Aripiprazole

Product NDC
76282-048
11-digit product format
762820048
Labeler code
76282
Product ID
76282-048_ae9e2824-8741-4973-b349-a18ce05cb334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA205064
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
76282-048-0176282004801100 TABLET in 1 BOTTLE (76282-048-01) 100 tablet2016-10-07NoNoHistorical
76282-048-307628200483030 TABLET in 1 BOTTLE (76282-048-30) 30 tablet2016-10-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AripiprazoleExelan Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc.2018-12-28Human Prescription Drug Label2