Aripiprazole

Product NDC
72888-100
11-digit product format
728880100
Labeler code
72888
Product ID
72888-100_44f33ff5-ea1d-b6b6-e063-6394a90a40c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
SOLUTION
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA216351
Marketing category
ANDA
Marketing start
2022-10-27
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
72888-100-20Aripiprazole1 in 1 CARTONSOLUTION15
72888-100-20Aripiprazole150 mL in 1 BOTTLESOLUTION1505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-100-20ML - Milliliter72888-10013249f31-074d-4ced-86a2-5a7f49ec283012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-100ARIPIPRAZOLE SOLUTION [ADVAGEN PHARMA LTD]3Current NDC, Legacy NDC, 2 package rows20231228_4537e26b-dcf8-4a78-ab7d-57359b1d2192.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSN4537e26b-dcf8-4a78-ab7d-57359b1d21925
485496aripiprazole 1 MG/ML Oral SolutionSCD4537e26b-dcf8-4a78-ab7d-57359b1d21925
485496aripiprazole 1 MG per 1 ML Oral SolutionSY4537e26b-dcf8-4a78-ab7d-57359b1d21925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72888-100-20728880100201 BOTTLE in 1 CARTON (72888-100-20) / 150 mL in 1 BOTTLE1 bottle2022-10-270000-00-00NoNoCurrent