FDA.reportPublic FDA data

Aripiprazole

Product NDC
72865-154
11-digit product format
728650154
Labeler code
72865
Product ID
72865-154_f26f3784-b822-9efd-e053-2a95a90ab6ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA205064
Marketing category
ANDA
Marketing start
2020-11-20
Substance
ARIPIPRAZOLE
Active strength
5 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
ARIPIPRAZOLE5 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
72865-154-05Aripiprazole500 in 1 BOTTLETABLET5002
72865-154-30Aripiprazole30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-154ARIPIPRAZOLE TABLET [XLCARE PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20230117_b284b294-40a0-4ccd-b7b7-b61267cd4e76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSNb284b294-40a0-4ccd-b7b7-b61267cd4e762
349490ARIPiprazole 15 MG Oral TabletPSNb284b294-40a0-4ccd-b7b7-b61267cd4e762
602964ARIPiprazole 2 MG Oral TabletPSNb284b294-40a0-4ccd-b7b7-b61267cd4e762
349553ARIPiprazole 20 MG Oral TabletPSNb284b294-40a0-4ccd-b7b7-b61267cd4e762
349547ARIPiprazole 30 MG Oral TabletPSNb284b294-40a0-4ccd-b7b7-b61267cd4e762
402131ARIPiprazole 5 MG Oral TabletPSNb284b294-40a0-4ccd-b7b7-b61267cd4e762
349545aripiprazole 10 MG Oral TabletSCDb284b294-40a0-4ccd-b7b7-b61267cd4e762
349490aripiprazole 15 MG Oral TabletSCDb284b294-40a0-4ccd-b7b7-b61267cd4e762
602964aripiprazole 2 MG Oral TabletSCDb284b294-40a0-4ccd-b7b7-b61267cd4e762
349553aripiprazole 20 MG Oral TabletSCDb284b294-40a0-4ccd-b7b7-b61267cd4e762
349547aripiprazole 30 MG Oral TabletSCDb284b294-40a0-4ccd-b7b7-b61267cd4e762
402131aripiprazole 5 MG Oral TabletSCDb284b294-40a0-4ccd-b7b7-b61267cd4e762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72865-154-0572865015405500 TABLET in 1 BOTTLE (72865-154-05) 500 tablet2020-11-200000-00-00NoNoCurrent
72865-154-307286501543030 TABLET in 1 BOTTLE (72865-154-30) 30 tablet2020-11-200000-00-00NoNoCurrent