ARIPIPRAZOLE

Product NDC
70518-2669
Requested package NDC
70518-2669-0
11-digit product format
705182669
Labeler code
70518
Product ID
70518-2669_cc734b6d-ff94-3d12-e053-2995a90ac74e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205363
Marketing category
ANDA
Marketing start
2020-04-03
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
10 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 packagepackage70518-266970518-2669-0DDiscontinued 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
A205363-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2017-12-04
A205363-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2017-12-04
A205363-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2017-12-04
A205363-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2017-12-04
A205363-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2017-12-04
A205363-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2017-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205363-001AB
A205363-002AB
A205363-003AB
A205363-004AB
A205363-005AB
A205363-006AB

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 UTC2026-02A205363-001ARIPIPRAZOLE2MGTABLET / ORALAB2017-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-002ARIPIPRAZOLE5MGTABLET / ORALAB2017-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-003ARIPIPRAZOLE10MGTABLET / ORALAB2017-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-004ARIPIPRAZOLE15MGTABLET / ORALAB2017-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-005ARIPIPRAZOLE20MGTABLET / ORALAB2017-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-006ARIPIPRAZOLE30MGTABLET / ORALAB2017-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-001ARIPIPRAZOLE2MGTABLET / ORALAB2017-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-002ARIPIPRAZOLE5MGTABLET / ORALAB2017-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-003ARIPIPRAZOLE10MGTABLET / ORALAB2017-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-004ARIPIPRAZOLE15MGTABLET / ORALAB2017-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-005ARIPIPRAZOLE20MGTABLET / ORALAB2017-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-006ARIPIPRAZOLE30MGTABLET / ORALAB2017-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205363-001ARIPIPRAZOLE2MGTABLET / ORALAB2017-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-002ARIPIPRAZOLE5MGTABLET / ORALAB2017-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-003ARIPIPRAZOLE10MGTABLET / ORALAB2017-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-004ARIPIPRAZOLE15MGTABLET / ORALAB2017-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-005ARIPIPRAZOLE20MGTABLET / ORALAB2017-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-006ARIPIPRAZOLE30MGTABLET / ORALAB2017-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-001ARIPIPRAZOLE2MGTABLET / ORALAB2017-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-002ARIPIPRAZOLE5MGTABLET / ORALAB2017-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-003ARIPIPRAZOLE10MGTABLET / ORALAB2017-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-004ARIPIPRAZOLE15MGTABLET / ORALAB2017-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-005ARIPIPRAZOLE20MGTABLET / ORALAB2017-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-006ARIPIPRAZOLE30MGTABLET / ORALAB2017-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-001ARIPIPRAZOLE2MGTABLET / ORALAB2017-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-002ARIPIPRAZOLE5MGTABLET / ORALAB2017-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-003ARIPIPRAZOLE10MGTABLET / ORALAB2017-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-004ARIPIPRAZOLE15MGTABLET / ORALAB2017-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-005ARIPIPRAZOLE20MGTABLET / ORALAB2017-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-006ARIPIPRAZOLE30MGTABLET / ORALAB2017-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-001ARIPIPRAZOLE2MGTABLET / ORALAB2017-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-002ARIPIPRAZOLE5MGTABLET / ORALAB2017-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-003ARIPIPRAZOLE10MGTABLET / ORALAB2017-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-004ARIPIPRAZOLE15MGTABLET / ORALAB2017-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-005ARIPIPRAZOLE20MGTABLET / ORALAB2017-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-006ARIPIPRAZOLE30MGTABLET / ORALAB2017-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205363-001ARIPIPRAZOLE2MGTABLET / ORALAB2017-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205363-002ARIPIPRAZOLE5MGTABLET / ORALAB2017-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205363-003ARIPIPRAZOLE10MGTABLET / ORALAB2017-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205363-004ARIPIPRAZOLE15MGTABLET / ORALAB2017-12-042680178bc6a6…

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 UTC2026-02A205363-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205363-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205363-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205363-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205363-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205363-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205363-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205363-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205363-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205363-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205363-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205363-004AB12680178bc6a6…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARIPIPRAZOLEARIPIPRAZOLESolco Healthcare U.S., LLCabb8ad7e-7998-4485-a09f-a2892190f4ad2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205363
application number: ANDA205363
ARIPIPRAZOLEARIPIPRAZOLEA-S Medication Solutionsdb6fc74e-4989-464d-9c19-a5b7a541fd462024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205363
application number: ANDA205363
ARIPIPRAZOLEARIPIPRAZOLESolco Healthcare U.S., LLC686d0088-ac61-41df-8909-ae12f79576442023-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205363
application number: ANDA205363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2669-07051826690028 TABLET in 1 BLISTER PACK (70518-2669-0) 28 tablet2020-04-030000-00-00NoNoCurrent