FDA.reportPublic FDA data

RISPERIDONE

Product NDC
27241-004
11-digit product format
272410004
Labeler code
27241
Product ID
27241-004_8ace73a4-053e-4bd8-ad32-b05807e2f6f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-03-28
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-004-06RISPERIDONE60 in 1 BOTTLETABLET6018
27241-004-50RISPERIDONE500 in 1 BOTTLETABLET50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-004-06EA - Each27241-00489541236-7edc-4a68-9f3b-8904432d096312014-06-03
27241-004-50EA - Each27241-0040fc0540e-2abf-422e-8027-dc568c882c1212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [AJANTA PHARMA LIMITED]5
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [MSM REPACKAGING]3
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [MSM REPACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET [MSM REPACKAGING]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [MSM REPACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET [MSM REPACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET [MSM REPACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [MSM REPACKAGING]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET [MSM REPACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [MSM REPACKAGING]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET [MSM REPACKAGING]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RISPERIDONE TABLET [MSM REPACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [MSM REPACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [MSM REPACKAGING]3
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET [PROFICIENT RX LP]2
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET [PROFICIENT RX LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET [PROFICIENT RX LP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RISPERIDONE TABLET [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-004RISPERIDONE TABLET [AJANTA PHARMA USA INC.]17Current NDC, Legacy NDC, 2 package rows20250406_095630bd-a77e-434e-94ee-f13da445d8f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312831risperiDONE 2 MG Oral TabletPSN420cfeef-0061-43b9-9491-dbd6ad866e55102
312831risperidone 2 MG Oral TabletSCD420cfeef-0061-43b9-9491-dbd6ad866e55102
312828risperiDONE 0.25 MG Oral TabletPSNa6767972-2d3f-482b-80bd-ac93e28fdd0522
312829risperiDONE 0.5 MG Oral TabletPSNa6767972-2d3f-482b-80bd-ac93e28fdd0522
312830risperiDONE 1 MG Oral TabletPSNa6767972-2d3f-482b-80bd-ac93e28fdd0522
312831risperiDONE 2 MG Oral TabletPSNa6767972-2d3f-482b-80bd-ac93e28fdd0522
312828risperidone 0.25 MG Oral TabletSCDa6767972-2d3f-482b-80bd-ac93e28fdd0522
312829risperidone 0.5 MG Oral TabletSCDa6767972-2d3f-482b-80bd-ac93e28fdd0522
312830risperidone 1 MG Oral TabletSCDa6767972-2d3f-482b-80bd-ac93e28fdd0522
312831risperidone 2 MG Oral TabletSCDa6767972-2d3f-482b-80bd-ac93e28fdd0522
312831risperiDONE 2 MG Oral TabletPSNbdb08381-dbfc-442e-8d3c-22d3a0f2f6c519
312831risperidone 2 MG Oral TabletSCDbdb08381-dbfc-442e-8d3c-22d3a0f2f6c519
312828risperiDONE 0.25 MG Oral TabletPSN095630bd-a77e-434e-94ee-f13da445d8f218
312829risperiDONE 0.5 MG Oral TabletPSN095630bd-a77e-434e-94ee-f13da445d8f218
312830risperiDONE 1 MG Oral TabletPSN095630bd-a77e-434e-94ee-f13da445d8f218
312831risperiDONE 2 MG Oral TabletPSN095630bd-a77e-434e-94ee-f13da445d8f218
312832risperiDONE 3 MG Oral TabletPSN095630bd-a77e-434e-94ee-f13da445d8f218
314211risperiDONE 4 MG Oral TabletPSN095630bd-a77e-434e-94ee-f13da445d8f218
312828risperidone 0.25 MG Oral TabletSCD095630bd-a77e-434e-94ee-f13da445d8f218
312829risperidone 0.5 MG Oral TabletSCD095630bd-a77e-434e-94ee-f13da445d8f218
312830risperidone 1 MG Oral TabletSCD095630bd-a77e-434e-94ee-f13da445d8f218
312831risperidone 2 MG Oral TabletSCD095630bd-a77e-434e-94ee-f13da445d8f218
312832risperidone 3 MG Oral TabletSCD095630bd-a77e-434e-94ee-f13da445d8f218
314211risperidone 4 MG Oral TabletSCD095630bd-a77e-434e-94ee-f13da445d8f218
312831risperiDONE 2 MG Oral TabletPSN5d9519af-5a5e-47ce-8a0f-9b9cfac00e1915
312831risperidone 2 MG Oral TabletSCD5d9519af-5a5e-47ce-8a0f-9b9cfac00e1915
312831risperiDONE 2 MG Oral TabletPSN2b9cce47-b8b3-4c9b-b26a-3d742a0db8e25
312831risperidone 2 MG Oral TabletSCD2b9cce47-b8b3-4c9b-b26a-3d742a0db8e25
312831risperiDONE 2 MG Oral TabletPSN79648a52-1364-c25b-e053-2a91aa0a8ea44
312831risperidone 2 MG Oral TabletSCD79648a52-1364-c25b-e053-2a91aa0a8ea44
312831risperiDONE 2 MG Oral TabletPSNc2e47d77-6919-44b1-bec0-c410f70a0ebf3
312831risperidone 2 MG Oral TabletSCDc2e47d77-6919-44b1-bec0-c410f70a0ebf3
312831risperiDONE 2 MG Oral TabletPSNac152803-d75f-4c3c-bc49-8663b21a3a821
312831risperiDONE 2 MG Oral TabletPSNdf611d6c-1919-436a-e053-2a95a90aadc51
312831risperidone 2 MG Oral TabletSCDac152803-d75f-4c3c-bc49-8663b21a3a821
312831risperidone 2 MG Oral TabletSCDdf611d6c-1919-436a-e053-2a95a90aadc51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-004-062724100040660 TABLET in 1 BOTTLE (27241-004-06) 60 tablet2014-03-280000-00-00NoNoCurrent
27241-004-5027241000450500 TABLET in 1 BOTTLE (27241-004-50) 500 tablet2014-03-280000-00-00NoNoCurrent