Aripiprazole

Product NDC
48433-116
11-digit product format
484330116
Labeler code
48433
Product ID
48433-116_3faad38f-c24b-4bcc-a602-a6d1dc99bfbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA078583
Marketing category
ANDA
Marketing start
2015-12-01
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct48433-116DDiscontinued by firm2026-10-15
excluded packagepackage48433-11648433-116-10DDiscontinued by firm2026-10-15

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 · 22 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 packagepackage48433-116-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage48433-116-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage48433-116-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage48433-116-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage48433-116-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage48433-116-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage48433-116-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage48433-116-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage48433-116-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage48433-116-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage48433-116-10367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078583-001ARIPIPRAZOLE2MGTABLET / ORAL2015-07-24c2088c7a36db…
2026-10-15 13:18:302026-09A078583-002ARIPIPRAZOLE5MGTABLET / ORAL2015-07-24c2088c7a36db…
2026-10-15 13:18:302026-09A078583-003ARIPIPRAZOLE10MGTABLET / ORAL2015-07-24c2088c7a36db…
2026-10-15 13:18:302026-09A078583-004ARIPIPRAZOLE15MGTABLET / ORAL2015-07-24c2088c7a36db…
2026-10-15 13:18:302026-09A078583-005ARIPIPRAZOLE20MGTABLET / ORAL2015-07-24c2088c7a36db…
2026-10-15 13:18:302026-09A078583-006ARIPIPRAZOLE30MGTABLET / ORAL2015-07-24c2088c7a36db…
2026-09-14 22:38:342026-08A078583-001ARIPIPRAZOLE2MGTABLET / ORAL2015-07-2484e616aacf4f…
2026-09-14 22:38:342026-08A078583-002ARIPIPRAZOLE5MGTABLET / ORAL2015-07-2484e616aacf4f…
2026-09-14 22:38:342026-08A078583-003ARIPIPRAZOLE10MGTABLET / ORAL2015-07-2484e616aacf4f…
2026-09-14 22:38:342026-08A078583-004ARIPIPRAZOLE15MGTABLET / ORAL2015-07-2484e616aacf4f…
2026-09-14 22:38:342026-08A078583-005ARIPIPRAZOLE20MGTABLET / ORAL2015-07-2484e616aacf4f…
2026-09-14 22:38:342026-08A078583-006ARIPIPRAZOLE30MGTABLET / ORAL2015-07-2484e616aacf4f…
2026-08-18 06:07:402026-07A078583-001ARIPIPRAZOLE2MGTABLET / ORAL2015-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078583-002ARIPIPRAZOLE5MGTABLET / ORAL2015-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078583-003ARIPIPRAZOLE10MGTABLET / ORAL2015-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078583-004ARIPIPRAZOLE15MGTABLET / ORAL2015-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078583-005ARIPIPRAZOLE20MGTABLET / ORAL2015-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078583-006ARIPIPRAZOLE30MGTABLET / ORAL2015-07-24caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 6 · 240 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078583-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078583-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078583-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078583-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078583-005AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078583-006AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078583-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078583-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078583-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078583-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078583-005AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078583-006AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078583-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078583-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078583-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078583-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078583-005AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078583-006AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078583-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078583-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078583-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078583-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078583-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078583-006AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078583-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078583-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078583-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078583-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078583-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078583-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078583-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078583-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078583-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078583-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078583-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078583-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078583-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078583-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078583-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078583-004AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-116-10EA - Each48433-116069b506f-2717-4668-a8f4-247802d9084e12016-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48433-116-104843301161010 BLISTER PACK in 1 BOX, UNIT-DOSE (48433-116-10) > 10 TABLET in 1 BLISTER PACK (48433-116-01) 10 blister pack2015-12-010000-00-00NoNoCurrent