FDA.reportPublic FDA data

Aripiprazole

Product NDC
71335-1513
11-digit product format
713351513
Labeler code
71335
Product ID
71335-1513_cfe7a124-6d12-426a-873f-eb583a8decc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206174
Marketing category
ANDA
Marketing start
2017-05-30
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
71335-1513-1Aripiprazole30 in 1 BOTTLETABLET307
71335-1513-2Aripiprazole28 in 1 BOTTLETABLET287
71335-1513-3Aripiprazole90 in 1 BOTTLETABLET907
71335-1513-4Aripiprazole60 in 1 BOTTLETABLET607
71335-1513-5Aripiprazole120 in 1 BOTTLETABLET1207
71335-1513-6Aripiprazole15 in 1 BOTTLETABLET157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1513-1EA - Each71335-15135ea90f13-f0d4-4b77-9025-b5a4ebe71a5a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1513ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 6 package rows20231123_fd2fa4da-2ee9-4965-b1f8-ce1c8b73ba93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSNfd2fa4da-2ee9-4965-b1f8-ce1c8b73ba937
402131aripiprazole 5 MG Oral TabletSCDfd2fa4da-2ee9-4965-b1f8-ce1c8b73ba937

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1513-17133515130130 TABLET in 1 BOTTLE (71335-1513-1) 30 tablet2020-02-200000-00-00NoNoCurrent
71335-1513-27133515130228 TABLET in 1 BOTTLE (71335-1513-2) 28 tablet2022-02-140000-00-00NoNoCurrent
71335-1513-37133515130390 TABLET in 1 BOTTLE (71335-1513-3) 90 tablet2022-02-140000-00-00NoNoCurrent
71335-1513-47133515130460 TABLET in 1 BOTTLE (71335-1513-4) 60 tablet2022-02-140000-00-00NoNoCurrent
71335-1513-571335151305120 TABLET in 1 BOTTLE (71335-1513-5) 120 tablet2022-02-140000-00-00NoNoCurrent
71335-1513-67133515130615 TABLET in 1 BOTTLE (71335-1513-6) 15 tablet2022-02-140000-00-00NoNoCurrent