FDA.reportPublic FDA data

aripiprazole

Product NDC
63629-7108
11-digit product format
636297108
Labeler code
63629
Product ID
63629-7108_81f5b16d-263b-4450-99f4-3405aa565e2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201519
Marketing category
ANDA
Marketing start
2015-04-28
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

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
63629-7108-1aripiprazole30 in 1 BOTTLETABLET30106
63629-7108-2aripiprazole15 in 1 BOTTLETABLET15106
63629-7108-3aripiprazole28 in 1 BOTTLETABLET28106
63629-7108-4aripiprazole60 in 1 BOTTLETABLET60106
63629-7108-5aripiprazole90 in 1 BOTTLETABLET90106
63629-7108-6aripiprazole120 in 1 BOTTLETABLET120106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7108-1EA - Each63629-7108b6a8a8fc-c911-48bd-bbd6-082a49544f8a12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7108ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 6 package rows20241109_d130836c-5f1c-4779-ac6c-6350752dc015.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349490ARIPiprazole 15 MG Oral TabletPSNd130836c-5f1c-4779-ac6c-6350752dc015106
349490aripiprazole 15 MG Oral TabletSCDd130836c-5f1c-4779-ac6c-6350752dc015106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7108-16362971080130 TABLET in 1 BOTTLE (63629-7108-1) 30 tablet2016-09-290000-00-00NoNoCurrent
63629-7108-26362971080215 TABLET in 1 BOTTLE (63629-7108-2) 15 tablet2024-10-290000-00-00NoNoCurrent
63629-7108-36362971080328 TABLET in 1 BOTTLE (63629-7108-3) 28 tablet2024-10-290000-00-00NoNoCurrent
63629-7108-46362971080460 TABLET in 1 BOTTLE (63629-7108-4) 60 tablet2018-06-040000-00-00NoNoCurrent
63629-7108-56362971080590 TABLET in 1 BOTTLE (63629-7108-5) 90 tablet2024-10-290000-00-00NoNoCurrent
63629-7108-663629710806120 TABLET in 1 BOTTLE (63629-7108-6) 120 tablet2024-10-290000-00-00NoNoCurrent