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 11 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Berberis QuartzBERBERIS QUARTZUriel Pharmacy Inc.5da48d70-1140-495d-b672-0e55c04196e12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
Viscum BelladonnaVISCUM BELLADONNAUriel Pharmacy Inc.a4865726-445e-4cb7-b7c8-5b74b8dd48162026-01-16WarningsExact identifier
unii: 79Y1949PYO
Aurum StibiumAURUM STIBIUMUriel Pharmacy Inc.bd35c88f-c646-4136-e053-2a95a90a0cc12026-01-16WarningsExact identifier
unii: 79Y1949PYO
Aurum Stibium Hyoscyamus48951-1405-1Uriel Pharmacy, Inc3dd7da72-ab65-696f-e063-6294a90a3ef12026-01-16WarningsExact identifier
unii: 79Y1949PYO
Aurum 21XAURUM 21XUriel Pharmacy Inc.93f243c0-b963-9ea0-e053-2995a90aa8522026-01-16WarningsExact identifier
unii: 79Y1949PYO
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Amber AmethystAMBER AMETHYSTUriel Pharmacy, Inc4837e805-a777-c1fa-e063-6294a90ae9c42026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 79Y1949PYO
Bio Galium PhaseAPIS MELLIFICA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALTHA PALUSTRIS, CLEMATIS ERECTA, CORTISONE ACETICUM, ECHINACEA (ANGUSTIFOLIA), GAERTNER BACILLUS (BACH), GALIUM APARINE, HEDERA HELIX, JUNIPERUS COMMUNIS, NITRICUM ACIDUM, ONONIS SPINOSA, PHOSPHORUS, SEDUM ACRE, SEMPERVIVUM TECTORUM, THUJA OCCIDENTALIS, URTICA URENSDeseret Biologicals, Inc.902f38c5-b870-4313-9b0b-e69ca357d8442026-01-09WarningsExact identifier
unii: 79Y1949PYO
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Low Vaccinosis Nosode 4024LOW VACCINOSIS NOSODEProfessional Complementary Health Formulasf347ac8f-ac05-46ef-91a3-9f7e000347682026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Metex 6013METEXProfessional Complementary Health Formulas78371ca3-50a6-46f0-8ea6-7de57c5163752026-01-08WarningsExact identifier
unii: D1JT611TNE

Reported adverse events (FAERS/openFDA)#

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