Aripiprazole

Product NDC
70518-2736
11-digit product format
705182736
Labeler code
70518
Product ID
70518-2736_4a8cee22-16db-98ca-e063-6294a90aa648
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206174
Marketing category
ANDA
Marketing start
2020-05-12
Substance
ARIPIPRAZOLE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2736-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2736-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2736-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2736-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2736-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2736-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2736-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2736-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2736-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2736-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2736-0557ba5c1ecfa…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
A206174-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2016-09-12
A206174-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2016-09-12
A206174-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2016-09-12
A206174-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2016-09-12
A206174-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2016-09-12
A206174-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2016-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206174-001AB
A206174-002AB
A206174-003AB
A206174-004AB
A206174-005AB
A206174-006AB

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 UTC2026-02A206174-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A206174-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206174-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206174-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206174-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206174-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-122680178bc6a6…

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 UTC2026-02A206174-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206174-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206174-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206174-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206174-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206174-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206174-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206174-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206174-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206174-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206174-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206174-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE2 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
602964Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2bc00231-c2e7-4b9d-93a1-fb796fd8d591Available 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
70518-2736-0Aripiprazole30 in 1 BLISTER PACKTABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2736-0EA - Each70518-273627fe56c2-bfd6-48a1-8c6c-2820906045c212023-01-09

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack69af5199-f872-4298-8d09-035e2127d3d42026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
AripiprazoleARIPIPRAZOLEUnit Dose Solutions, Inc.535f4fbd-b6a7-7611-e063-6294a90a5c432026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackc092a736-16e2-4dd0-8769-cb766a62f4d92026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals, Inc.36fb0c13-dfae-46ac-bb71-0b53fe5649f42026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.2bc00231-c2e7-4b9d-93a1-fb796fd8d5912026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
ndc (product): 70518-2736
AripiprazoleARIPIPRAZOLECoupler LLC47430dfa-9377-6c31-e063-6394a90a86a92025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
AripiprazoleARIPIPRAZOLEQuallent Pharmaceuticals Health LLC0e0d42ad-f4c6-4e30-adc2-ab1d122428ec2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
AripiprazoleARIPIPRAZOLEAjanta Pharma USA Inc.d0f910b5-adef-4a93-9369-70f1ed5415032025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
AripiprazoleARIPIPRAZOLEA-S Medication Solutions13339e7f-a8b4-430d-b623-47372de983482024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackfd2fa4da-2ee9-4965-b1f8-ce1c8b73ba932023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206174
application number: ANDA206174

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602964ARIPiprazole 2 MG Oral TabletPSN2bc00231-c2e7-4b9d-93a1-fb796fd8d5918
602964aripiprazole 2 MG Oral TabletSCD2bc00231-c2e7-4b9d-93a1-fb796fd8d5918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2736-07051827360030 TABLET in 1 BLISTER PACK (70518-2736-0) 30 tablet2020-05-120000-00-00NoNoCurrent