Risperidone

Product NDC
57237-230
11-digit product format
572370230
Labeler code
57237
Product ID
57237-230_adb62990-1d1c-475e-aadc-3922d9aecac0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Citron Pharma LLC
Application
ANDA078269
Marketing category
ANDA
Marketing start
2008-10-08
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57237-230DDiscontinued by firm2026-10-05
excluded packagepackage57237-23057237-230-05DDiscontinued by firm2026-10-05
excluded packagepackage57237-23057237-230-10DDiscontinued by firm2026-10-05
excluded packagepackage57237-23057237-230-60DDiscontinued by firm2026-10-05

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57237-230-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57237-230-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57237-230-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57237-230-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57237-230-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57237-230-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57237-230-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57237-230-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57237-230-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57237-230-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57237-230-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57237-230-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57237-230-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57237-230-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57237-230-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57237-230-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57237-230-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57237-230-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57237-230-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57237-230-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57237-230-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57237-230-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57237-230-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57237-230-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57237-230-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57237-230-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57237-230-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57237-230-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57237-230-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57237-230-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57237-230-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57237-230-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57237-230-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57237-230-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57237-230-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57237-230-05557ba5c1ecfa…9c80585c8c6e…

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
A078269-001RISPERIDONERISPERIDONE0.25MGTABLET / ORALAB2008-10-08
A078269-002RISPERIDONERISPERIDONE0.5MGTABLET / ORALAB2008-10-08
A078269-003RISPERIDONERISPERIDONE1MGTABLET / ORALAB2008-10-08
A078269-004RISPERIDONERISPERIDONE2MGTABLET / ORALAB2008-10-08
A078269-005RISPERIDONERISPERIDONE3MGTABLET / ORALAB2008-10-08
A078269-006RISPERIDONERISPERIDONE4MGTABLET / ORALAB2008-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078269-001AB
A078269-002AB
A078269-003AB
A078269-004AB
A078269-005AB
A078269-006AB

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 22:38:342026-08A078269-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A078269-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A078269-003RISPERIDONE1MGTABLET / ORALAB2008-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A078269-004RISPERIDONE2MGTABLET / ORALAB2008-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A078269-005RISPERIDONE3MGTABLET / ORALAB2008-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A078269-006RISPERIDONE4MGTABLET / ORALAB2008-10-0884e616aacf4f…
2026-08-18 06:07:402026-07A078269-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-003RISPERIDONE1MGTABLET / ORALAB2008-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-004RISPERIDONE2MGTABLET / ORALAB2008-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-005RISPERIDONE3MGTABLET / ORALAB2008-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-006RISPERIDONE4MGTABLET / ORALAB2008-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078269-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-003RISPERIDONE1MGTABLET / ORALAB2008-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-004RISPERIDONE2MGTABLET / ORALAB2008-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-005RISPERIDONE3MGTABLET / ORALAB2008-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-006RISPERIDONE4MGTABLET / ORALAB2008-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-003RISPERIDONE1MGTABLET / ORALAB2008-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-004RISPERIDONE2MGTABLET / ORALAB2008-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-005RISPERIDONE3MGTABLET / ORALAB2008-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-006RISPERIDONE4MGTABLET / ORALAB2008-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078269-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-003RISPERIDONE1MGTABLET / ORALAB2008-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-004RISPERIDONE2MGTABLET / ORALAB2008-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-005RISPERIDONE3MGTABLET / ORALAB2008-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-006RISPERIDONE4MGTABLET / ORALAB2008-10-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-003RISPERIDONE1MGTABLET / ORALAB2008-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-004RISPERIDONE2MGTABLET / ORALAB2008-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-005RISPERIDONE3MGTABLET / ORALAB2008-10-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-006RISPERIDONE4MGTABLET / ORALAB2008-10-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078269-001RISPERIDONE0.25MGTABLET / ORALAB2008-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078269-002RISPERIDONE0.5MGTABLET / ORALAB2008-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078269-003RISPERIDONE1MGTABLET / ORALAB2008-10-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078269-004RISPERIDONE2MGTABLET / ORALAB2008-10-08b8a1b40f171c…

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 22:38:342026-08A078269-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078269-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078269-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078269-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078269-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A078269-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A078269-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078269-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078269-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078269-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078269-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078269-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078269-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078269-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078269-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078269-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078269-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078269-004AB1b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

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