FDA.reportPublic FDA data

Aripiprazole

Product NDC
27241-054
11-digit product format
272410054
Labeler code
27241
Product ID
27241-054_2a724a23-cf45-4d22-90f5-ebe68f9b7ab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA206174
Marketing category
ANDA
Marketing start
2017-05-30
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
27241-054-03Aripiprazole30 in 1 BOTTLETABLET3020
27241-054-08Aripiprazole500 in 1 BOTTLETABLET50020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-054ARIPIPRAZOLE TABLET [AJANTA PHARMA USA INC.]18Current NDC, Legacy NDC, 2 package rows20231021_d0f910b5-adef-4a93-9369-70f1ed541503.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
349490ARIPiprazole 15 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
602964ARIPiprazole 2 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
349553ARIPiprazole 20 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
349547ARIPiprazole 30 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
402131ARIPiprazole 5 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
349545aripiprazole 10 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
349490aripiprazole 15 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
602964aripiprazole 2 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
349553aripiprazole 20 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
349547aripiprazole 30 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
402131aripiprazole 5 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-054-032724100540330 TABLET in 1 BOTTLE (27241-054-03) 30 tablet2017-05-300000-00-00NoNoCurrent
27241-054-0827241005408500 TABLET in 1 BOTTLE (27241-054-08) 500 tablet2017-05-300000-00-00NoNoCurrent