Aripiprazole

Product NDC
68071-3848
11-digit product format
680713848
Labeler code
68071
Product ID
68071-3848_3cf72865-97f2-2fea-e063-6394a90ab9cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA205064
Marketing category
ANDA
Marketing start
2015-04-28
Substance
ARIPIPRAZOLE
Active strength
5 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
68071-3848-36807138480330 TABLET in 1 BOTTLE (68071-3848-3) 30 tablet2025-08-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AripiprazoleNuCare Pharmaceuticals, Inc.2025-08-22HUMAN PRESCRIPTION DRUG LABEL1