Aripiprazole

Product NDC
0615-8375
11-digit product format
006158375
Labeler code
0615
Product ID
0615-8375_e8de660c-3ea9-489c-aca4-8b7c6e3f428f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA206383
Marketing category
ANDA
Marketing start
2020-03-16
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
Rxcui402131

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
0615-8375-39Aripiprazole30 in 1 BLISTER PACKTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8375ARIPIPRAZOLE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]3Current NDC, Legacy NDC, 1 package rows20220804_8da99c93-613e-4b78-9f91-3efc2dea194d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSN8da99c93-613e-4b78-9f91-3efc2dea194d3
402131aripiprazole 5 MG Oral TabletSCD8da99c93-613e-4b78-9f91-3efc2dea194d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8375-390061583753930 TABLET in 1 BLISTER PACK (0615-8375-39) 30 tablet2021-02-030000-00-00NoNoCurrent