Aripiprazole

Product NDC
46708-258
11-digit product format
467080258
Labeler code
46708
Product ID
46708-258_5108607e-5633-4b19-82f9-6c48720960c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA202101
Marketing category
ANDA
Marketing start
2015-04-28
Substance
ARIPIPRAZOLE
Active strength
20 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
46708-258-1046708025810100 TABLET in 1 CARTON (46708-258-10) 100 tablet2015-04-28NoNoHistorical
46708-258-304670802583030 TABLET in 1 BOTTLE (46708-258-30) 30 tablet2015-04-28NoNoHistorical
46708-258-3146708025831100 TABLET in 1 BOTTLE (46708-258-31) 100 tablet2015-04-28NoNoHistorical
46708-258-7146708025871500 TABLET in 1 BOTTLE (46708-258-71) 500 tablet2015-04-28NoNoHistorical
46708-258-91467080258911000 TABLET in 1 BOTTLE (46708-258-91) 1000 tablet2015-04-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AripiprazoleAlembic Pharmaceuticals Limited2023-01-27Human Prescription Drug Label3