RISPERIDONE

Product NDC
63187-439
11-digit product format
631870439
Labeler code
63187
Product ID
63187-439_9a567a24-6d70-46fd-b24a-2c1a1c2fe5e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-04-23
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
Rxcui312831

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-439-30RISPERIDONE30 in 1 BOTTLETABLET305
63187-439-60RISPERIDONE60 in 1 BOTTLETABLET605
63187-439-90RISPERIDONE90 in 1 BOTTLETABLET905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
63187-439RISPERIDONE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20221021_2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312831risperiDONE 2 MG Oral TabletPSN2b9cce47-b8b3-4c9b-b26a-3d742a0db8e25
312831risperidone 2 MG Oral TabletSCD2b9cce47-b8b3-4c9b-b26a-3d742a0db8e25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-439-306318704393030 TABLET in 1 BOTTLE (63187-439-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-439-606318704396060 TABLET in 1 BOTTLE (63187-439-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-439-906318704399090 TABLET in 1 BOTTLE (63187-439-90) 90 tablet2018-12-010000-00-00NoNoCurrent