Aripiprazole

Product NDC
50228-330
11-digit product format
502280330
Labeler code
50228
Product ID
50228-330_26d18fe2-326d-4214-e063-6394a90a691d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole orally disintegrating
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA207240
Marketing category
ANDA
Marketing start
2018-04-18
Substance
ARIPIPRAZOLE
Active strength
10 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
ARIPIPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490, 349545

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-330-30Aripiprazole30 in 1 BOTTLETABLET307
50228-330-51Aripiprazole30 in 1 BLISTER PACKTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-330ARIPIPRAZOLE (ARIPIPRAZOLE ORALLY DISINTEGRATING) TABLET [SCIEGEN PHARMACEUTICALS INC]7Current NDC, Legacy NDC, 2 package rows20241115_4bcfd5a7-bec7-4426-9314-17daaf715cad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN4bcfd5a7-bec7-4426-9314-17daaf715cad7
349490ARIPiprazole 15 MG Oral TabletPSN4bcfd5a7-bec7-4426-9314-17daaf715cad7
349545aripiprazole 10 MG Oral TabletSCD4bcfd5a7-bec7-4426-9314-17daaf715cad7
349490aripiprazole 15 MG Oral TabletSCD4bcfd5a7-bec7-4426-9314-17daaf715cad7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-330-305022803303030 TABLET in 1 BOTTLE (50228-330-30) 30 tablet2018-04-180000-00-00NoNoCurrent
50228-330-515022803305130 TABLET in 1 BLISTER PACK (50228-330-51) 30 tablet2018-04-180000-00-00NoNoCurrent