FDA.reportPublic FDA data

aripiprazole

Product NDC
68788-7063
11-digit product format
687887063
Labeler code
68788
Product ID
68788-7063_5ef48246-f66f-4839-83df-0c0863b342ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201519
Marketing category
ANDA
Marketing start
2018-01-05
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349553

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
68788-7063-1aripiprazole100 in 1 BOTTLETABLET1009
68788-7063-2aripiprazole20 in 1 BOTTLETABLET209
68788-7063-3aripiprazole30 in 1 CARTONTABLET309
68788-7063-6aripiprazole60 in 1 BOTTLETABLET609
68788-7063-9aripiprazole90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7063ARIPIPRAZOLE TABLET [PREFERRED PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 5 package rows20250205_faa3032b-d9a1-45dd-88be-abb432223f13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349553ARIPiprazole 20 MG Oral TabletPSNfaa3032b-d9a1-45dd-88be-abb432223f139
349553aripiprazole 20 MG Oral TabletSCDfaa3032b-d9a1-45dd-88be-abb432223f139

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7063-168788706301100 TABLET in 1 BOTTLE (68788-7063-1) 100 tablet2018-01-050000-00-00NoNoCurrent
68788-7063-26878870630220 TABLET in 1 BOTTLE (68788-7063-2) 20 tablet2018-01-050000-00-00NoNoCurrent
68788-7063-36878870630330 TABLET in 1 CARTON (68788-7063-3) 30 tablet2018-01-050000-00-00NoNoCurrent
68788-7063-66878870630660 TABLET in 1 BOTTLE (68788-7063-6) 60 tablet2018-01-050000-00-00NoNoCurrent
68788-7063-96878870630990 TABLET in 1 BOTTLE (68788-7063-9) 90 tablet2018-01-050000-00-00NoNoCurrent