Risperidone

Product NDC
59746-226
11-digit product format
597460226
Labeler code
59746
Product ID
59746-226_39d41b28-93eb-446b-9652-7432858ccbab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA078828
Marketing category
ANDA
Marketing start
2025-10-15
Substance
RISPERIDONE
Active strength
4 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
RISPERIDONE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312828, 312829, 312830, 312831, 312832, 314211

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
59746-226-05Risperidone500 in 1 BOTTLETABLET5001
59746-226-60Risperidone60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-226-05EA - Each59746-22676eb82e5-de69-42e6-93a2-ccafffc2900812025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312828risperiDONE 0.25 MG Oral TabletPSN39d41b28-93eb-446b-9652-7432858ccbab1
312829risperiDONE 0.5 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312829risperiDONE 0.5 MG Oral TabletPSN39d41b28-93eb-446b-9652-7432858ccbab1
312830risperiDONE 1 MG Oral TabletPSN39d41b28-93eb-446b-9652-7432858ccbab1
312830risperiDONE 1 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312831risperiDONE 2 MG Oral TabletPSN39d41b28-93eb-446b-9652-7432858ccbab1
312831risperiDONE 2 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312832risperiDONE 3 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312832risperiDONE 3 MG Oral TabletPSN39d41b28-93eb-446b-9652-7432858ccbab1
314211risperiDONE 4 MG Oral TabletPSN39d41b28-93eb-446b-9652-7432858ccbab1
314211risperiDONE 4 MG Oral TabletPSN448467a3-44ef-c87b-e063-6294a90a5ec91
312828risperidone 0.25 MG Oral TabletSCD39d41b28-93eb-446b-9652-7432858ccbab1
312828risperidone 0.25 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
312829risperidone 0.5 MG Oral TabletSCD39d41b28-93eb-446b-9652-7432858ccbab1
312829risperidone 0.5 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
312830risperidone 1 MG Oral TabletSCD39d41b28-93eb-446b-9652-7432858ccbab1
312830risperidone 1 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
312831risperidone 2 MG Oral TabletSCD39d41b28-93eb-446b-9652-7432858ccbab1
312831risperidone 2 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
312832risperidone 3 MG Oral TabletSCD39d41b28-93eb-446b-9652-7432858ccbab1
312832risperidone 3 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91
314211risperidone 4 MG Oral TabletSCD39d41b28-93eb-446b-9652-7432858ccbab1
314211risperidone 4 MG Oral TabletSCD448467a3-44ef-c87b-e063-6294a90a5ec91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59746-226-0559746022605500 TABLET in 1 BOTTLE (59746-226-05) 500 tablet2025-10-15NoNoHistorical
59746-226-605974602266060 TABLET in 1 BOTTLE (59746-226-60) 60 tablet2025-10-15NoNoHistorical