Risperidone

Product NDC
43353-766
11-digit product format
433530766
Labeler code
43353
Product ID
43353-766_9139290e-82d1-40ea-afbe-4fd7be934799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076288
Marketing category
ANDA
Marketing start
2008-09-17
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-766IInactivated by FDA2026-08-03
excluded packagepackage43353-76643353-766-30IInactivated by FDA2026-08-03

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 · 42 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 packagepackage43353-766-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-766-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-766-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-766-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-766-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-766-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-766-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-766-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-766-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-766-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-766-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-766-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43353-766-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43353-766-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43353-766-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43353-766-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43353-766-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43353-766-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43353-766-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43353-766-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43353-766-309bebd1f3094a…5416666fcb17…

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
A076288-001RISPERIDONERISPERIDONE0.25MGTABLET / ORAL2008-09-15
A076288-002RISPERIDONERISPERIDONE0.5MGTABLET / ORAL2008-09-15
A076288-003RISPERIDONERISPERIDONE1MGTABLET / ORAL2008-09-15
A076288-004RISPERIDONERISPERIDONE2MGTABLET / ORAL2008-09-15
A076288-005RISPERIDONERISPERIDONE3MGTABLET / ORAL2008-09-15
A076288-006RISPERIDONERISPERIDONE4MGTABLET / ORAL2008-09-15

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 UTC2026-02A076288-001RISPERIDONE0.25MGTABLET / ORAL2008-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076288-002RISPERIDONE0.5MGTABLET / ORAL2008-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076288-003RISPERIDONE1MGTABLET / ORAL2008-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076288-004RISPERIDONE2MGTABLET / ORAL2008-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076288-005RISPERIDONE3MGTABLET / ORAL2008-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076288-006RISPERIDONE4MGTABLET / ORAL2008-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076288-001RISPERIDONE0.25MGTABLET / ORAL2008-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076288-002RISPERIDONE0.5MGTABLET / ORAL2008-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076288-003RISPERIDONE1MGTABLET / ORAL2008-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076288-004RISPERIDONE2MGTABLET / ORAL2008-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076288-005RISPERIDONE3MGTABLET / ORAL2008-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076288-006RISPERIDONE4MGTABLET / ORAL2008-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076288-001RISPERIDONE0.25MGTABLET / ORAL2008-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076288-002RISPERIDONE0.5MGTABLET / ORAL2008-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076288-003RISPERIDONE1MGTABLET / ORAL2008-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076288-004RISPERIDONE2MGTABLET / ORAL2008-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076288-005RISPERIDONE3MGTABLET / ORAL2008-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076288-006RISPERIDONE4MGTABLET / ORAL2008-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076288-001RISPERIDONE0.25MGTABLET / ORAL2008-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076288-002RISPERIDONE0.5MGTABLET / ORAL2008-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076288-003RISPERIDONE1MGTABLET / ORAL2008-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076288-004RISPERIDONE2MGTABLET / ORAL2008-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076288-005RISPERIDONE3MGTABLET / ORAL2008-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076288-006RISPERIDONE4MGTABLET / ORAL2008-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076288-001RISPERIDONE0.25MGTABLET / ORAL2008-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076288-002RISPERIDONE0.5MGTABLET / ORAL2008-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076288-003RISPERIDONE1MGTABLET / ORAL2008-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076288-004RISPERIDONE2MGTABLET / ORAL2008-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076288-005RISPERIDONE3MGTABLET / ORAL2008-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076288-006RISPERIDONE4MGTABLET / ORAL2008-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076288-001RISPERIDONE0.25MGTABLET / ORAL2008-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076288-002RISPERIDONE0.5MGTABLET / ORAL2008-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076288-003RISPERIDONE1MGTABLET / ORAL2008-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076288-004RISPERIDONE2MGTABLET / ORAL2008-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076288-005RISPERIDONE3MGTABLET / ORAL2008-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076288-006RISPERIDONE4MGTABLET / ORAL2008-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076288-001RISPERIDONE0.25MGTABLET / ORAL2008-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076288-002RISPERIDONE0.5MGTABLET / ORAL2008-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076288-003RISPERIDONE1MGTABLET / ORAL2008-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076288-004RISPERIDONE2MGTABLET / ORAL2008-09-152680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076288-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076288-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076288-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076288-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076288-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076288-006AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A076288-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076288-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076288-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076288-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076288-005AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076288-006AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076288-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076288-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076288-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076288-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076288-005AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076288-006AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076288-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076288-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076288-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076288-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076288-005AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076288-006AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6Product name520250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09eProduct name120250128
e457a910-2c3a-4bfd-90b9-0310982c50ddProduct name120241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-766-30Risperidone30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-766-30EA - Each43353-766d04ce210-ac2a-4710-807b-76a7d7e4b54a12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-766RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 1 package rows20140509_50aec836-fbfd-49af-9448-912b8279a7f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312830risperiDONE 1 MG Oral TabletPSN50aec836-fbfd-49af-9448-912b8279a7f93
312831risperiDONE 2 MG Oral TabletPSN50aec836-fbfd-49af-9448-912b8279a7f93
312832risperiDONE 3 MG Oral TabletPSN50aec836-fbfd-49af-9448-912b8279a7f93
314211risperiDONE 4 MG Oral TabletPSN50aec836-fbfd-49af-9448-912b8279a7f93
312830risperidone 1 MG Oral TabletSCD50aec836-fbfd-49af-9448-912b8279a7f93
312831risperidone 2 MG Oral TabletSCD50aec836-fbfd-49af-9448-912b8279a7f93
312832risperidone 3 MG Oral TabletSCD50aec836-fbfd-49af-9448-912b8279a7f93
314211risperidone 4 MG Oral TabletSCD50aec836-fbfd-49af-9448-912b8279a7f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-766-304335307663030 in 1 BOTTLE, PLASTICHistorical