Aripiprazole

Product NDC
70518-2281
11-digit product format
705182281
Labeler code
70518
Product ID
70518-2281_49f0c1be-04d3-7c85-e063-6394a90ab715
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202101
Marketing category
ANDA
Marketing start
2019-08-26
Substance
ARIPIPRAZOLE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage70518-228170518-2281-0DDiscontinued 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 · 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 packagepackage70518-2281-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2281-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2281-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2281-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2281-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2281-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2281-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2281-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2281-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2281-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2281-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2281-0557ba5c1ecfa…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
A202101-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28
A202101-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28
A202101-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28
A202101-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28
A202101-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28
A202101-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / 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
A202101-001AB
A202101-002AB
A202101-003AB
A202101-004AB
A202101-005AB
A202101-006AB

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 UTC2026-02A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-004ARIPIPRAZOLE15MGTABLET / 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 UTC2026-02A202101-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202101-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82VFR53I78Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349545Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
119e3387-39a2-4fe5-904b-c2d008425c0aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2281-0Aripiprazole100 in 1 BOXTABLET1005
70518-2281-1Aripiprazole1 in 1 POUCHTABLET15
70518-2281-2Aripiprazole30 in 1 BLISTER PACKTABLET305

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.119e3387-39a2-4fe5-904b-c2d008425c0a2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
ndc (product): 70518-2281
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.99747897-22fe-4bee-9942-6349c0c8f6b02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLECoupler LLC56439ef6-a07e-34c9-e063-6294a90a77c32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLECoupler LLC52cc86ba-2c4f-1aba-e063-6294a90a844e2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLECoupler LLC512874e6-6d00-2623-e063-6394a90aa4bc2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.02a4af27-c83c-4166-950c-7a1cb12d198d2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Inc.a10a5427-58b1-42dd-964c-3f8c787705342025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Limited793fc904-2f11-4f97-a0ac-4d6910cac0f92023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN119e3387-39a2-4fe5-904b-c2d008425c0a5
349545aripiprazole 10 MG Oral TabletSCD119e3387-39a2-4fe5-904b-c2d008425c0a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-2281-070518228100100 in 1 BOXHistorical
70518-2281-1705182281011 in 1 POUCHHistorical
70518-2281-27051822810230 TABLET in 1 BLISTER PACK (70518-2281-2) 30 tablet2025-07-08NoNoCurrent