FDA.reportPublic FDA data

aripiprazole

Product NDC
60505-0404
11-digit product format
605050404
Labeler code
60505
Product ID
60505-0404_30d65f6a-6da1-4ba2-2eb3-339c2f54a735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
SOLUTION
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA204094
Marketing category
ANDA
Marketing start
2015-10-08
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
60505-0404-5aripiprazole150 mL in 1 BOTTLESOLUTION15016
60505-0404-5aripiprazole1 in 1 CARTONSOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0404-5ML - Milliliter60505-0404555da0fa-3d00-4fbf-8cf6-ca3905a7109a12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
Malic AcidINACTIVE INGREDIENT817L1N4CKPARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
OrangeINACTIVE INGREDIENT5EVU04N5QUARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
SUCROSEINACTIVE INGREDIENTC151H8M554ARIPIPRAZOLE SOLUTION [APOTEX CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RARIPIPRAZOLE SOLUTION [APOTEX CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0404ARIPIPRAZOLE SOLUTION [APOTEX CORP.]15Current NDC, Legacy NDC, 2 package rows20250412_14910dae-da81-3d73-d0a4-e98d13917c69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSN14910dae-da81-3d73-d0a4-e98d13917c6916
485496aripiprazole 1 MG/ML Oral SolutionSCD14910dae-da81-3d73-d0a4-e98d13917c6916
485496aripiprazole 1 MG per 1 ML Oral SolutionSY14910dae-da81-3d73-d0a4-e98d13917c6916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0404-5605050404051 BOTTLE in 1 CARTON (60505-0404-5) / 150 mL in 1 BOTTLE1 bottle2015-10-080000-00-00NoNoCurrent