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 28 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heavy Metal DetoxALLIUM SATIVUM, ALUMINIUM METALLICUM, ARG. MET., AUR. MET., BARYTA CARB., BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, CADMIUM METALLICUM, CALC. FLUOR., CARBO VEG., CHELIDONIUM MAJUS, CINCHONA, COBALTUM MET., CUPRUM MET., GLYCYRRHIZA GLABRA, HYDROFLUORICUM ACIDUM, IRIS VERSICOLOR, MANGANUM METALLICUM, MERC. VIV., NICCOLUM METALLICUM, OSMIUM METALLICUM, PLATINUM MET., PLUMB. MET., STANNUM MET., STRONTIUM CARB., THALLIUM METALLICUM, TITANIUM METALLICUM, CARDUUS MAR., TARAXACUMNewton Laboratories, Inc.9bd05208-1d6e-ab85-e053-2a95a90af38e2025-02-06WarningsExact identifier
unii: 79Y1949PYO
unii: D1JT611TNE
unii: CPD4NFA903
Heavy Metal DetoxALLIUM SATIVUM, ALUMINIUM METALLICUM, ARG. MET., AUR. MET., BARYTA CARB., BERYLLIUM METALLICUM, BISMUTHUM METALLICUM, CADMIUM METALLICUM, CALC. FLUOR., CARBO VEG., CHELIDONIUM MAJUS, CINCHONA, COBALTUM MET., CUPRUM MET., GLYCYRRHIZA GLABRA, HYDROFLUORICUM ACIDUM, IRIS VERSICOLOR, MANGANUM METALLICUM, MERC. VIV., NICCOLUM METALLICUM, OSMIUM METALLICUM, PLATINUM MET., PLUMB. MET., STANNUM MET., STRONTIUM CARB., THALLIUM METALLICUM, TITANIUM METALLICUM, CARDUUS MAR., TARAXACUMNewton Laboratories, Inc.9c07cc66-6a78-770a-e053-2a95a90a585c2025-02-06WarningsExact identifier
unii: 79Y1949PYO
unii: D1JT611TNE
unii: CPD4NFA903
PRIDICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.d22eca2f-d7e6-3412-e053-2995a90a63842025-02-05WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 6X 12SILICEAZettl Health Inc.2d5d1bf7-3754-1f60-e063-6294a90aee062025-02-04Exact identifier
unii: ETJ7Z6XBU4
OPIPZAARIPIPRAZOLECarwin Pharmaceutical Associates, LLCb47ede68-8942-4432-af7e-57afc14b2ba42025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.c040bd1d-45b7-49f2-93ea-aed7220b30ac2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
Cerebellum Thalamus B AurumCEREBELLUM THALAMUS B AURUMUriel Pharmacy Inc.11e638f3-feb5-579d-e063-6394a90a5d562025-01-25WarningsExact identifier
unii: 79Y1949PYO
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
Olibanum Belladonna comp.OLIBANUM BELLADONNA COMP.Uriel Pharmacy, Inc2c778131-9962-879a-e063-6394a90a56bb2025-01-24WarningsExact identifier
unii: 79Y1949PYO
Cinis urtica 8X. Mercurius auratus 15XCINIS URTIC 8X. MERCURIUS AURATUS 15XUriel Pharmacy, Inc2c77e52e-f567-394e-e063-6294a90a0a3a2025-01-24WarningsExact identifier
unii: 79Y1949PYO
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
AripiprazoleARIPIPRAZOLELannett Company, Inc.e7292c4c-e332-4ed4-9086-f130d223b6ae2025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
AripiprazoleARIPIPRAZOLEDirect_Rxf823bc23-27f3-2397-e053-6294a90a365a2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxf81d9b82-5879-3c0a-e053-6294a90ac23e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxfacdb9a9-612f-e59a-e053-6394a90a1fa72025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEDirect_Rxfcea91c3-e428-8991-e053-6394a90a099d2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78

Reported adverse events (FAERS/openFDA)#

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