Risperidone

Product NDC
0615-7505
11-digit product format
006157505
Labeler code
0615
Product ID
0615-7505_cb1c057c-97ba-43a2-aceb-b2d096af0f6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA076288
Marketing category
ANDA
Marketing start
2008-09-17
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
0 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-7505DDiscontinued by firm2026-08-03
excluded packagepackage0615-75050615-7505-05DDiscontinued by firm2026-08-03
excluded packagepackage0615-75050615-7505-30DDiscontinued by firm2026-08-03
excluded packagepackage0615-75050615-7505-39DDiscontinued by firm2026-08-03

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 · 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 packagepackage0615-7505-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7505-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7505-39d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7505-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7505-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7505-39f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7505-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7505-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7505-392ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7505-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7505-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7505-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7505-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7505-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7505-39cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7505-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7505-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7505-39cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7505-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7505-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7505-39302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7505-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7505-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7505-39ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7505-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7505-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7505-390efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7505-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7505-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7505-39ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-7505-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-7505-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-7505-39367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-7505-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-7505-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-7505-39557ba5c1ecfa…9c80585c8c6e…

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34
TRIACETININACTIVE INGREDIENTXHX3C3X673RISPERIDONE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]34