FDA.reportPublic FDA data

ABILIFY

Product NDC
68151-4461
11-digit product format
681514461
Labeler code
68151
Product ID
68151-4461_b3adc362-236f-4fb1-b266-17944296d4c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
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
2018-12-31
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
68151-4461-12020-01-31C16284748780-19d75b9d0-cfc7-f424-e053-dadaa90a57ceThese 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
68151-4461-1ABILIFY1 in 1 PACKAGETABLET13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4461ABILIFY (ARIPIPRAZOLE) TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_f9648990-0627-4c66-aae1-d3eef398b5b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352308ABILIFY 15 MG Oral TabletPSNf9648990-0627-4c66-aae1-d3eef398b5b43
349490ARIPiprazole 15 MG Oral TabletPSNf9648990-0627-4c66-aae1-d3eef398b5b43
352308aripiprazole 15 MG Oral Tablet [Abilify]SBDf9648990-0627-4c66-aae1-d3eef398b5b43
349490aripiprazole 15 MG Oral TabletSCDf9648990-0627-4c66-aae1-d3eef398b5b43
352308Abilify 15 MG Oral TabletSYf9648990-0627-4c66-aae1-d3eef398b5b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4461-1681514461011 in 1 PACKAGEHistorical