Aripiprazole

Product NDC
69452-338
11-digit product format
694520338
Labeler code
69452
Product ID
69452-338_a104bd7b-2748-450c-b4d3-9e96ccf2939d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA202547
Marketing category
ANDA
Marketing start
2022-02-07
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
Rxcui643019, 643022

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
69452-338-13Aripiprazole30 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-338ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING [BIONPHARMA INC.]6Current NDC, Legacy NDC, 1 package rows20250121_720bc395-777d-4e5d-9571-aad5827dbf6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
643019ARIPiprazole 10 MG Disintegrating Oral TabletPSN720bc395-777d-4e5d-9571-aad5827dbf6d6
643022ARIPiprazole 15 MG Disintegrating Oral TabletPSN720bc395-777d-4e5d-9571-aad5827dbf6d6
643019aripiprazole 10 MG Disintegrating Oral TabletSCD720bc395-777d-4e5d-9571-aad5827dbf6d6
643022aripiprazole 15 MG Disintegrating Oral TabletSCD720bc395-777d-4e5d-9571-aad5827dbf6d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-338-136945203381330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-338-13) 2022-02-070000-00-00NoNoCurrent