FDA.reportPublic FDA data

Aripiprazole

Product NDC
59651-514
11-digit product format
596510514
Labeler code
59651
Product ID
59651-514_da73c5ab-4841-4081-8fdf-adc2ea343dcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216208
Marketing category
ANDA
Marketing start
2026-02-18
Substance
ARIPIPRAZOLE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216208-001ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORAL2026-02-18
A216208-002ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORAL2026-02-18

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
2026-09-14 22:38:342026-08A216208-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORAL2026-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A216208-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORAL2026-02-1884e616aacf4f…
2026-08-18 06:07:402026-07A216208-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A216208-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-02-18caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216208-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-02-18a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216208-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-02-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A216208-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A216208-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216208-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216208-002AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82VFR53I78Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
643019Internal RxNorm lookup
643022Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476b92f3-cf7b-4c09-ac67-6ed35e6811d5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-514-03Aripiprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101
59651-514-03Aripiprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING31
59651-514-30Aripiprazole30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING301

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEAurobindo Pharma Limited476b92f3-cf7b-4c09-ac67-6ed35e6811d52026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216208
application number: ANDA216208
ndc (product): 59651-514

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
643019ARIPiprazole 10 MG Disintegrating Oral TabletPSN476b92f3-cf7b-4c09-ac67-6ed35e6811d51
643022ARIPiprazole 15 MG Disintegrating Oral TabletPSN476b92f3-cf7b-4c09-ac67-6ed35e6811d51
643019aripiprazole 10 MG Disintegrating Oral TabletSCD476b92f3-cf7b-4c09-ac67-6ed35e6811d51
643022aripiprazole 15 MG Disintegrating Oral TabletSCD476b92f3-cf7b-4c09-ac67-6ed35e6811d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-514-03596510514033 BLISTER PACK in 1 CARTON (59651-514-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2026-02-18NoNoCurrent
59651-514-305965105143030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-514-30) 2026-02-18NoNoCurrent