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 18 of 21 · 419 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
AripiprazoleARIPIPRAZOLENorthStar RxLLCf87dbfe4-5417-47c9-a97f-d246cfc100232023-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
AripiprazoleARIPIPRAZOLESQUARE PHARMACEUTICALS LIMITED0f9b1fd8-a648-45c9-8655-14de07439f342023-07-02Exact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.0a6fa113-6bb2-4f88-af07-ce0914c98ff22023-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
K Phos NeutralSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEBeach Products, Inc.83376725-ee0f-40ad-bd90-31a61b9445cf2023-02-23Adverse reactionsExact identifier
unii: 593YOG76RN
AripiprazoleARIPIPRAZOLEScieGen Pharmaceuticals Inca7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2023-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
RejuvesolSODIUM PYRUVATE, INOSINE, ADENINE, SODIUM PHOSPHATE, DIBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATECitra Labs, LLCbc06c40f-81a0-45e5-80b6-61f67d4450682023-02-14WarningsExact identifier
unii: 593YOG76RN

Reported adverse events (FAERS/openFDA)#

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