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 43 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VitalizerECHINACEA (ANGUSTIFOLIA), IODIUM, ARSENICUM ALBUM, AURUM METALLICUM, CALCAREA FLUORICA, GALLICUM ACIDUM, HEKLA LAVA, NICCOLUM SULPHURICUM, PHOSPHORUS, SEDUM ACRE, SEMPERVIVUM TECTORUM, SENECIO AUREUS, BLATTA AMERICANA, ONOSMODIUM VIRGINIANUMBioActive Nutritional, Inc.a643abc6-5367-4b34-848a-83bdb6ddd87d2023-04-06WarningsExact identifier
unii: 79Y1949PYO
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675
Aurum metallicumGOLDBoiron84f0f339-5427-b584-e053-2991aa0a220a2023-03-28Exact identifier
unii: 79Y1949PYO
SiliceaSILICON DIOXIDEBoiron86d34721-7dfc-bf91-e053-2991aa0a70ae2023-03-27Exact identifier
unii: ETJ7Z6XBU4
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
AripiprazoleARIPIPRAZOLEScieGen Pharmaceuticals Inca7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2023-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Aurum metallicumGOLDBoiron84625779-41fd-547e-e053-2991aa0a205a2023-02-20Exact identifier
unii: 79Y1949PYO
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4
Aurum metallicumGOLDBoiron84f10008-5c27-43b4-e053-2a91aa0a64b92023-02-20Exact identifier
unii: 79Y1949PYO
Aurum metallicumGOLDBoiron8462be19-1f01-790b-e053-2991aa0ad29d2023-02-20Exact identifier
unii: 79Y1949PYO
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: ETJ7Z6XBU4
CellTropinARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUSMicro Balance Health Products LLC502d3ffa-bbf4-403a-9fad-b6b229f36a8c2023-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
Aluminum MetallicumALUMINUM METALLICUMHahnemann Laboratories, INC.f49f4a93-d9a6-0964-e053-2995a90a867e2023-02-13Exact identifier
unii: CPD4NFA903
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Limited4f1691a8-724e-430d-9bab-27b59ef9bd4e2023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Limited793fc904-2f11-4f97-a0ac-4d6910cac0f92023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
SiliceaSILICON DIOXIDEBoiron86d2db09-9c46-37f7-e053-2a91aa0a326f2023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b50e-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b4fb-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.b284b294-40a0-4ccd-b7b7-b61267cd4e762023-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78

Reported adverse events (FAERS/openFDA)#

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