FDA.reportPublic FDA data

Aripiprazole

Product NDC
65862-664
11-digit product format
658620664
Labeler code
65862
Product ID
65862-664_9f7087f5-c8ef-4c1f-9a25-228ed3149b01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203908
Marketing category
ANDA
Marketing start
2015-10-08
Substance
ARIPIPRAZOLE
Active strength
15 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
ARIPIPRAZOLE15 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
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
65862-664-01Aripiprazole100 in 1 BOTTLETABLET10017
65862-664-05Aripiprazole500 in 1 BOTTLETABLET50017
65862-664-10Aripiprazole10 in 1 BLISTER PACKTABLET1017
65862-664-30Aripiprazole30 in 1 BOTTLETABLET3017
65862-664-78Aripiprazole10 in 1 CARTONTABLET1017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-664-05EA - Each65862-664483a1807-7e52-4cfe-9cca-b76ac11bb7bf12016-03-04
65862-664-30EA - Each65862-664861ba92b-8ff1-4137-b2de-9b92fcbb951812015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-664ARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 5 package rows20250326_7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
349490ARIPiprazole 15 MG Oral TabletPSN7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
602964ARIPiprazole 2 MG Oral TabletPSN7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
349553ARIPiprazole 20 MG Oral TabletPSN7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
349547ARIPiprazole 30 MG Oral TabletPSN7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
402131ARIPiprazole 5 MG Oral TabletPSN7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
349545aripiprazole 10 MG Oral TabletSCD7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
349490aripiprazole 15 MG Oral TabletSCD7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
602964aripiprazole 2 MG Oral TabletSCD7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
349553aripiprazole 20 MG Oral TabletSCD7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
349547aripiprazole 30 MG Oral TabletSCD7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17
402131aripiprazole 5 MG Oral TabletSCD7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-664-0165862066401100 TABLET in 1 BOTTLE (65862-664-01) 100 tablet2015-10-080000-00-00NoNoCurrent
65862-664-0565862066405500 TABLET in 1 BOTTLE (65862-664-05) 500 tablet2015-10-080000-00-00NoNoCurrent
65862-664-106586206641010 in 1 BLISTER PACKHistorical
65862-664-306586206643030 TABLET in 1 BOTTLE (65862-664-30) 30 tablet2015-10-080000-00-00NoNoCurrent
65862-664-786586206647810 BLISTER PACK in 1 CARTON (65862-664-78) / 10 TABLET in 1 BLISTER PACK (65862-664-10) 10 blister pack2015-10-080000-00-00NoNoCurrent