FDA.reportPublic FDA data

NDC 59148-238 - ABILIFY MAINTENA

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
59148-238
Package NDCs from labels
59148-238-90
Manufacturer
Otsuka America Pharmaceutical, Inc.
Effective date
2026-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ABILIFY MAINTENA - Otsuka America Pharmaceutical, Inc.Otsuka America Pharmaceutical, Inc.2026-03-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59148-238-90ABILIFY MAINTENA1.9 mL in 1 VIAL, SINGLE-USEINJECTION, SUSPENSION, EXTENDED1.9 mL400 mg in 1.9mL27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-238ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]26Unmatched20250417_ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aripiprazoleACTIVE INGREDIENT82VFR53I78ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]9
aripiprazoleACTIVE MOIETY82VFR53I78ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]9
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]9
mannitolINACTIVE INGREDIENT3OWL53L36AABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]9
sodium hydroxideINACTIVE INGREDIENT55X04QC32IABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]9
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]9
WaterINACTIVE INGREDIENT059QF0KO0RABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]9

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 2 of 22 · 423 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.99747897-22fe-4bee-9942-6349c0c8f6b02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limited476b92f3-cf7b-4c09-ac67-6ed35e6811d52026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLE ORALATLANTIC BIOLOGICALS CORP.042b725c-1c17-4cfb-80b2-c841226d795e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC56439ef6-a07e-34c9-e063-6294a90a77c32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC55f3a705-9412-0f88-e063-6294a90a2b532026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLECoupler LLC55f446b0-caa2-aca8-e063-6294a90af4412026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
unii: K679OBS311
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.a1191a90-eb83-4a59-948c-b9774d2c83a52026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack69af5199-f872-4298-8d09-035e2127d3d42026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 593YOG76RN
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 593YOG76RN
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 593YOG76RN
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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