FDA.reportPublic FDA data

RISPERIDONE

Product NDC
50090-3340
11-digit product format
500903340
Labeler code
50090
Product ID
50090-3340_7a6b82ee-cd80-4f86-81c4-5054fe273f0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RISPERIDONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISPERIDONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312828, 312829, 312830, 312831

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
50090-3340-02023-02-07C16284748780-1f386c64a-4203-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993
50090-3340-02023-01-30C16284748780-1f386c64a-4203-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3340-0RISPERIDONE30 in 1 BOTTLETABLET3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3340RISPERIDONE TABLET [A-S MEDICATION SOLUTIONS]20Current NDC, Legacy NDC, 1 package rows20230208_a6767972-2d3f-482b-80bd-ac93e28fdd05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3340-05009033400030 TABLET in 1 BOTTLE (50090-3340-0) 30 tablet2018-01-220000-00-00NoNoCurrent