FDA.reportPublic FDA data

Aripiprazole

Product NDC
71335-1832
11-digit product format
713351832
Labeler code
71335
Product ID
71335-1832_f43ca26f-40f6-45da-a0b1-1ee42eee6962
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
5 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
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
71335-1832-1Aripiprazole30 in 1 BOTTLETABLET30107
71335-1832-2Aripiprazole28 in 1 BOTTLETABLET28107
71335-1832-3Aripiprazole90 in 1 BOTTLETABLET90107
71335-1832-4Aripiprazole60 in 1 BOTTLETABLET60107
71335-1832-5Aripiprazole120 in 1 BOTTLETABLET120107
71335-1832-6Aripiprazole15 in 1 BOTTLETABLET15107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1832ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 6 package rows20240608_fb40b669-4e37-4087-8fb1-3ac140543602.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSNfb40b669-4e37-4087-8fb1-3ac140543602107
402131aripiprazole 5 MG Oral TabletSCDfb40b669-4e37-4087-8fb1-3ac140543602107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1832-17133518320130 TABLET in 1 BOTTLE (71335-1832-1) 30 tablet2021-04-290000-00-00NoNoCurrent
71335-1832-27133518320228 TABLET in 1 BOTTLE (71335-1832-2) 28 tablet2022-05-030000-00-00NoNoCurrent
71335-1832-37133518320390 TABLET in 1 BOTTLE (71335-1832-3) 90 tablet2021-06-240000-00-00NoNoCurrent
71335-1832-47133518320460 TABLET in 1 BOTTLE (71335-1832-4) 60 tablet2021-06-010000-00-00NoNoCurrent
71335-1832-571335183205120 TABLET in 1 BOTTLE (71335-1832-5) 120 tablet2022-05-030000-00-00NoNoCurrent
71335-1832-67133518320615 TABLET in 1 BOTTLE (71335-1832-6) 15 tablet2022-05-030000-00-00NoNoCurrent