FDA.reportPublic FDA data

Aripiprazole

Product NDC
76282-046
11-digit product format
762820046
Labeler code
76282
Product ID
76282-046_ae9e2824-8741-4973-b349-a18ce05cb334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA205064
Marketing category
ANDA
Marketing start
2015-04-28
Substance
ARIPIPRAZOLE
Active strength
10 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
ARIPIPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490, 349545, 349547, 349553, 402131, 602964

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
76282-046-01Aripiprazole100 in 1 BOTTLETABLET1002
76282-046-30Aripiprazole30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-046-30EA - Each76282-04649e467bb-c189-4da5-8480-1c04659e671312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-046ARIPIPRAZOLE TABLET [EXELAN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20181229_705190bf-9f9d-4183-a56b-4eeafeacde59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN705190bf-9f9d-4183-a56b-4eeafeacde592
349490ARIPiprazole 15 MG Oral TabletPSN705190bf-9f9d-4183-a56b-4eeafeacde592
602964ARIPiprazole 2 MG Oral TabletPSN705190bf-9f9d-4183-a56b-4eeafeacde592
349553ARIPiprazole 20 MG Oral TabletPSN705190bf-9f9d-4183-a56b-4eeafeacde592
349547ARIPiprazole 30 MG Oral TabletPSN705190bf-9f9d-4183-a56b-4eeafeacde592
402131ARIPiprazole 5 MG Oral TabletPSN705190bf-9f9d-4183-a56b-4eeafeacde592
349545aripiprazole 10 MG Oral TabletSCD705190bf-9f9d-4183-a56b-4eeafeacde592
349490aripiprazole 15 MG Oral TabletSCD705190bf-9f9d-4183-a56b-4eeafeacde592
602964aripiprazole 2 MG Oral TabletSCD705190bf-9f9d-4183-a56b-4eeafeacde592
349553aripiprazole 20 MG Oral TabletSCD705190bf-9f9d-4183-a56b-4eeafeacde592
349547aripiprazole 30 MG Oral TabletSCD705190bf-9f9d-4183-a56b-4eeafeacde592
402131aripiprazole 5 MG Oral TabletSCD705190bf-9f9d-4183-a56b-4eeafeacde592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-046-0176282004601100 TABLET in 1 BOTTLE (76282-046-01) 100 tablet2016-10-070000-00-00NoNoCurrent
76282-046-307628200463030 TABLET in 1 BOTTLE (76282-046-30) 30 tablet2016-10-070000-00-00NoNoCurrent