Aripiprazole

Product NDC
46708-256
11-digit product format
467080256
Labeler code
46708
Product ID
46708-256_5108607e-5633-4b19-82f9-6c48720960c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA202101
Marketing category
ANDA
Marketing start
2015-04-28
Substance
ARIPIPRAZOLE
Active strength
10 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
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
2026-12-31

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
793fc904-2f11-4f97-a0ac-4d6910cac0f9Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
46708-256-102023-02-01These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-302023-02-01These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-312023-02-01These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-712023-02-01These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-912023-02-01These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-102023-01-30These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-302023-01-30These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-312023-01-30These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-712023-01-30These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-256-912023-01-30These highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-256-10Aripiprazole100 in 1 CARTONTABLET1003
46708-256-30Aripiprazole30 in 1 BOTTLETABLET303
46708-256-31Aripiprazole100 in 1 BOTTLETABLET1003
46708-256-71Aripiprazole500 in 1 BOTTLETABLET5003
46708-256-91Aripiprazole1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-256ARIPIPRAZOLE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 5 package rows20230202_793fc904-2f11-4f97-a0ac-4d6910cac0f9.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 · 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
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
ndc (product): 46708-256

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
349490ARIPiprazole 15 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
602964ARIPiprazole 2 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
349553ARIPiprazole 20 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
349547ARIPiprazole 30 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
402131ARIPiprazole 5 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
349545aripiprazole 10 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
349490aripiprazole 15 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
602964aripiprazole 2 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
349553aripiprazole 20 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
349547aripiprazole 30 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
402131aripiprazole 5 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-256-1046708025610100 TABLET in 1 CARTON (46708-256-10) 100 tablet2015-04-280000-00-00NoNoCurrent
46708-256-304670802563030 TABLET in 1 BOTTLE (46708-256-30) 30 tablet2015-04-280000-00-00NoNoCurrent
46708-256-3146708025631100 TABLET in 1 BOTTLE (46708-256-31) 100 tablet2015-04-280000-00-00NoNoCurrent
46708-256-7146708025671500 TABLET in 1 BOTTLE (46708-256-71) 500 tablet2015-04-280000-00-00NoNoCurrent
46708-256-91467080256911000 TABLET in 1 BOTTLE (46708-256-91) 1000 tablet2015-04-280000-00-00NoNoCurrent