FDA.reportPublic FDA data

Aripiprazole

Product NDC
50228-477
11-digit product format
502280477
Labeler code
50228
Product ID
50228-477_f52587a6-f60d-515d-e053-2995a90aadb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA206383
Marketing category
ANDA
Marketing start
2020-02-25
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, 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
50228-477-10Aripiprazole1000 in 1 BOTTLETABLET10002
50228-477-30Aripiprazole30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-477ARIPIPRAZOLE TABLET [SCIEGEN PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 2 package rows20230222_a7d9d5d1-25ba-4f4e-a990-398c0bf09c7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSNa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
349490ARIPiprazole 15 MG Oral TabletPSNa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
602964ARIPiprazole 2 MG Oral TabletPSNa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
349553ARIPiprazole 20 MG Oral TabletPSNa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
349547ARIPiprazole 30 MG Oral TabletPSNa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
402131ARIPiprazole 5 MG Oral TabletPSNa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
349545aripiprazole 10 MG Oral TabletSCDa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
349490aripiprazole 15 MG Oral TabletSCDa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
602964aripiprazole 2 MG Oral TabletSCDa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
349553aripiprazole 20 MG Oral TabletSCDa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
349547aripiprazole 30 MG Oral TabletSCDa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2
402131aripiprazole 5 MG Oral TabletSCDa7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-477-10502280477101000 TABLET in 1 BOTTLE (50228-477-10) 1000 tablet2020-02-250000-00-00NoNoCurrent
50228-477-305022804773030 TABLET in 1 BOTTLE (50228-477-30) 30 tablet2020-02-250000-00-00NoNoCurrent