Aripiprazole

Product NDC
50268-088
11-digit product format
502680088
Labeler code
50268
Product ID
50268-088_3d49db38-3629-6bb9-e063-6294a90a4b4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA205064
Marketing category
ANDA
Marketing start
2016-04-28
Substance
ARIPIPRAZOLE
Active strength
5 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
A205064-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28
A205064-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28
A205064-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28
A205064-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28
A205064-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28
A205064-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / 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
A205064-001AB
A205064-002AB
A205064-003AB
A205064-004AB
A205064-005AB
A205064-006AB

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 UTC2026-02A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-004ARIPIPRAZOLE15MGTABLET / 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 UTC2026-02A205064-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205064-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE5 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
7df4c83e-13d8-25b1-57eb-08d26ba03565Available 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
50268-088-11Aripiprazole1 in 1 BLISTER PACKTABLET16
50268-088-15Aripiprazole50 in 1 BOX, UNIT-DOSETABLET506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-088ARIPIPRAZOLE (ARIPIPRAZOLE) TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_7df4c83e-13d8-25b1-57eb-08d26ba03565.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.414b7fd2-6a63-af39-e063-6394a90a00b82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.0cf6655e-d59a-4ebd-9698-195cad2adbd52025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEAvPAK7df4c83e-13d8-25b1-57eb-08d26ba035652025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
ndc (product): 50268-088
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.3cf72cc6-ae43-bfd5-e063-6294a90a18b02025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEAmerican Health Packaging80e079f0-faf5-4c0c-b1a8-9bc3cc2cde002025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals,Inc.3726d102-dd9f-645e-e063-6294a90aeb9e2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEDirect_Rxf823bc23-27f3-2397-e053-6294a90a365a2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEA-S Medication Solutions89c2cddc-2ae3-4505-adf9-018542c713bf2024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack3c0109f6-0549-4f91-a259-d9d6d7329b912024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack6b0c3767-d397-4c7f-b229-083620d9ae6b2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLECamber Pharmaceuticals, Inc.2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa2024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLENorthStar RxLLCf87dbfe4-5417-47c9-a97f-d246cfc100232023-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.0a6fa113-6bb2-4f88-af07-ce0914c98ff22023-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.b284b294-40a0-4ccd-b7b7-b61267cd4e762023-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEExelan Pharmaceuticals, Inc.705190bf-9f9d-4183-a56b-4eeafeacde592018-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
ARIPIPRAZOLEARIPIPRAZOLECamber Pharmaceuticals, Inc.3718e585-06b9-40fd-a3eb-18b6497a42352017-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349490ARIPiprazole 15 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
602964ARIPiprazole 2 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349553ARIPiprazole 20 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349547ARIPiprazole 30 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
402131ARIPiprazole 5 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349545aripiprazole 10 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349490aripiprazole 15 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
602964aripiprazole 2 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349553aripiprazole 20 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349547aripiprazole 30 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
402131aripiprazole 5 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-088-11502680088111 in 1 BLISTER PACKHistorical
50268-088-155026800881550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-088-15) / 1 TABLET in 1 BLISTER PACK (50268-088-11) 50 blister pack2016-04-280000-00-00NoNoCurrent