4b5a-6d5a-e054-00144ff88e882022-11-09WarningsExact identifier
unii: CPD4NFA903
UNDA 19ALUMINIUM METALLICUM, DROSERA, ILLICIUM VERUM, MENTHA PIPERITA, SENEGA OFFICINALISSeroyal USA4c47f5cd-fcb3-3ecb-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: CPD4NFA903
Unda 24CRATAEGUS FRUIT, PASSIFLORA INCARNATA, BOLDO LEAF, VALERIANA OFFICINALIS ROOT, CHAMOMILLA, ALUMINIUM METALLICUMSeroyal USA0fd99c06-1ea8-7171-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: CPD4NFA903
UNDA 28LACTUCA VIROSA, TARAXACUM OFFICINALE, SARSAPARILLA, SPIRAEA ULMARIA, CONDURANGO, ALUMINIUM METALLICUM, CUPRUM METALLICUM, STANNUM METALLICUMSeroyal USA182f4ad8-edf9-468c-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: 79Y1949PYO
unii: CPD4NFA903
UNDA 29ABSINTHIUM, ALLIUM CEPA, ARGENTUM METALLICUM, BETULA PENDULA SAP, LAMIUM ALBUM, SALVIA OFFICINALISSeroyal USA20484d33-4389-1a85-e054-00144ff88e882022-11-09WarningsExact identifier
unii: CPD4NFA903
Unda 33ALLIUM CEPA, TILIA EUROPAEA, JATEORHIZA PALMATA, VIOLA TRICOLOR, BOLDO LEAF, ANACARDIUM ORIENTALE FRUI, ALUMINIUM METALLICUMSeroyal USA0e728819-0a1f-26e6-e054-00144ff88e882022-11-09WarningsExact identifier
unii: CPD4NFA903
UNDA 35AURUM METALLICUM, CORALLIUM RUBRUM EXOSKELETON, CRATAEGUS, GRINDELIA, HAMAMELIS VIRGINIANA, MENTHA PIPERITA, MYRTUS COMMUNISSeroyal USA1f64baba-eb29-30c6-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: 79Y1949PYO
Unda 36ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, ALUMINIUM METALLICUM, CHELIDONIUM MAJUS, HAMAMELIS VIRGINIANA, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUMSeroyal USA26e7d64b-1a94-6de4-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: CPD4NFA903
UNDA 43ALUMINIUM METALLICUM, ASPERULA ODORATA, EQUISETUM ARVENSE, JATEORHIZA PALMATA, MARRUBIUM VULGARE, OCIMUM BASILICUM, STANNUM METALLICUMSeroyal USA20569964-d505-03e2-e054-00144ff8d46c2022-11-09WarningsExact identifier
unii: 79Y1949PYO
unii: CPD4NFA903
UNDA 49AURUM METALLICUM, CONDURANGO BARK, HYPERICUM PERFORATUM, OCIMUM BASILICUM, PLUMBUM METALLICUMSeroyal USA205ac635-cdf2-1b1d-e054-00144ff88e882022-11-09WarningsExact identifier
unii: 79Y1949PYO
UNDA 2PETROSELINUM SATIVUM, RHAMNUS FRANGULA, THLASPI BURSA-PASTORIS, JUNIPERUS COMMUNIS, ASPARAGUS OFFICINALIS, BERBERIS VULGARIS, GENISTA TINCTORIA, ARGENTUM METALLICUMSeroyal USA079c945e-7853-3410-e054-00144ff88e882022-10-25WarningsExact identifier
unii: 79Y1949PYO
Magnesium MetallicumMAGNESIUM METALLICUMHahnemann Laboratories, INC.e8a8ae26-41ef-39c8-e053-2995a90ab68a2022-09-14Exact identifier
unii: I38ZP9992A
ARIPIPRAZOLEARIPIPRAZOLEA-S Medication Solutionsaaf7dc7e-04f3-442b-86d7-5f54d17d102c2022-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
Titanium MetallicumTITANIUM METALLICUMHahnemann Laboratories, INC.e5e8ac6c-aa30-202c-e053-2a95a90a54382022-08-10Exact identifier
unii: D1JT611TNE
AripiprazoleARIPIPRAZOLENCS HealthCare of KY, LLC dba Vangard Labs8da99c93-613e-4b78-9f91-3efc2dea194d2022-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEProficient Rx LP19a3c2f2-11eb-4ec9-ac38-134168bdf99c2022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Unda 44INULA HELENIUM ROOT, JUNIPERUS COMMUNIS BERRY, UVA-URSI LEAF, DULCAMARA STEM AND LEAF, CYTISUS SCOPARIUS AERIAL PARTS, STIGMATA MAIDIS STYLE AND STIGMA, ARGENTUM METALLICUM, AURUM METALLICUMSeroyal USA0a6df6e1-fe50-0f3e-e054-00144ff8d46c2022-07-07WarningsExact identifier
unii: 79Y1949PYO

Reported adverse events (FAERS/openFDA)#

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