FDA.reportPublic FDA data

Aripiprazole

Product NDC
71335-1935
11-digit product format
713351935
Labeler code
71335
Product ID
71335-1935_565dd1b2-149c-4475-abac-65d6aa107f94
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
15 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
ARIPIPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490

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
71335-1935-1Aripiprazole30 in 1 BOTTLETABLET30104
71335-1935-2Aripiprazole15 in 1 BOTTLETABLET15104
71335-1935-3Aripiprazole28 in 1 BOTTLETABLET28104
71335-1935-4Aripiprazole60 in 1 BOTTLETABLET60104
71335-1935-5Aripiprazole90 in 1 BOTTLETABLET90104
71335-1935-6Aripiprazole120 in 1 BOTTLETABLET120104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1935ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240415_1ef9e44f-5672-47c2-97e9-286e1b84417d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349490ARIPiprazole 15 MG Oral TabletPSN1ef9e44f-5672-47c2-97e9-286e1b84417d104
349490aripiprazole 15 MG Oral TabletSCD1ef9e44f-5672-47c2-97e9-286e1b84417d104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1935-17133519350130 TABLET in 1 BOTTLE (71335-1935-1) 30 tablet2021-08-240000-00-00NoNoCurrent
71335-1935-27133519350215 TABLET in 1 BOTTLE (71335-1935-2) 15 tablet2024-04-080000-00-00NoNoCurrent
71335-1935-37133519350328 TABLET in 1 BOTTLE (71335-1935-3) 28 tablet2024-04-080000-00-00NoNoCurrent
71335-1935-47133519350460 TABLET in 1 BOTTLE (71335-1935-4) 60 tablet2024-04-080000-00-00NoNoCurrent
71335-1935-57133519350590 TABLET in 1 BOTTLE (71335-1935-5) 90 tablet2022-01-270000-00-00NoNoCurrent
71335-1935-671335193506120 TABLET in 1 BOTTLE (71335-1935-6) 120 tablet2024-04-080000-00-00NoNoCurrent