risperidone

Product NDC
64725-0113
11-digit product format
647250113
Labeler code
64725
Product ID
64725-0113_271f3da1-d81a-4938-94bd-84486e946655
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA078040
Marketing category
ANDA
Marketing start
2008-11-13
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0113-1risperidone60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0113RISPERIDONE TABLET, FILM COATED [TYA PHARMACEUTICALS]4Legacy NDC, 1 package rows20140902_10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312829risperiDONE 0.5 MG Oral TabletPSN10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c4
312830risperiDONE 1 MG Oral TabletPSN10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c4
312829risperidone 0.5 MG Oral TabletSCD10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c4
312830risperidone 1 MG Oral TabletSCD10bf6ea7-fc6d-4cf1-8074-f80f6af9cf5c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0113-16472501130160 in 1 BOTTLEHistorical