Aripiprazole

Product NDC
65162-902
11-digit product format
651620902
Labeler code
65162
Product ID
65162-902_c125d854-8bb2-4467-83b4-c8a0e0f893c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204838
Marketing category
ANDA
Marketing start
2016-06-20
Substance
ARIPIPRAZOLE
Active strength
30 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
ARIPIPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490, 349545, 349547, 349553, 402131, 602964

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
65162-902-03Aripiprazole30 in 1 BOTTLETABLET3025
65162-902-09Aripiprazole90 in 1 BOTTLETABLET9025
65162-902-11Aripiprazole1000 in 1 BOTTLETABLET100025
65162-902-50Aripiprazole500 in 1 BOTTLETABLET50025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-902ARIPIPRAZOLE TABLET [AMNEAL PHARMACEUTICALS LLC]24Current NDC, Legacy NDC, 4 package rows20250416_06dda03f-8481-46d6-af02-4f51e1a3a065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
349490ARIPiprazole 15 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
602964ARIPiprazole 2 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
349553ARIPiprazole 20 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
349547ARIPiprazole 30 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
402131ARIPiprazole 5 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
349545aripiprazole 10 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
349490aripiprazole 15 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
602964aripiprazole 2 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
349553aripiprazole 20 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
349547aripiprazole 30 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
402131aripiprazole 5 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
349547ARIPiprazole 30 MG Oral TabletPSN96172aa4-9e13-4eca-83d5-85a88c1782d36
349547aripiprazole 30 MG Oral TabletSCD96172aa4-9e13-4eca-83d5-85a88c1782d36
349545ARIPiprazole 10 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
349490ARIPiprazole 15 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
602964ARIPiprazole 2 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
349553ARIPiprazole 20 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
349547ARIPiprazole 30 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
402131ARIPiprazole 5 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
349545aripiprazole 10 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
349490aripiprazole 15 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
602964aripiprazole 2 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
349553aripiprazole 20 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
349547aripiprazole 30 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
402131aripiprazole 5 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-902-036516209020330 TABLET in 1 BOTTLE (65162-902-03) 30 tablet2016-06-200000-00-00NoNoCurrent
65162-902-096516209020990 TABLET in 1 BOTTLE (65162-902-09) 90 tablet2016-06-200000-00-00NoNoCurrent
65162-902-11651620902111000 TABLET in 1 BOTTLE (65162-902-11) 1000 tablet2016-06-200000-00-00NoNoCurrent
65162-902-5065162090250500 TABLET in 1 BOTTLE (65162-902-50) 500 tablet2016-06-200000-00-00NoNoCurrent