Aripiprazole

Product NDC
65162-898
11-digit product format
651620898
Labeler code
65162
Product ID
65162-898_c125d854-8bb2-4467-83b4-c8a0e0f893c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204838
Marketing category
ANDA
Marketing start
2016-06-20
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

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
A204838-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17
A204838-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17
A204838-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17
A204838-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17
A204838-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2016-06-17
A204838-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2016-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204838-001AB
A204838-002AB
A204838-003AB
A204838-004AB
A204838-005AB
A204838-006AB

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 UTC2026-02A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-172680178bc6a6…

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 UTC2026-02A204838-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204838-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204838-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204838-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204838-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204838-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204838-004AB12680178bc6a6…

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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349490Internal RxNorm lookup
349545Internal RxNorm lookup
349547Internal RxNorm lookup
349553Internal RxNorm lookup
402131Internal RxNorm lookup
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
06dda03f-8481-46d6-af02-4f51e1a3a065Available 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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
65162-898-03Aripiprazole30 in 1 BOTTLETABLET3025
65162-898-09Aripiprazole90 in 1 BOTTLETABLET9025
65162-898-11Aripiprazole1000 in 1 BOTTLETABLET100025
65162-898-50Aripiprazole500 in 1 BOTTLETABLET50025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-898ARIPIPRAZOLE TABLET [AMNEAL PHARMACEUTICALS LLC]24Current NDC, Legacy NDC, 4 package rows20250416_06dda03f-8481-46d6-af02-4f51e1a3a065.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.a1191a90-eb83-4a59-948c-b9774d2c83a52026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838
AripiprazoleARIPIPRAZOLEMajor Pharmaceuticals573c6bb6-941f-4413-8c23-8260253858642026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838
AripiprazoleARIPIPRAZOLEAmneal Pharmaceuticals LLC06dda03f-8481-46d6-af02-4f51e1a3a0652025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838
ndc (product): 65162-898
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack96172aa4-9e13-4eca-83d5-85a88c1782d32024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838
AripiprazoleARIPIPRAZOLEProficient Rx LPdbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
349490ARIPiprazole 15 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
602964ARIPiprazole 2 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
349553ARIPiprazole 20 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
349547ARIPiprazole 30 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
402131ARIPiprazole 5 MG Oral TabletPSN06dda03f-8481-46d6-af02-4f51e1a3a06525
349545aripiprazole 10 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
349490aripiprazole 15 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
602964aripiprazole 2 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
349553aripiprazole 20 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
349547aripiprazole 30 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
402131aripiprazole 5 MG Oral TabletSCD06dda03f-8481-46d6-af02-4f51e1a3a06525
349545ARIPiprazole 10 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
349490ARIPiprazole 15 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
602964ARIPiprazole 2 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
349553ARIPiprazole 20 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
349547ARIPiprazole 30 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
402131ARIPiprazole 5 MG Oral TabletPSN573c6bb6-941f-4413-8c23-8260253858644
349545aripiprazole 10 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
349490aripiprazole 15 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
602964aripiprazole 2 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
349553aripiprazole 20 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
349547aripiprazole 30 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644
402131aripiprazole 5 MG Oral TabletSCD573c6bb6-941f-4413-8c23-8260253858644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-898-036516208980330 TABLET in 1 BOTTLE (65162-898-03) 30 tablet2016-06-200000-00-00NoNoCurrent
65162-898-096516208980990 TABLET in 1 BOTTLE (65162-898-09) 90 tablet2016-06-200000-00-00NoNoCurrent
65162-898-11651620898111000 TABLET in 1 BOTTLE (65162-898-11) 1000 tablet2016-06-200000-00-00NoNoCurrent
65162-898-5065162089850500 TABLET in 1 BOTTLE (65162-898-50) 500 tablet2016-06-200000-00-00NoNoCurrent