FDA.reportPublic FDA data

Abilify Asimtufii

Product NDC
59148-114
11-digit product format
591480114
Labeler code
59148
Product ID
59148-114_284a898a-06c2-4ef9-9cb9-5d3e6cf94f9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
INJECTION, SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
Labeler
Otsuka America Pharmaceutical, Inc
Application
NDA217006
Marketing category
NDA
Marketing start
2023-04-27
Substance
ARIPIPRAZOLE
Active strength
960 mg/3.2mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Abilify Asimtufii
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE960 mg/3.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui2636637, 2636640, 2636645, 2636646

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
59148-114-80Abilify Asimtufii3.2 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED3.26
59148-114-80Abilify Asimtufii1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED16
59148-114-92Abilify Asimtufii1 in 1 CARTONINJECTION, SUSPENSION, EXTENDED16
59148-114-92Abilify Asimtufii3.2 mL in 1 SYRINGEINJECTION, SUSPENSION, EXTENDED3.26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-114-80ML - Milliliter59148-114f7f65b51-590c-4ec6-9efb-a6f84cd45a5f12023-06-06
59148-114-92ML - Milliliter59148-114194d4bcb-e2f4-4f09-8d08-c7a72c88623612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-114ABILIFY ASIMTUFII (ARIPIPRAZOLE) INJECTION, SUSPENSION, EXTENDED RELEASE [OTSUKA AMERICA PHARMACEUTICAL, INC]6Current NDC, 4 package rows20250410_da4c07fd-1130-4341-bb44-63acfa4162be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2636640Abilify Asimtufii 720 MG in 2.4 ML Extended Release Prefilled SyringePSNda4c07fd-1130-4341-bb44-63acfa4162be6
2636646Abilify Asimtufii 960 MG in 3.2 ML Extended Release Prefilled SyringePSNda4c07fd-1130-4341-bb44-63acfa4162be6
2636637ARIPiprazole 720 MG in 2.4 ML Extended Release Prefilled SyringePSNda4c07fd-1130-4341-bb44-63acfa4162be6
2636645ARIPiprazole 960 MG in 3.2 ML Extended Release Prefilled SyringePSNda4c07fd-1130-4341-bb44-63acfa4162be6
26366402.4 ML aripiprazole 300 MG/ML Prefilled Syringe [Abilify]SBDda4c07fd-1130-4341-bb44-63acfa4162be6
26366463.2 ML aripiprazole 300 MG/ML Prefilled Syringe [Abilify]SBDda4c07fd-1130-4341-bb44-63acfa4162be6
26366372.4 ML aripiprazole 300 MG/ML Prefilled SyringeSCDda4c07fd-1130-4341-bb44-63acfa4162be6
26366453.2 ML aripiprazole 300 MG/ML Prefilled SyringeSCDda4c07fd-1130-4341-bb44-63acfa4162be6
26366402.4 ML Abilify 300 MG/ML Prefilled SyringeSYda4c07fd-1130-4341-bb44-63acfa4162be6
26366463.2 ML Abilify 300 MG/ML Prefilled SyringeSYda4c07fd-1130-4341-bb44-63acfa4162be6
2636640Abilify Asimtufii 720 MG per 2.4 ML extended release Prefilled SyringeSYda4c07fd-1130-4341-bb44-63acfa4162be6
2636646Abilify Asimtufii 960 MG per 3.2 ML extended release Prefilled SyringeSYda4c07fd-1130-4341-bb44-63acfa4162be6
2636637aripiprazole 720 MG per 2.4 ML extended release Prefilled SyringeSYda4c07fd-1130-4341-bb44-63acfa4162be6
2636645aripiprazole 960 MG per 3.2 ML extended release Prefilled SyringeSYda4c07fd-1130-4341-bb44-63acfa4162be6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59148-114-80591480114801 SYRINGE in 1 CARTON (59148-114-80) / 3.2 mL in 1 SYRINGE1 syringe2023-04-27NoNoCurrent
59148-114-92591480114921 SYRINGE in 1 CARTON (59148-114-92) / 3.2 mL in 1 SYRINGE1 syringe2023-04-27YesNoCurrent