FDA.reportPublic FDA data

Aripiprazole

Product NDC
68788-7733
11-digit product format
687887733
Labeler code
68788
Product ID
68788-7733_59fb868b-1db2-4559-9bf7-22b62500c8ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA207105
Marketing category
ANDA
Marketing start
2020-07-01
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
Rxcui602964

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
68788-7733-1Aripiprazole100 in 1 BOTTLETABLET1006
68788-7733-2Aripiprazole20 in 1 BOTTLETABLET206
68788-7733-3Aripiprazole30 in 1 BOTTLETABLET306
68788-7733-6Aripiprazole60 in 1 BOTTLETABLET606
68788-7733-9Aripiprazole90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7733-1EA - Each68788-7733fd5ba370-676c-4718-aafc-741c5eab2aa212020-09-14
68788-7733-2EA - Each68788-7733465cc9fd-d88e-4e27-b296-54337310ffdd12020-09-14
68788-7733-3EA - Each68788-77334325d173-9c6e-4c21-b883-d938f832e75712020-09-14
68788-7733-6EA - Each68788-773363a3ff3b-e9b1-42a0-848a-c342424bd41012020-09-14
68788-7733-9EA - Each68788-7733dca2c196-8b6e-4b26-82c0-464756e8980b12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7733ARIPIPRAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20250205_4894031e-639e-49d8-927a-76d684bf6655.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602964ARIPiprazole 2 MG Oral TabletPSN4894031e-639e-49d8-927a-76d684bf66556
602964aripiprazole 2 MG Oral TabletSCD4894031e-639e-49d8-927a-76d684bf66556

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7733-168788773301100 TABLET in 1 BOTTLE (68788-7733-1) 100 tablet2020-07-010000-00-00NoNoCurrent
68788-7733-26878877330220 TABLET in 1 BOTTLE (68788-7733-2) 20 tablet2020-07-010000-00-00NoNoCurrent
68788-7733-36878877330330 TABLET in 1 BOTTLE (68788-7733-3) 30 tablet2020-07-010000-00-00NoNoCurrent
68788-7733-66878877330660 TABLET in 1 BOTTLE (68788-7733-6) 60 tablet2020-07-010000-00-00NoNoCurrent
68788-7733-96878877330990 TABLET in 1 BOTTLE (68788-7733-9) 90 tablet2020-07-010000-00-00NoNoCurrent