Aripiprazole

Product NDC
67046-2046
11-digit product format
670462046
Labeler code
67046
Product ID
67046-2046_55f3b9a3-78a6-1b71-e063-6394a90a4d8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA207105
Marketing category
ANDA
Marketing start
2026-07-06
Substance
ARIPIPRAZOLE
Active strength
15 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 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE15 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
349490Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55f3a705-9412-0f88-e063-6294a90a2b53Available on FDA.report

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals, Inc.4894031e-639e-49d8-927a-76d684bf66552025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEPrefferred Pharmaceuticals Inc.fbb3ac69-8dba-42df-8d6d-ef3d79241edb2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.27874fe2-3fd6-002d-e063-6294a90a4cd72024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsbf3cf835-4c4e-47cb-be9c-bcb7c2e11cbe2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackee33be35-abc8-453f-98e9-7974026b7eb02024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEA-S Medication Solutions3ab6af7c-3169-46bf-bd3f-697c81bbcede2024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-2046-36704620460330 TABLET in 1 BLISTER PACK (67046-2046-3) 30 tablet2026-07-06NoNoCurrent