Aripiprazole

Product NDC
68071-3850
11-digit product format
680713850
Labeler code
68071
Product ID
68071-3850_3726d102-dda0-645e-e063-6294a90aeb9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205064
Marketing category
ANDA
Marketing start
2020-10-01
Substance
ARIPIPRAZOLE
Active strength
10 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
68071-3850-36807138500330 TABLET in 1 BOTTLE (68071-3850-3) 30 tablet2025-05-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AripiprazoleNuCare Pharmaceuticals,Inc.2025-06-09HUMAN PRESCRIPTION DRUG LABEL1