FDA.reportPublic FDA data

Aripiprazole

Product NDC
76483-103
11-digit product format
764830103
Labeler code
76483
Product ID
76483-103_d7622fbb-a43c-46db-bde4-d05ed7bff185
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
SQUARE PHARMACEUTICALS LIMITED
Application
ANDA090165
Marketing category
ANDA
Marketing start
2022-07-20
Substance
ARIPIPRAZOLE
Active strength
30 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
ARIPIPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui643019, 643022, 643027, 643058

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76483-103-00Aripiprazole30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING303
76483-103-01Aripiprazole60 in 1 BOTTLETABLET, ORALLY DISINTEGRATING603
76483-103-02Aripiprazole90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING903
76483-103-03Aripiprazole120 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1203
76483-103-04Aripiprazole30 in 1 CARTONTABLET, ORALLY DISINTEGRATING303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76483-103ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING [SQUARE PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 5 package rows20230706_0f9b1fd8-a648-45c9-8655-14de07439f34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
643019ARIPiprazole 10 MG Disintegrating Oral TabletPSN0f9b1fd8-a648-45c9-8655-14de07439f343
643022ARIPiprazole 15 MG Disintegrating Oral TabletPSN0f9b1fd8-a648-45c9-8655-14de07439f343
643027ARIPiprazole 20 MG Disintegrating Oral TabletPSN0f9b1fd8-a648-45c9-8655-14de07439f343
643058ARIPiprazole 30 MG Disintegrating Oral TabletPSN0f9b1fd8-a648-45c9-8655-14de07439f343
643019aripiprazole 10 MG Disintegrating Oral TabletSCD0f9b1fd8-a648-45c9-8655-14de07439f343
643022aripiprazole 15 MG Disintegrating Oral TabletSCD0f9b1fd8-a648-45c9-8655-14de07439f343
643027aripiprazole 20 MG Disintegrating Oral TabletSCD0f9b1fd8-a648-45c9-8655-14de07439f343
643058aripiprazole 30 MG Disintegrating Oral TabletSCD0f9b1fd8-a648-45c9-8655-14de07439f343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76483-103-007648301030030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-103-00) 2022-07-200000-00-00NoNoCurrent
76483-103-017648301030160 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-103-01) 2022-07-200000-00-00NoNoCurrent
76483-103-027648301030290 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-103-02) 2022-07-200000-00-00NoNoCurrent
76483-103-0376483010303120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-103-03) 2022-07-200000-00-00NoNoCurrent
76483-103-047648301030430 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-103-04) 2023-02-22NoNoCurrent