Abilify MyCite

Product NDC
59148-034
11-digit product format
591480034
Labeler code
59148
Product ID
59148-034_3cbd66b3-7c90-44fc-9c44-3f290e6144e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
TABLET WITH SENSOR
Route
ORAL
Labeler
Otsuka America Pharmaceutical, Inc.
Application
NDA207202
Marketing category
NDA
Marketing start
2018-01-31
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-034-61EA - Each59148-034ddb8cc1c-aa89-4efe-bc8a-25a9d4744ab212021-06-02
59148-034-72EA - Each59148-034d88eb733-3395-42bc-81d6-53810e3af78f12021-06-02
59148-034-85EA - Each59148-0349af47f30-3b3c-4372-aca3-c14b304f105612018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-034ABILIFY MYCITE (ARIPIPRAZOLE) TABLET WITH SENSOR [OTSUKA AMERICA PHARMACEUTICAL, INC.]16Legacy NDC20250202_e8787c3f-5e41-42d1-8091-44b56346620f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59148-034-61591480034611 BOTTLE in 1 KIT (59148-034-61) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-034-13) 1 bottle2020-12-190000-00-00NoNoCurrent
59148-034-72591480034721 BOTTLE in 1 KIT (59148-034-72) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-034-13) 1 bottle2020-12-190000-00-00NoNoCurrent
59148-034-85591480034851 BOTTLE in 1 KIT (59148-034-85) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-034-13) 1 bottle2018-01-310000-00-00NoNoCurrent
59148-034-90591480034901 BOTTLE in 1 KIT (59148-034-90) > 7 TABLET WITH SENSOR in 1 BOTTLE (59148-034-07) 1 bottle2018-01-310000-00-00NoNoCurrent