FDA.reportPublic FDA data

ABILIFY

Product NDC
52959-604
11-digit product format
529590604
Labeler code
52959
Product ID
52959-604_5faa9dae-bc3e-4a04-8909-94d8133f8e53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA021436
Marketing category
NDA
Marketing start
2002-11-15
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-604IInactivated by FDA2026-07-31
excluded packagepackage52959-60452959-604-30IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021436-001ABILIFYARIPIPRAZOLE10MGTABLET / ORALABRLD, RS2002-11-15
N021436-002ABILIFYARIPIPRAZOLE15MGTABLET / ORALABRLD2002-11-15
N021436-003ABILIFYARIPIPRAZOLE20MGTABLET / ORALABRLD2002-11-15
N021436-004ABILIFYARIPIPRAZOLE30MGTABLET / ORALABRLD2002-11-15
N021436-005ABILIFYARIPIPRAZOLE5MGTABLET / ORALABRLD2002-11-15
N021436-006ABILIFYARIPIPRAZOLE2MGTABLET / ORALABRLD2002-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N021436-001AB
N021436-002AB
N021436-003AB
N021436-004AB
N021436-005AB
N021436-006AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021436-00191259392026-07-28U-17492015-10-07
N021436-00187593502027-03-02U-15292014-07-22
N021436-00291259392026-07-28U-17492015-10-07
N021436-00287593502027-03-02U-15292014-07-22
N021436-00391259392026-07-28U-17492015-10-07
N021436-00387593502027-03-02U-15292014-07-22
N021436-00491259392026-07-28U-17492015-10-07
N021436-00487593502027-03-02U-15292014-07-22
N021436-00591259392026-07-28U-17492015-10-07
N021436-00587593502027-03-02U-15292014-07-22
N021436-00691259392026-07-28U-17492015-10-07
N021436-00687593502027-03-02U-15292014-07-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021436-001ABILIFY10MGTABLET / ORALABRLD, RS2002-11-15a50c72e98297…
2026-08-01 22:54:322026-06N021436-002ABILIFY15MGTABLET / ORALABRLD2002-11-15a50c72e98297…
2026-08-01 22:54:322026-06N021436-003ABILIFY20MGTABLET / ORALABRLD2002-11-15a50c72e98297…
2026-08-01 22:54:322026-06N021436-004ABILIFY30MGTABLET / ORALABRLD2002-11-15a50c72e98297…
2026-08-01 22:54:322026-06N021436-005ABILIFY5MGTABLET / ORALABRLD2002-11-15a50c72e98297…
2026-08-01 22:54:322026-06N021436-006ABILIFY2MGTABLET / ORALABRLD2002-11-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021436-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021436-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N021436-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021436-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N021436-005AB1a50c72e98297…
2026-08-01 22:54:322026-06N021436-006AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N021436-00191259392026-07-28U-17492015-10-07a50c72e98297…
2026-08-01 22:54:322026-06N021436-00187593502027-03-02U-15292014-07-22a50c72e98297…
2026-08-01 22:54:322026-06N021436-00291259392026-07-28U-17492015-10-07a50c72e98297…
2026-08-01 22:54:322026-06N021436-00287593502027-03-02U-15292014-07-22a50c72e98297…
2026-08-01 22:54:322026-06N021436-00391259392026-07-28U-17492015-10-07a50c72e98297…
2026-08-01 22:54:322026-06N021436-00387593502027-03-02U-15292014-07-22a50c72e98297…
2026-08-01 22:54:322026-06N021436-00491259392026-07-28U-17492015-10-07a50c72e98297…
2026-08-01 22:54:322026-06N021436-00487593502027-03-02U-15292014-07-22a50c72e98297…
2026-08-01 22:54:322026-06N021436-00591259392026-07-28U-17492015-10-07a50c72e98297…
2026-08-01 22:54:322026-06N021436-00587593502027-03-02U-15292014-07-22a50c72e98297…
2026-08-01 22:54:322026-06N021436-00691259392026-07-28U-17492015-10-07a50c72e98297…
2026-08-01 22:54:322026-06N021436-00687593502027-03-02U-15292014-07-22a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABILIFYARIPIPRAZOLEOtsuka America Pharmaceutical, Inc.c040bd1d-45b7-49f2-93ea-aed7220b30ac2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021436
application number: NDA021436

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
52959-604-302019-11-13C16284748780-197449f38-c983-f6ea-e053-dbdaa90aa703These 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
52959-604-30ABILIFY30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-604-30EA - Each52959-604f796cef8-5711-4ad9-b76f-e1bcbc90537e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-604ABILIFY (ARIPIPRAZOLE) TABLET [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 1 package rows20120118_d8275c2d-f42d-4f32-aa9f-03a202c8e99f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404602ABILIFY 5 MG Oral TabletPSNd8275c2d-f42d-4f32-aa9f-03a202c8e99f3
402131ARIPiprazole 5 MG Oral TabletPSNd8275c2d-f42d-4f32-aa9f-03a202c8e99f3
404602aripiprazole 5 MG Oral Tablet [Abilify]SBDd8275c2d-f42d-4f32-aa9f-03a202c8e99f3
402131aripiprazole 5 MG Oral TabletSCDd8275c2d-f42d-4f32-aa9f-03a202c8e99f3
404602Abilify 5 MG Oral TabletSYd8275c2d-f42d-4f32-aa9f-03a202c8e99f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-604-305295906043030 in 1 BOTTLEHistorical