Aripiprazole

Product NDC
72189-466
11-digit product format
721890466
Labeler code
72189
Product ID
72189-466_2c4def88-252d-7c8b-e063-6294a90aeb94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207105
Marketing category
ANDA
Marketing start
2023-05-03
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

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-466-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-466-300efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207105-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21
A207105-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21
A207105-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21
A207105-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21
A207105-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2019-02-21
A207105-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2019-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207105-001AB
A207105-002AB
A207105-003AB
A207105-004AB
A207105-005AB
A207105-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-08-18 06:07:402026-07A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207105-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A207105-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207105-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207105-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-004AB1b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
facdb9a9-612f-e59a-e053-6394a90a1fa7Available 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
72189-466-30Aripiprazole30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-466-30EA - Each72189-4664fb1f3ec-52fa-486d-ba27-a83e339f051712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-466ARIPIPRAZOLE TABLET [DIRECT_RX]2Current NDC, 1 package rows20250123_facdb9a9-612f-e59a-e053-6394a90a1fa7.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.1d593ada-256d-4dec-9a26-2a6a67d972052026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.bc3fde41-2f24-44e2-815d-15fe55bd68b32026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.506fa28f-6f98-4632-bce8-72a9cb507c902026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.f713c38e-cc49-4243-96b9-32d5dbbcf9cb2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLECoupler LLC55f3a705-9412-0f88-e063-6294a90a2b532026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLECoupler LLC55f446b0-caa2-aca8-e063-6294a90af4412026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLECoupler LLC52bbfc8f-fa17-839e-e063-6394a90a63162026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLECoupler LLC50214c47-2ea3-b373-e063-6394a90aad232026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.6f580e75-61ab-4c7b-bb3f-f027a9603f842026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.433cdc7d-465a-4ad4-bd84-cabd37e15f512026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackff8dc838-ca1a-49d3-8938-5ae645574a752026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1e8d889e-126b-4627-a2cc-34f2d35a5d672026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack1ef9e44f-5672-47c2-97e9-286e1b84417d2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack4bda6f17-d87c-4009-b329-99275c56106f2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackfb40b669-4e37-4087-8fb1-3ac1405436022026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEA-S Medication Solutions554db933-aa80-4685-bcd5-58c84571c19c2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEAscend Laboratories, LLCc7040fef-96a7-4429-9a8e-ec3ab17a80192025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEDirect_Rxfacdb9a9-612f-e59a-e053-6394a90a1fa72025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
ndc (product): 72189-466
AripiprazoleARIPIPRAZOLEDirect_Rxfcea91c3-e428-8991-e053-6394a90a099d2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.34127431-6ad7-402f-bc22-1429c55d921c2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602964ARIPiprazole 2 MG Oral TabletPSNfacdb9a9-612f-e59a-e053-6394a90a1fa72
602964aripiprazole 2 MG Oral TabletSCDfacdb9a9-612f-e59a-e053-6394a90a1fa72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-466-307218904663030 TABLET in 1 BOTTLE (72189-466-30) 30 tablet2023-05-03NoNoCurrent