FDA.reportPublic FDA data

Aripiprazole

Product NDC
68788-7808
11-digit product format
687887808
Labeler code
68788
Product ID
68788-7808_640953ec-6b90-4317-88db-233fe18656bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Prefferred Pharmaceuticals Inc.
Application
ANDA207105
Marketing category
ANDA
Marketing start
2020-10-28
Substance
ARIPIPRAZOLE
Active strength
10 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
ARIPIPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349545

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7808-1Aripiprazole100 in 1 BOTTLETABLET1006
68788-7808-2Aripiprazole20 in 1 BOTTLETABLET206
68788-7808-3Aripiprazole30 in 1 BOTTLETABLET306
68788-7808-6Aripiprazole60 in 1 BOTTLETABLET606
68788-7808-9Aripiprazole90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7808ARIPIPRAZOLE TABLET [PREFFERRED PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 5 package rows20250205_fbb3ac69-8dba-42df-8d6d-ef3d79241edb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSNfbb3ac69-8dba-42df-8d6d-ef3d79241edb6
349545aripiprazole 10 MG Oral TabletSCDfbb3ac69-8dba-42df-8d6d-ef3d79241edb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7808-168788780801100 TABLET in 1 BOTTLE (68788-7808-1) 100 tablet2020-10-280000-00-00NoNoCurrent
68788-7808-26878878080220 TABLET in 1 BOTTLE (68788-7808-2) 20 tablet2020-10-280000-00-00NoNoCurrent
68788-7808-36878878080330 TABLET in 1 BOTTLE (68788-7808-3) 30 tablet2020-10-280000-00-00NoNoCurrent
68788-7808-66878878080660 TABLET in 1 BOTTLE (68788-7808-6) 60 tablet2020-10-280000-00-00NoNoCurrent
68788-7808-96878878080990 TABLET in 1 BOTTLE (68788-7808-9) 90 tablet2020-10-280000-00-00NoNoCurrent