aripiprazole

Product NDC
68788-7006
Requested package NDC
68788-7006-2
11-digit product format
687887006
Labeler code
68788
Product ID
68788-7006_bd2ef8df-4b43-4151-9f23-c82a0a829daf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201519
Marketing category
ANDA
Marketing start
2017-08-16
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage68788-700668788-7006-2DDiscontinued 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 · 10 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…

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
A201519-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28
A201519-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28
A201519-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28
A201519-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28
A201519-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28
A201519-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201519-001AB
A201519-002AB
A201519-003AB
A201519-004AB
A201519-005AB
A201519-006AB

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 UTC2026-02A201519-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201519-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201519-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201519-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201519-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201519-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-282680178bc6a6…

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 UTC2026-02A201519-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201519-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201519-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201519-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201519-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201519-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201519-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201519-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201519-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201519-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201519-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201519-004AB12680178bc6a6…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aripiprazoleARIPIPRAZOLEREMEDYREPACK INC.1ad7d167-1235-4c5c-8159-da8972240ede2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEREMEDYREPACK INC.9b695d4b-3794-4b89-8575-6feb83697ccc2026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEMajor Pharmaceuticals969c17aa-6abc-413c-8561-f1ad8fdde3e52026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEProficient Rx LP2c2b0172-b186-4be4-a002-4a26adf120c62025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEProficient Rx LPa3c0be94-c6c0-47e2-892f-c51f100fb3a32025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEST. MARY'S MEDICAL PARK PHARMACY35a86989-862e-b0bb-e063-6394a90a7ec12025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLETorrent Pharmaceuticals Limited3988e66f-339c-451e-9f8a-9d0c0a2a381b2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
AripiprazoleARIPIPRAZOLEDirect_Rxf81d9b82-5879-3c0a-e053-6294a90ac23e2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.faa3032b-d9a1-45dd-88be-abb432223f132025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEBryant Ranch Prepacke7b6a156-8001-441c-bfd3-bf8987a339e82024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEBryant Ranch Prepackb62837db-1949-4dba-9e2f-714a9f136f5a2024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEBryant Ranch Prepackd130836c-5f1c-4779-ac6c-6350752dc0152024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519
aripiprazoleARIPIPRAZOLEA-S Medication Solutionsab3973f3-3db8-4db2-8258-1b21af7b63802024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201519
application number: ANDA201519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7006-26878870060220 TABLET in 1 BOTTLE (68788-7006-2) 20 tablet2017-08-160000-00-00NoNoCurrent