Aripiprazole

Product NDC
0615-8524
11-digit product format
006158524
Labeler code
0615
Product ID
0615-8524_b4492067-a61a-4f62-a09a-ae26e8f35baa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA206383
Marketing category
ANDA
Marketing start
2020-03-16
Substance
ARIPIPRAZOLE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
82VFR53I78ARIPIPRAZOLE129722-12-9ARIPIPRAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8524-390061585243930 TABLET in 1 BLISTER PACK (0615-8524-39) 30 tablet2024-09-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AripiprazoleNCS HealthCare of KY, LLC dba Vangard Labs2024-10-25HUMAN PRESCRIPTION DRUG LABEL1