Aripiprazole

Product NDC
59651-110
11-digit product format
596510110
Labeler code
59651
Product ID
59651-110_335e176d-01fe-4b63-9e9f-1bdf95c3ae70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA210479
Marketing category
ANDA
Marketing start
2019-01-29
Substance
ARIPIPRAZOLE
Active strength
1 mg/mL
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
ARIPIPRAZOLE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui485496

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-110-55Aripiprazole150 mL in 1 BOTTLESOLUTION15013
59651-110-55Aripiprazole1 in 1 CARTONSOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-110-55ML - Milliliter59651-110bc2a6600-6bcf-48e5-963a-6ad41461387712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-110ARIPIPRAZOLE SOLUTION [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 2 package rows20241012_fcabd777-dcb7-452c-821c-575a5991c90a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSNfcabd777-dcb7-452c-821c-575a5991c90a13
485496aripiprazole 1 MG/ML Oral SolutionSCDfcabd777-dcb7-452c-821c-575a5991c90a13
485496aripiprazole 1 MG per 1 ML Oral SolutionSYfcabd777-dcb7-452c-821c-575a5991c90a13
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSN48d8b880-ed1c-425a-88ef-75289d51e1262
485496aripiprazole 1 MG/ML Oral SolutionSCD48d8b880-ed1c-425a-88ef-75289d51e1262
485496aripiprazole 1 MG per 1 ML Oral SolutionSY48d8b880-ed1c-425a-88ef-75289d51e1262

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-110-55596510110551 BOTTLE in 1 CARTON (59651-110-55) / 150 mL in 1 BOTTLE1 bottle2019-01-290000-00-00NoNoCurrent