FDA.reportPublic FDA data

Risperidone

Product NDC
59115-090
11-digit product format
591150090
Labeler code
59115
Product ID
59115-090_80d1c42b-ace1-4240-aca5-cbe5c2bd82e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceutical
Application
ANDA078740
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
A078740-001RISPERIDONERISPERIDONE0.25MGTABLET / ORAL2009-05-29
A078740-002RISPERIDONERISPERIDONE0.5MGTABLET / ORAL2009-05-29
A078740-003RISPERIDONERISPERIDONE1MGTABLET / ORAL2009-05-29
A078740-004RISPERIDONERISPERIDONE2MGTABLET / ORAL2009-05-29
A078740-005RISPERIDONERISPERIDONE3MGTABLET / ORAL2009-05-29
A078740-006RISPERIDONERISPERIDONE4MGTABLET / ORAL2009-05-29

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 22:38:342026-08A078740-001RISPERIDONE0.25MGTABLET / ORAL2009-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A078740-002RISPERIDONE0.5MGTABLET / ORAL2009-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A078740-003RISPERIDONE1MGTABLET / ORAL2009-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A078740-004RISPERIDONE2MGTABLET / ORAL2009-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A078740-005RISPERIDONE3MGTABLET / ORAL2009-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A078740-006RISPERIDONE4MGTABLET / ORAL2009-05-2984e616aacf4f…
2026-08-18 06:07:402026-07A078740-001RISPERIDONE0.25MGTABLET / ORAL2009-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078740-002RISPERIDONE0.5MGTABLET / ORAL2009-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078740-003RISPERIDONE1MGTABLET / ORAL2009-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078740-004RISPERIDONE2MGTABLET / ORAL2009-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078740-005RISPERIDONE3MGTABLET / ORAL2009-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078740-006RISPERIDONE4MGTABLET / ORAL2009-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078740-001RISPERIDONE0.25MGTABLET / ORAL2009-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078740-002RISPERIDONE0.5MGTABLET / ORAL2009-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078740-003RISPERIDONE1MGTABLET / ORAL2009-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078740-004RISPERIDONE2MGTABLET / ORAL2009-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078740-005RISPERIDONE3MGTABLET / ORAL2009-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078740-006RISPERIDONE4MGTABLET / ORAL2009-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078740-001RISPERIDONE0.25MGTABLET / ORAL2009-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078740-002RISPERIDONE0.5MGTABLET / ORAL2009-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078740-003RISPERIDONE1MGTABLET / ORAL2009-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078740-004RISPERIDONE2MGTABLET / ORAL2009-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078740-005RISPERIDONE3MGTABLET / ORAL2009-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078740-006RISPERIDONE4MGTABLET / ORAL2009-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078740-001RISPERIDONE0.25MGTABLET / ORAL2009-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078740-002RISPERIDONE0.5MGTABLET / ORAL2009-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078740-003RISPERIDONE1MGTABLET / ORAL2009-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078740-004RISPERIDONE2MGTABLET / ORAL2009-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078740-005RISPERIDONE3MGTABLET / ORAL2009-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078740-006RISPERIDONE4MGTABLET / ORAL2009-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078740-001RISPERIDONE0.25MGTABLET / ORAL2009-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078740-002RISPERIDONE0.5MGTABLET / ORAL2009-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078740-003RISPERIDONE1MGTABLET / ORAL2009-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078740-004RISPERIDONE2MGTABLET / ORAL2009-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078740-005RISPERIDONE3MGTABLET / ORAL2009-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078740-006RISPERIDONE4MGTABLET / ORAL2009-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078740-001RISPERIDONE0.25MGTABLET / ORAL2009-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078740-002RISPERIDONE0.5MGTABLET / ORAL2009-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078740-003RISPERIDONE1MGTABLET / ORAL2009-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078740-004RISPERIDONE2MGTABLET / ORAL2009-05-29b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IERISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ARISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6
TRIACETININACTIVE INGREDIENTXHX3C3X673RISPERIDONE TABLET [HIKMA PHARMACEUTICAL]6