RISPERIDONE

Product NDC
42495-004
11-digit product format
424950004
Labeler code
42495
Product ID
42495-004_43505d96-c582-433e-9bba-d19593dfa839
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
MSM Repackaging
Application
ANDA201003
Marketing category
ANDA
Marketing start
2015-09-09
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
2 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
42495-004-30RISPERIDONE30 in 1 BLISTER PACKTABLET303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42495-004RISPERIDONE TABLET [MSM REPACKAGING]3Legacy NDC, 1 package rows20151014_c2e47d77-6919-44b1-bec0-c410f70a0ebf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312831risperiDONE 2 MG Oral TabletPSNc2e47d77-6919-44b1-bec0-c410f70a0ebf3
312831risperidone 2 MG Oral TabletSCDc2e47d77-6919-44b1-bec0-c410f70a0ebf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42495-004-304249500043030 in 1 BLISTER PACKHistorical