Aripiprazole

Product NDC
0093-7583
11-digit product format
000937583
Labeler code
0093
Product ID
0093-7583_858b23a3-f76c-4ce9-b531-51d97c18c245
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA078708
Marketing category
ANDA
Marketing start
2015-04-28
Marketing end
2019-07-31
Substance
ARIPIPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-7583DDiscontinued by firm2026-08-03
excluded packagepackage0093-75830093-7583-56DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0093-7583-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-7583-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-7583-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-7583-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-7583-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-7583-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-7583-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-7583-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-7583-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0093-7583-56ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0093-7583-56367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0093-7583-56557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078708-001ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORAL2015-04-28
A078708-002ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORAL2015-04-28
A078708-003ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORAL2015-04-28

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078708-002ARIPIPRAZOLE20MGTABLET / ORAL2015-04-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078708-003ARIPIPRAZOLE30MGTABLET / ORAL2015-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078708-001ARIPIPRAZOLE15MGTABLET / ORAL2015-04-288072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7583-56EA - Each0093-75830578a00e-dc0a-4fe0-9496-5e2baf5bf9da12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARIPIPRAZOLE TABLET [TEVA PHARMACEUTICALS USA INC]3