FDA.reportPublic FDA data

Aripiprazole

Product NDC
71335-1687
11-digit product format
713351687
Labeler code
71335
Product ID
71335-1687_a684c98d-63ca-4e33-9f8f-d2ab1e3aeccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207105
Marketing category
ANDA
Marketing start
2019-02-27
Substance
ARIPIPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2027-12-31

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
71335-1687-1Aripiprazole30 in 1 BOTTLETABLET305
71335-1687-2Aripiprazole28 in 1 BOTTLETABLET285
71335-1687-3Aripiprazole90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1687-1EA - Each71335-1687d955ee3f-7bf7-42d7-b64d-fbce40404b6f12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1687ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 3 package rows20240410_4bda6f17-d87c-4009-b329-99275c56106f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349553ARIPiprazole 20 MG Oral TabletPSN4bda6f17-d87c-4009-b329-99275c56106f5
349553aripiprazole 20 MG Oral TabletSCD4bda6f17-d87c-4009-b329-99275c56106f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1687-17133516870130 TABLET in 1 BOTTLE (71335-1687-1) 30 tablet2020-08-040000-00-00NoNoCurrent
71335-1687-27133516870228 TABLET in 1 BOTTLE (71335-1687-2) 28 tablet2024-04-040000-00-00NoNoCurrent
71335-1687-37133516870390 TABLET in 1 BOTTLE (71335-1687-3) 90 tablet2024-04-040000-00-00NoNoCurrent