Aripiprazole

Product NDC
68788-8089
11-digit product format
687888089
Labeler code
68788
Product ID
68788-8089_3f8e2e09-8030-4d81-ad7e-4ae76aa7ecaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207105
Marketing category
ANDA
Marketing start
2021-10-05
Substance
ARIPIPRAZOLE
Active strength
5 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
68788-8089-168788808901100 TABLET in 1 BOTTLE (68788-8089-1) 100 tablet2021-10-05NoNoHistorical
68788-8089-26878880890220 TABLET in 1 BOTTLE (68788-8089-2) 20 tablet2021-10-05NoNoHistorical
68788-8089-36878880890330 TABLET in 1 BOTTLE (68788-8089-3) 30 tablet2021-10-05NoNoHistorical
68788-8089-66878880890660 TABLET in 1 BOTTLE (68788-8089-6) 60 tablet2021-10-05NoNoHistorical
68788-8089-96878880890990 TABLET in 1 BOTTLE (68788-8089-9) 90 tablet2021-10-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
AripiprazolePreferred Pharmaceuticals Inc.2025-01-03HUMAN PRESCRIPTION DRUG LABEL5