Aripiprazole

Product NDC
72603-445
11-digit product format
726030445
Labeler code
72603
Product ID
72603-445_15449fee-e073-7129-e063-6294a90a3538
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole oral
Dosage form
SOLUTION
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA216150
Marketing category
ANDA
Marketing start
2024-05-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-445-01Aripiprazole1 in 1 CARTONSOLUTION11
72603-445-01Aripiprazole150 mL in 1 BOTTLESOLUTION1501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-445-01ML - Milliliter72603-445e714500a-0d01-4279-b596-d6dfbac5f79512024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-445ARIPIPRAZOLE (ARIPIPRAZOLE ORAL) SOLUTION [NORTHSTAR RXLLC]1Current NDC, 2 package rows20240501_4a0a2f6c-d7bb-48d1-b5ca-066f27f78e41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSN4a0a2f6c-d7bb-48d1-b5ca-066f27f78e411
485496aripiprazole 1 MG/ML Oral SolutionSCD4a0a2f6c-d7bb-48d1-b5ca-066f27f78e411
485496aripiprazole 1 MG per 1 ML Oral SolutionSY4a0a2f6c-d7bb-48d1-b5ca-066f27f78e411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-445-01726030445011 BOTTLE in 1 CARTON (72603-445-01) / 150 mL in 1 BOTTLE1 bottle2024-05-01NoNoCurrent