Aripiprazole

Product NDC
60505-2673
11-digit product format
605052673
Labeler code
60505
Product ID
60505-2673_2a711e92-f48e-998e-f328-449ccf7d0dcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp
Application
ANDA078583
Marketing category
ANDA
Marketing start
2015-07-24
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2673-3EA - Each60505-2673c38c5677-02c7-4595-99d0-850d6a02cecb12015-08-04
60505-2673-8EA - Each60505-2673bc996c53-727d-4884-97c8-23cdac04ee7912017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AripiprazoleACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE TABLET [APOTEX CORP]2
AripiprazoleACTIVE MOIETY82VFR53I78ARIPIPRAZOLE TABLET [APOTEX CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARIPIPRAZOLE TABLET [APOTEX CORP]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48ARIPIPRAZOLE TABLET [APOTEX CORP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKARIPIPRAZOLE TABLET [APOTEX CORP]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ARIPIPRAZOLE TABLET [APOTEX CORP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARIPIPRAZOLE TABLET [APOTEX CORP]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30ARIPIPRAZOLE TABLET [APOTEX CORP]2
Tartaric AcidINACTIVE INGREDIENTW4888I119HARIPIPRAZOLE TABLET [APOTEX CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2673ARIPIPRAZOLE TABLET [APOTEX CORP]18Legacy NDC20250321_569f1c32-fb6f-c34f-0894-4b1e7b744a8a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2673-36050526730330 TABLET in 1 BOTTLE (60505-2673-3) 30 tablet2015-07-240000-00-00NoNoCurrent
60505-2673-8605052673081000 TABLET in 1 BOTTLE (60505-2673-8) 1000 tablet2015-07-240000-00-00NoNoCurrent