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 1 of 52 · 1,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.b72c0cff-9f4d-42e2-b884-d06dea3e63782026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
aripiprazoleARIPIPRAZOLEApotex Corp.14910dae-da81-3d73-d0a4-e98d13917c692026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
BMNP AURUM METALLICUMAURUM METALLICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a6d9036-3c83-e45f-e063-6394a90aad322026-09-01WarningsExact identifier
unii: 79Y1949PYO
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Viscum CrataegusVISCUM CRATAEGUSUriel Pharmacy Inc.64860e61-2938-4ac7-8072-da1a589463272026-08-21WarningsExact identifier
unii: 79Y1949PYO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 79Y1949PYO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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