FDA.reportPublic FDA data

RISPERIDONE

Product NDC
55648-571
11-digit product format
556480571
Labeler code
55648
Product ID
55648-571_aaa62d0c-37d5-40a9-8940-2f2b7397197f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA078871
Marketing category
ANDA
Marketing start
2008-10-09
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-571-012020-01-31C16284748780-19d75b9d0-3af9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Tablets Initial U.S. Approval : 1993
55648-571-022020-01-31C16284748780-19d75b9d0-3af9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Tablets Initial U.S. Approval : 1993
55648-571-032020-01-31C16284748780-19d75b9d0-3af9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Tablets Initial U.S. Approval : 1993
55648-571-042020-01-31C16284748780-19d75b9d0-3af9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use risperidone safely and effectively. See full prescribing information for risperidone. Risperidone Tablets Initial U.S. Approval : 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-571-01RISPERIDONE30 in 1 BOTTLETABLET, FILM COATED302
55648-571-02RISPERIDONE500 in 1 BOTTLETABLET, FILM COATED5002
55648-571-03RISPERIDONE100 in 1 CARTONTABLET, FILM COATED1002
55648-571-03RISPERIDONE10 in 1 BLISTER PACKTABLET, FILM COATED102
55648-571-04RISPERIDONE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-571RISPERIDONE TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 5 package rows20121019_e92a97ef-0fe3-40b1-a938-373293a75255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312829risperiDONE 0.5 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312830risperiDONE 1 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312831risperiDONE 2 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312832risperiDONE 3 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
314211risperiDONE 4 MG Oral TabletPSNe92a97ef-0fe3-40b1-a938-373293a752552
312828risperidone 0.25 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
312829risperidone 0.5 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
312830risperidone 1 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
312831risperidone 2 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
312832risperidone 3 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552
314211risperidone 4 MG Oral TabletSCDe92a97ef-0fe3-40b1-a938-373293a752552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-571-015564805710130 in 1 BOTTLEHistorical
55648-571-0255648057102500 in 1 BOTTLEHistorical
55648-571-0355648057103100 in 1 CARTONHistorical
55648-571-045564805710460 in 1 BOTTLEHistorical