FDA.reportPublic FDA data

risperidone

Product NDC
68382-115
11-digit product format
683820115
Labeler code
68382
Product ID
68382-115_2af53e64-46a6-4b12-9ac8-8f8031a8bd97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078040
Marketing category
ANDA
Marketing start
2008-11-13
Substance
RISPERIDONE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
risperidone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312828, 312829, 312830, 312831, 312832, 314211

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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-115-01risperidone100 in 1 BOTTLETABLET, FILM COATED10025
68382-115-05risperidone500 in 1 BOTTLETABLET, FILM COATED50025
68382-115-06risperidone30 in 1 BOTTLETABLET, FILM COATED3025
68382-115-10risperidone1000 in 1 BOTTLETABLET, FILM COATED100025
68382-115-14risperidone60 in 1 BOTTLETABLET, FILM COATED6025
68382-115-16risperidone90 in 1 BOTTLETABLET, FILM COATED9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-115-05EA - Each68382-115fc78e5c3-5831-41e2-95cb-63cd0b29fd5012012-07-24
68382-115-14EA - Each68382-11578ce6953-73f5-45df-90f2-84ffe193e55012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]13
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ARISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-115RISPERIDONE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]24Current NDC, Legacy NDC, 6 package rows20250216_713b5ac7-53d6-4139-8599-3028f789de4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN713b5ac7-53d6-4139-8599-3028f789de4b25
312829risperiDONE 0.5 MG Oral TabletPSN713b5ac7-53d6-4139-8599-3028f789de4b25
312830risperiDONE 1 MG Oral TabletPSN713b5ac7-53d6-4139-8599-3028f789de4b25
312831risperiDONE 2 MG Oral TabletPSN713b5ac7-53d6-4139-8599-3028f789de4b25
312832risperiDONE 3 MG Oral TabletPSN713b5ac7-53d6-4139-8599-3028f789de4b25
314211risperiDONE 4 MG Oral TabletPSN713b5ac7-53d6-4139-8599-3028f789de4b25
312828risperidone 0.25 MG Oral TabletSCD713b5ac7-53d6-4139-8599-3028f789de4b25
312829risperidone 0.5 MG Oral TabletSCD713b5ac7-53d6-4139-8599-3028f789de4b25
312830risperidone 1 MG Oral TabletSCD713b5ac7-53d6-4139-8599-3028f789de4b25
312831risperidone 2 MG Oral TabletSCD713b5ac7-53d6-4139-8599-3028f789de4b25
312832risperidone 3 MG Oral TabletSCD713b5ac7-53d6-4139-8599-3028f789de4b25
314211risperidone 4 MG Oral TabletSCD713b5ac7-53d6-4139-8599-3028f789de4b25
312828risperiDONE 0.25 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312829risperiDONE 0.5 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312830risperiDONE 1 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312831risperiDONE 2 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312832risperiDONE 3 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
314211risperiDONE 4 MG Oral TabletPSNf11dae15-b057-4258-9229-3819d0c980fe16
312828risperidone 0.25 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312829risperidone 0.5 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312830risperidone 1 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312831risperidone 2 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312832risperidone 3 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
314211risperidone 4 MG Oral TabletSCDf11dae15-b057-4258-9229-3819d0c980fe16
312828risperiDONE 0.25 MG Oral TabletPSNd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312829risperiDONE 0.5 MG Oral TabletPSNd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312830risperiDONE 1 MG Oral TabletPSNd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312831risperiDONE 2 MG Oral TabletPSNd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312832risperiDONE 3 MG Oral TabletPSNd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
314211risperiDONE 4 MG Oral TabletPSNd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312828risperidone 0.25 MG Oral TabletSCDd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312829risperidone 0.5 MG Oral TabletSCDd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312830risperidone 1 MG Oral TabletSCDd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312831risperidone 2 MG Oral TabletSCDd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312832risperidone 3 MG Oral TabletSCDd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
314211risperidone 4 MG Oral TabletSCDd5abd75f-7f4a-4a7d-b849-82fce88f5ff74
312830risperiDONE 1 MG Oral TabletPSN24a5d048-b351-4df5-89c8-f68147daba883
312831risperiDONE 2 MG Oral TabletPSN24a5d048-b351-4df5-89c8-f68147daba883
312830risperidone 1 MG Oral TabletSCD24a5d048-b351-4df5-89c8-f68147daba883
312831risperidone 2 MG Oral TabletSCD24a5d048-b351-4df5-89c8-f68147daba883
312828risperiDONE 0.25 MG Oral TabletPSN2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312829risperiDONE 0.5 MG Oral TabletPSN2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312830risperiDONE 1 MG Oral TabletPSN2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312831risperiDONE 2 MG Oral TabletPSN2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312832risperiDONE 3 MG Oral TabletPSN2e5c6b7f-1d57-4114-9067-79dca009c4cc1
314211risperiDONE 4 MG Oral TabletPSN2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312828risperidone 0.25 MG Oral TabletSCD2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312829risperidone 0.5 MG Oral TabletSCD2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312830risperidone 1 MG Oral TabletSCD2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312831risperidone 2 MG Oral TabletSCD2e5c6b7f-1d57-4114-9067-79dca009c4cc1
312832risperidone 3 MG Oral TabletSCD2e5c6b7f-1d57-4114-9067-79dca009c4cc1
314211risperidone 4 MG Oral TabletSCD2e5c6b7f-1d57-4114-9067-79dca009c4cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-115-0168382011501100 TABLET, FILM COATED in 1 BOTTLE (68382-115-01) 2008-11-130000-00-00NoNoCurrent
68382-115-0568382011505500 TABLET, FILM COATED in 1 BOTTLE (68382-115-05) 2008-11-130000-00-00NoNoCurrent
68382-115-066838201150630 TABLET, FILM COATED in 1 BOTTLE (68382-115-06) 2008-11-130000-00-00NoNoCurrent
68382-115-10683820115101000 TABLET, FILM COATED in 1 BOTTLE (68382-115-10) 2008-11-130000-00-00NoNoCurrent
68382-115-146838201151460 TABLET, FILM COATED in 1 BOTTLE (68382-115-14) 2008-11-130000-00-00NoNoCurrent
68382-115-166838201151690 TABLET, FILM COATED in 1 BOTTLE (68382-115-16) 2008-11-130000-00-00NoNoCurrent