Aripiprazole

Product NDC
50090-4936
11-digit product format
500904936
Labeler code
50090
Product ID
50090-4936_4e29d321-b967-427a-ba5b-a7959fcb08e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207105
Marketing category
ANDA
Marketing start
2019-02-27
Substance
ARIPIPRAZOLE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4936-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4936-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4936-08af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4936-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4936-0834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4936-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4936-01332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4936-11332a3947898…d4bfe170f9cd…

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
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349545Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
554db933-aa80-4685-bcd5-58c84571c19cAvailable 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4936-0Aripiprazole90 in 1 BOTTLETABLET907
50090-4936-1Aripiprazole30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4936-1EA - Each50090-493681949ede-6afa-477e-a865-8c6bd05af77212024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4936ARIPIPRAZOLE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20240808_554db933-aa80-4685-bcd5-58c84571c19c.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
ndc (product): 50090-4936
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
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
349545ARIPiprazole 10 MG Oral TabletPSN554db933-aa80-4685-bcd5-58c84571c19c7
349545aripiprazole 10 MG Oral TabletSCD554db933-aa80-4685-bcd5-58c84571c19c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4936-05009049360090 TABLET in 1 BOTTLE (50090-4936-0) 90 tablet2020-02-270000-00-00NoNoCurrent
50090-4936-15009049360130 TABLET in 1 BOTTLE (50090-4936-1) 30 tablet2020-02-270000-00-00NoNoCurrent