Aripiprazole

Product NDC
76282-044
11-digit product format
762820044
Labeler code
76282
Product ID
76282-044_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
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490, 349545, 349547, 349553, 402131, 602964

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-044-0176282004401100 TABLET in 1 BOTTLE (76282-044-01) 100 tablet2016-10-070000-00-00NoNoCurrent
76282-044-307628200443030 TABLET in 1 BOTTLE (76282-044-30) 30 tablet2016-10-070000-00-00NoNoCurrent