FDA.reportPublic FDA data

Aripiprazole

Product NDC
72578-106
11-digit product format
725780106
Labeler code
72578
Product ID
72578-106_62486381-abea-40d9-aa88-bf3f3665a65f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Viona Pharmaceuticals Inc.
Application
ANDA090165
Marketing category
ANDA
Marketing start
2022-07-20
Substance
ARIPIPRAZOLE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090165-001ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28
A090165-002ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28
A090165-003ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28
A090165-004ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090165-001AB
A090165-002AB

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090165-001ARIPIPRAZOLE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090165-002ARIPIPRAZOLE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2018-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090165-003ARIPIPRAZOLE20MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090165-004ARIPIPRAZOLE30MGTABLET, ORALLY DISINTEGRATING / ORAL2018-08-28d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090165-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090165-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090165-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090165-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090165-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090165-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090165-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090165-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090165-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090165-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090165-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090165-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090165-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090165-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090165-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090165-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090165-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090165-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090165-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090165-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090165-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090165-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090165-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090165-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090165-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090165-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090165-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090165-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090165-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090165-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090165-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090165-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090165-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090165-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090165-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090165-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090165-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090165-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090165-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090165-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2026-12-31

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
73c5e380-b7b1-4362-a827-71881574ff48Available 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
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-106-06Aripiprazole30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3011
72578-106-30Aripiprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1011
72578-106-78Aripiprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-106-06EA - Each72578-1065ef88e41-9de0-41da-93c0-0128ede358ef12022-09-12
72578-106-30EA - Each72578-1061f86a21c-41c3-49dc-b9a4-02b7c2e9bbb612025-06-13
72578-106-78EA - Each72578-106612c2bf6-9ebf-460f-874a-f656876841f712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-106ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING [VIONA PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 3 package rows20250205_73c5e380-b7b1-4362-a827-71881574ff48.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEViona Pharmaceuticals Inc.73c5e380-b7b1-4362-a827-71881574ff482025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090165
application number: ANDA090165
ndc (product): 72578-106
AripiprazoleARIPIPRAZOLESQUARE PHARMACEUTICALS LIMITED0f9b1fd8-a648-45c9-8655-14de07439f342023-07-02Exact identifier
application applno (ANDA): 090165
application number: ANDA090165

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
643019ARIPiprazole 10 MG Disintegrating Oral TabletPSN73c5e380-b7b1-4362-a827-71881574ff4811
643022ARIPiprazole 15 MG Disintegrating Oral TabletPSN73c5e380-b7b1-4362-a827-71881574ff4811
643019aripiprazole 10 MG Disintegrating Oral TabletSCD73c5e380-b7b1-4362-a827-71881574ff4811
643022aripiprazole 15 MG Disintegrating Oral TabletSCD73c5e380-b7b1-4362-a827-71881574ff4811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-106-067257801060630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72578-106-06) 2022-07-200000-00-00NoNoCurrent
72578-106-307257801063010 in 1 BLISTER PACKHistorical
72578-106-78725780106783 BLISTER PACK in 1 CARTON (72578-106-78) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-106-30) 3 blister pack2023-02-22NoNoCurrent