FDA.reportPublic FDA data

Aripiprazole

Product NDC
71335-1893
11-digit product format
713351893
Labeler code
71335
Product ID
71335-1893_8a7f725b-ad42-4dfc-97df-ac900509f7b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205064
Marketing category
ANDA
Marketing start
2015-04-28
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
71335-1893-1Aripiprazole30 in 1 BOTTLETABLET30102
71335-1893-2Aripiprazole28 in 1 BOTTLETABLET28102
71335-1893-3Aripiprazole90 in 1 BOTTLETABLET90102
71335-1893-4Aripiprazole60 in 1 BOTTLETABLET60102
71335-1893-5Aripiprazole120 in 1 BOTTLETABLET120102
71335-1893-6Aripiprazole15 in 1 BOTTLETABLET15102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1893-4EA - Each71335-1893049279be-0659-4b1e-84c2-c5923ddc9a2a12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1893ARIPIPRAZOLE (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240412_3c0109f6-0549-4f91-a259-d9d6d7329b91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSN3c0109f6-0549-4f91-a259-d9d6d7329b91102
402131aripiprazole 5 MG Oral TabletSCD3c0109f6-0549-4f91-a259-d9d6d7329b91102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1893-17133518930130 TABLET in 1 BOTTLE (71335-1893-1) 30 tablet2021-06-300000-00-00NoNoCurrent
71335-1893-27133518930228 TABLET in 1 BOTTLE (71335-1893-2) 28 tablet2024-04-050000-00-00NoNoCurrent
71335-1893-37133518930390 TABLET in 1 BOTTLE (71335-1893-3) 90 tablet2021-07-160000-00-00NoNoCurrent
71335-1893-47133518930460 TABLET in 1 BOTTLE (71335-1893-4) 60 tablet2021-07-190000-00-00NoNoCurrent
71335-1893-571335189305120 TABLET in 1 BOTTLE (71335-1893-5) 120 tablet2024-04-050000-00-00NoNoCurrent
71335-1893-67133518930615 TABLET in 1 BOTTLE (71335-1893-6) 15 tablet2024-04-050000-00-00NoNoCurrent