Aripiprazole

Product NDC
59651-515
11-digit product format
596510515
Labeler code
59651
Product ID
59651-515_476b92f3-cf7b-4c09-ac67-6ed35e6811d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216208
Marketing category
ANDA
Marketing start
2026-02-18
Substance
ARIPIPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
82VFR53I78ARIPIPRAZOLE129722-12-9ARIPIPRAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-515-03596510515033 BLISTER PACK in 1 CARTON (59651-515-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2026-02-18NoNoHistorical
59651-515-305965105153030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-515-30) 2026-02-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AripiprazoleAurobindo Pharma Limited | APL HEALTHCARE LIMITED2026-02-20Human Prescription Drug Label1