Aripiprazole

Product NDC
50090-4817
Requested package NDC
50090-4817-0
11-digit product format
500904817
Labeler code
50090
Product ID
50090-4817_14c1a2c5-8079-4224-b4ad-5947aff97062
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204111
Marketing category
ANDA
Marketing start
2018-03-07
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-481750090-4817-0IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A204111-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2016-10-07
A204111-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2016-10-07
A204111-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2016-10-07
A204111-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2016-10-07
A204111-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2016-10-07
A204111-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2016-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204111-001AB
A204111-002AB
A204111-003AB
A204111-004AB
A204111-005AB
A204111-006AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-072680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204111-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204111-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-004AB12680178bc6a6…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4817-0Aripiprazole30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4817ARIPIPRAZOLE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210416_8690e8a5-0bec-4aa2-8d70-62b54d8ea8c2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEMacleods Pharmaceuticals Limitedab4245a1-71f7-45be-a2ef-b0636ed3cc202025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204111
application number: ANDA204111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349490ARIPiprazole 15 MG Oral TabletPSN8690e8a5-0bec-4aa2-8d70-62b54d8ea8c23
349490aripiprazole 15 MG Oral TabletSCD8690e8a5-0bec-4aa2-8d70-62b54d8ea8c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4817-05009048170030 TABLET in 1 BOTTLE (50090-4817-0) 30 tablet2019-12-310000-00-00NoNoCurrent