Aripiprazole

Product NDC
82009-088
11-digit product format
820090088
Labeler code
82009
Product ID
82009-088_5c525d81-2a40-4c63-a28c-94865bf0c493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Quallent Pharmaceuticals Health LLC
Application
ANDA206174
Marketing category
ANDA
Marketing start
2023-07-19
Substance
ARIPIPRAZOLE
Active strength
2 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
ARIPIPRAZOLE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490, 349545, 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
82009-088-05Aripiprazole500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-088ARIPIPRAZOLE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC]3Current NDC, 1 package rows20250418_0e0d42ad-f4c6-4e30-adc2-ab1d122428ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN0e0d42ad-f4c6-4e30-adc2-ab1d122428ec4
349490ARIPiprazole 15 MG Oral TabletPSN0e0d42ad-f4c6-4e30-adc2-ab1d122428ec4
602964ARIPiprazole 2 MG Oral TabletPSN0e0d42ad-f4c6-4e30-adc2-ab1d122428ec4
402131ARIPiprazole 5 MG Oral TabletPSN0e0d42ad-f4c6-4e30-adc2-ab1d122428ec4
349545aripiprazole 10 MG Oral TabletSCD0e0d42ad-f4c6-4e30-adc2-ab1d122428ec4
349490aripiprazole 15 MG Oral TabletSCD0e0d42ad-f4c6-4e30-adc2-ab1d122428ec4
602964aripiprazole 2 MG Oral TabletSCD0e0d42ad-f4c6-4e30-adc2-ab1d122428ec4
402131aripiprazole 5 MG Oral TabletSCD0e0d42ad-f4c6-4e30-adc2-ab1d122428ec4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82009-088-0582009008805500 TABLET in 1 BOTTLE (82009-088-05) 500 tablet2023-07-19NoNoCurrent