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 5 of 21 · 419 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: K679OBS311
Discount Drug Mart Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMDiscount Drug Mart4ba1b369-54e2-5224-e063-6394a90a47692026-02-25WarningsExact identifier
unii: K679OBS311
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4bafa882-50b7-e3e2-e063-6294a90a76e32026-02-25WarningsExact identifier
unii: K679OBS311
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.2bc00231-c2e7-4b9d-93a1-fb796fd8d5912026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1e8d889e-126b-4627-a2cc-34f2d35a5d672026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1ef9e44f-5672-47c2-97e9-286e1b84417d2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
unii: K679OBS311
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
unii: K679OBS311
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack4bda6f17-d87c-4009-b329-99275c56106f2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackfb40b669-4e37-4087-8fb1-3ac1405436022026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 82VFR53I78
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Family Care Single Use Lubricant Eye Drop 0.4mL 5ctCARBOXYMETHYLCELLULOSE SODIUMUnited Exchange Corp48879feb-b5ae-a9e6-e063-6394a90a03b22026-01-16WarningsExact identifier
unii: K679OBS311
Family Care Single Use Lubricant Eye Drop 0.4mL 30ctCARBOXYMETHYL CELLULOSE 0.5%United Exchange Corp488b3363-8d06-7dcc-e063-6294a90ab44c2026-01-16WarningsExact identifier
unii: K679OBS311
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
unii: K679OBS311
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
unii: K679OBS311
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
TheraTears Dry and TiredCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC02b70e2d-8159-4637-a282-9eac1468e7862026-01-07WarningsExact identifier
unii: K679OBS311

Reported adverse events (FAERS/openFDA)#

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