FDA.reportPublic FDA data

Aripiprazole

Product NDC
68788-7749
11-digit product format
687887749
Labeler code
68788
Product ID
68788-7749_66441958-c5c0-48a4-850d-bfee07ecff4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA206174
Marketing category
ANDA
Marketing start
2020-07-01
Substance
ARIPIPRAZOLE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui402131

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
68788-7749-1Aripiprazole100 in 1 BOTTLETABLET1007
68788-7749-2Aripiprazole20 in 1 BOTTLETABLET207
68788-7749-3Aripiprazole30 in 1 BOTTLETABLET307
68788-7749-6Aripiprazole60 in 1 BOTTLETABLET607
68788-7749-9Aripiprazole90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7749ARIPIPRAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20250205_36fb0c13-dfae-46ac-bb71-0b53fe5649f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSN36fb0c13-dfae-46ac-bb71-0b53fe5649f47
402131aripiprazole 5 MG Oral TabletSCD36fb0c13-dfae-46ac-bb71-0b53fe5649f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7749-168788774901100 TABLET in 1 BOTTLE (68788-7749-1) 100 tablet2020-07-010000-00-00NoNoCurrent
68788-7749-26878877490220 TABLET in 1 BOTTLE (68788-7749-2) 20 tablet2020-07-010000-00-00NoNoCurrent
68788-7749-36878877490330 TABLET in 1 BOTTLE (68788-7749-3) 30 tablet2020-07-010000-00-00NoNoCurrent
68788-7749-66878877490660 TABLET in 1 BOTTLE (68788-7749-6) 60 tablet2020-07-010000-00-00NoNoCurrent
68788-7749-96878877490990 TABLET in 1 BOTTLE (68788-7749-9) 90 tablet2020-07-010000-00-00NoNoCurrent