FDA.reportPublic FDA data

ABILIFY

Product NDC
21695-004
11-digit product format
216950004
Labeler code
21695
Product ID
21695-004_217e52b5-3a7b-4bbe-af3c-b18de7d426c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
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
21695-004-152019-09-24C16284748780-1934fe258-4902-48b1-e053-8cdaa90a720aThese 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
21695-004-15ABILIFY15 in 1 BOTTLE, PLASTICTABLET151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-004-15EA - Each21695-004c2997c25-b333-4d9d-ae13-b3d90b4ec38812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-004ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100907_217e52b5-3a7b-4bbe-af3c-b18de7d426c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352307ABILIFY 10 MG Oral TabletPSN217e52b5-3a7b-4bbe-af3c-b18de7d426c31
352308ABILIFY 15 MG Oral TabletPSN217e52b5-3a7b-4bbe-af3c-b18de7d426c31
352309ABILIFY 20 MG Oral TabletPSN217e52b5-3a7b-4bbe-af3c-b18de7d426c31
404602ABILIFY 5 MG Oral TabletPSN217e52b5-3a7b-4bbe-af3c-b18de7d426c31
349545ARIPiprazole 10 MG Oral TabletPSN217e52b5-3a7b-4bbe-af3c-b18de7d426c31
349490ARIPiprazole 15 MG Oral TabletPSN217e52b5-3a7b-4bbe-af3c-b18de7d426c31
349553ARIPiprazole 20 MG Oral TabletPSN217e52b5-3a7b-4bbe-af3c-b18de7d426c31
402131ARIPiprazole 5 MG Oral TabletPSN217e52b5-3a7b-4bbe-af3c-b18de7d426c31
352307aripiprazole 10 MG Oral Tablet [Abilify]SBD217e52b5-3a7b-4bbe-af3c-b18de7d426c31
352308aripiprazole 15 MG Oral Tablet [Abilify]SBD217e52b5-3a7b-4bbe-af3c-b18de7d426c31
352309aripiprazole 20 MG Oral Tablet [Abilify]SBD217e52b5-3a7b-4bbe-af3c-b18de7d426c31
404602aripiprazole 5 MG Oral Tablet [Abilify]SBD217e52b5-3a7b-4bbe-af3c-b18de7d426c31
349545aripiprazole 10 MG Oral TabletSCD217e52b5-3a7b-4bbe-af3c-b18de7d426c31
349490aripiprazole 15 MG Oral TabletSCD217e52b5-3a7b-4bbe-af3c-b18de7d426c31
349553aripiprazole 20 MG Oral TabletSCD217e52b5-3a7b-4bbe-af3c-b18de7d426c31
402131aripiprazole 5 MG Oral TabletSCD217e52b5-3a7b-4bbe-af3c-b18de7d426c31
352307Abilify 10 MG Oral TabletSY217e52b5-3a7b-4bbe-af3c-b18de7d426c31
352308Abilify 15 MG Oral TabletSY217e52b5-3a7b-4bbe-af3c-b18de7d426c31
352309Abilify 20 MG Oral TabletSY217e52b5-3a7b-4bbe-af3c-b18de7d426c31
404602Abilify 5 MG Oral TabletSY217e52b5-3a7b-4bbe-af3c-b18de7d426c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-004-152169500041515 in 1 BOTTLE, PLASTICHistorical