FDA.reportPublic FDA data

aripiprazole

Product NDC
71335-0412
11-digit product format
713350412
Labeler code
71335
Product ID
71335-0412_08e95ea0-2263-44d4-9b1c-49e8426bafe0
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
20 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
ARIPIPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349553

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
71335-0412-1aripiprazole30 in 1 BOTTLETABLET3015
71335-0412-2aripiprazole28 in 1 BOTTLETABLET2815
71335-0412-3aripiprazole90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0412-1EA - Each71335-0412625217a7-beb8-42aa-a469-f18390a83cef12018-03-08
71335-0412-2EA - Each71335-04122792bb04-5c36-4baa-9596-7077870f83e312018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0412ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 3 package rows20241109_e7b6a156-8001-441c-bfd3-bf8987a339e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349553ARIPiprazole 20 MG Oral TabletPSNe7b6a156-8001-441c-bfd3-bf8987a339e815
349553aripiprazole 20 MG Oral TabletSCDe7b6a156-8001-441c-bfd3-bf8987a339e815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0412-17133504120130 TABLET in 1 BOTTLE (71335-0412-1) 30 tablet2018-03-150000-00-00NoNoCurrent
71335-0412-27133504120228 TABLET in 1 BOTTLE (71335-0412-2) 28 tablet2024-10-300000-00-00NoNoCurrent
71335-0412-37133504120390 TABLET in 1 BOTTLE (71335-0412-3) 90 tablet2019-06-110000-00-00NoNoCurrent