FDA.reportPublic FDA data

Aripiprazole

Product NDC
71335-1682
11-digit product format
713351682
Labeler code
71335
Product ID
71335-1682_98c8e342-3362-47f2-877d-99c63bcb1727
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
2 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
ARIPIPRAZOLE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui602964

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
71335-1682-1Aripiprazole30 in 1 BOTTLETABLET308
71335-1682-2Aripiprazole28 in 1 BOTTLETABLET288
71335-1682-3Aripiprazole90 in 1 BOTTLETABLET908
71335-1682-4Aripiprazole60 in 1 BOTTLETABLET608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1682-1EA - Each71335-1682c6a30a37-ecc9-4225-9074-045a0a20025712022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1682ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 4 package rows20240410_c092a736-16e2-4dd0-8769-cb766a62f4d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602964ARIPiprazole 2 MG Oral TabletPSNc092a736-16e2-4dd0-8769-cb766a62f4d98
602964aripiprazole 2 MG Oral TabletSCDc092a736-16e2-4dd0-8769-cb766a62f4d98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1682-17133516820130 TABLET in 1 BOTTLE (71335-1682-1) 30 tablet2020-09-100000-00-00NoNoCurrent
71335-1682-27133516820228 TABLET in 1 BOTTLE (71335-1682-2) 28 tablet2024-04-040000-00-00NoNoCurrent
71335-1682-37133516820390 TABLET in 1 BOTTLE (71335-1682-3) 90 tablet2024-04-040000-00-00NoNoCurrent
71335-1682-47133516820460 TABLET in 1 BOTTLE (71335-1682-4) 60 tablet2024-04-040000-00-00NoNoCurrent