Aripiprazole

Product NDC
27241-051
11-digit product format
272410051
Labeler code
27241
Product ID
27241-051_2a724a23-cf45-4d22-90f5-ebe68f9b7ab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA206174
Marketing category
ANDA
Marketing start
2017-05-30
Substance
ARIPIPRAZOLE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
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
2026-12-31

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 · 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
d0f910b5-adef-4a93-9369-70f1ed541503Available 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
27241-051-03Aripiprazole30 in 1 BOTTLETABLET3020
27241-051-08Aripiprazole500 in 1 BOTTLETABLET50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-051-03EA - Each27241-051fb4b95c9-ed0b-4e80-a293-37de99bb14e112016-11-08
27241-051-08EA - Each27241-051387fac71-ceb8-4fe2-b982-f608d637367212017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-051ARIPIPRAZOLE TABLET [AJANTA PHARMA USA INC.]18Current NDC, Legacy NDC, 2 package rows20231021_d0f910b5-adef-4a93-9369-70f1ed541503.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 · 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
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
ndc (product): 27241-051
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
349545ARIPiprazole 10 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
349490ARIPiprazole 15 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
602964ARIPiprazole 2 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
349553ARIPiprazole 20 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
349547ARIPiprazole 30 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
402131ARIPiprazole 5 MG Oral TabletPSNd0f910b5-adef-4a93-9369-70f1ed54150320
349545aripiprazole 10 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
349490aripiprazole 15 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
602964aripiprazole 2 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
349553aripiprazole 20 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
349547aripiprazole 30 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
402131aripiprazole 5 MG Oral TabletSCDd0f910b5-adef-4a93-9369-70f1ed54150320
602964ARIPiprazole 2 MG Oral TabletPSNc092a736-16e2-4dd0-8769-cb766a62f4d98
602964ARIPiprazole 2 MG Oral TabletPSN2bc00231-c2e7-4b9d-93a1-fb796fd8d5918
602964aripiprazole 2 MG Oral TabletSCDc092a736-16e2-4dd0-8769-cb766a62f4d98
602964aripiprazole 2 MG Oral TabletSCD2bc00231-c2e7-4b9d-93a1-fb796fd8d5918
602964ARIPiprazole 2 MG Oral TabletPSN47430dfa-9377-6c31-e063-6394a90a86a91
602964aripiprazole 2 MG Oral TabletSCD47430dfa-9377-6c31-e063-6394a90a86a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-051-032724100510330 TABLET in 1 BOTTLE (27241-051-03) 30 tablet2017-05-300000-00-00NoNoCurrent
27241-051-0827241005108500 TABLET in 1 BOTTLE (27241-051-08) 500 tablet2017-05-300000-00-00NoNoCurrent