FDA.reportPublic FDA data

ABILIFY

Product NDC
64725-0009
11-digit product format
647250009
Labeler code
64725
Product ID
64725-0009_1c1e7873-4fbf-4033-94d7-9fd8416b828e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
NDA021436
Marketing category
NDA
Marketing start
2002-11-15
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0009-12019-11-27C16284748780-19855e2a2-3fcc-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY (aripiprazole) Tablets ABILIFY DISCMELT (aripiprazole) Orally Disintegrating Tablets ABILIFY (aripiprazole) Oral Solution ABILIFY (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002 ® ® ® ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0009-1ABILIFY30 in 1 BOTTLETABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0009ABILIFY (ARIPIPRAZOLE) TABLET [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140828_d0640208-44e9-4052-a56f-9a4cd9a5aaab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352308ABILIFY 15 MG Oral TabletPSNd0640208-44e9-4052-a56f-9a4cd9a5aaab2
349490ARIPiprazole 15 MG Oral TabletPSNd0640208-44e9-4052-a56f-9a4cd9a5aaab2
352308aripiprazole 15 MG Oral Tablet [Abilify]SBDd0640208-44e9-4052-a56f-9a4cd9a5aaab2
349490aripiprazole 15 MG Oral TabletSCDd0640208-44e9-4052-a56f-9a4cd9a5aaab2
352308Abilify 15 MG Oral TabletSYd0640208-44e9-4052-a56f-9a4cd9a5aaab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0009-16472500090130 in 1 BOTTLEHistorical