Aripiprazole

Product NDC
43353-148
Requested package NDC
43353-148-45
11-digit product format
433530148
Labeler code
43353
Product ID
43353-148_d4065c9f-d681-4d49-af2b-a12985ca3e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078583
Marketing category
ANDA
Marketing start
2015-07-28
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage43353-14843353-148-45DDiscontinued by firm2026-08-03

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 · 12 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…

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
A078583-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORAL2015-07-24
A078583-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORAL2015-07-24
A078583-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORAL2015-07-24
A078583-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORAL2015-07-24
A078583-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORAL2015-07-24
A078583-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORAL2015-07-24

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 UTC2026-02A078583-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078583-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078583-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078583-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078583-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078583-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-07-242680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 240 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078583-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078583-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078583-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078583-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078583-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078583-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078583-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078583-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078583-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078583-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078583-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078583-004AB12680178bc6a6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-148-15EA - Each43353-14867b7908c-fca2-42fd-aa0f-006cf15d2fba12016-07-19
43353-148-45EA - Each43353-1489269afd0-60f5-434d-87e2-968ca7f71b8012016-07-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-148-454335301484545 TABLET in 1 BOTTLE (43353-148-45) 45 tablet2016-02-150000-00-00NoNoCurrent