FDA.reportPublic FDA data

ABILIFY MAINTENA

Product NDC
59148-245
11-digit product format
591480245
Labeler code
59148
Product ID
59148-245_30e40a02-9942-4914-8d84-cf5a8058cec6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
KIT
Labeler
Otsuka America Pharmaceutical, Inc.
Application
NDA202971
Marketing category
NDA
Marketing start
2025-02-28
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ABILIFY MAINTENA
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1602163, 1602171, 1602604, 1602607, 1659812, 1659814, 1659816, 1659818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

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
59148-245-12ABILIFY MAINTENA1 in 1 CARTONKIT127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-245-12EA - Each59148-245dd78d7a7-003c-4529-92f7-0753725c27e412025-05-14

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-245ABILIFY MAINTENA (ARIPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]26Current NDC, 2 package rows20250417_ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659818Abilify Maintena 300 MG Extended Release InjectionPSNee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602604Abilify Maintena 300 MG Extended Release Prefilled SyringePSNee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659814Abilify Maintena 400 MG Extended Release InjectionPSNee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602607Abilify Maintena 400 MG Extended Release Prefilled SyringePSNee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659816ARIPiprazole 300 MG Extended Release InjectionPSNee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602163ARIPiprazole 300 MG Extended Release Prefilled SyringePSNee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659812ARIPiprazole 400 MG Extended Release InjectionPSNee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602171ARIPiprazole 400 MG in 2 ML Extended Release Prefilled SyringePSNee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
16026041.5 ML aripiprazole 200 MG/ML Prefilled Syringe [Abilify]SBDee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
16026072 ML aripiprazole 200 MG/ML Prefilled Syringe [Abilify]SBDee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659818aripiprazole 300 MG Injection [Abilify]SBDee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659814aripiprazole 400 MG Injection [Abilify]SBDee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
16021631.5 ML aripiprazole 200 MG/ML Prefilled SyringeSCDee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
16021712 ML aripiprazole 200 MG/ML Prefilled SyringeSCDee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659816aripiprazole 300 MG InjectionSCDee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659812aripiprazole 400 MG InjectionSCDee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
16026041.5 ML Abilify 200 MG/ML Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
16026041.5 ML Abilify Maintena 200 MG/ML Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
16026072 ML Abilify 200 MG/ML Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
16026072 ML Abilify Maintena 200 MG/ML Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659818Abilify 300 MG InjectionSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659814Abilify 400 MG InjectionSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602604Abilify Maintena 300 MG extended release Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659818Abilify Maintena 300 MG InjectionSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602604Abilify Maintena 300 MG per 1.5 ML extended release Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602607Abilify Maintena 400 MG extended release Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1659814Abilify Maintena 400 MG InjectionSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602607Abilify Maintena 400 MG per 2 ML extended release Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602163aripiprazole 300 MG extended release Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602163aripiprazole 300 MG per 1.5 ML extended release Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602171aripiprazole 400 MG extended release Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627
1602171aripiprazole 400 MG per 2 ML extended release Prefilled SyringeSYee49f3b1-1650-47ff-9fb1-ea53fe0b92b627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59148-238-90591480238901.9 mL in 1 VIAL, SINGLE-USE1.9 mlHistorical
59148-245-12591480245121 KIT in 1 CARTON (59148-245-12) * 1.9 mL in 1 VIAL, SINGLE-USE (59148-238-90) * 2.5 mL in 1 VIAL, SINGLE-USE (59148-100-12) 1 kit2025-02-28NoNoCurrent