FDA.reportPublic FDA data

Risperidone

Product NDC
59746-020
11-digit product format
597460020
Labeler code
59746
Product ID
59746-020_90b80768-87f7-4fb1-8142-909dba9555e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA090839
Marketing category
ANDA
Marketing start
2011-11-04
Substance
RISPERIDONE
Active strength
1 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
RISPERIDONE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui401953, 401954, 403825, 616698, 616705

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
59746-020-222023-02-28C16284748780-1f386c64a-099c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets, for oral use Initial U.S. Approval: 1993
59746-020-222023-02-28C16284748780-1f386c64a-099c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets, for oral use Initial U.S. Approval: 1993
59746-020-322023-02-28C16284748780-1f386c64a-099c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets, for oral use Initial U.S. Approval: 1993
59746-020-322023-02-28C16284748780-1f386c64a-099c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets, for oral use Initial U.S. Approval: 1993
59746-020-222023-01-30C16284748780-1f386c64a-099c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets, for oral use Initial U.S. Approval: 1993
59746-020-222023-01-30C16284748780-1f386c64a-099c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets, for oral use Initial U.S. Approval: 1993
59746-020-322023-01-30C16284748780-1f386c64a-099c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets, for oral use Initial U.S. Approval: 1993
59746-020-322023-01-30C16284748780-1f386c64a-099c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RISPERIDONE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for RISPERIDONE ORALLY DISINTEGRATING TABLETS. RISPERIDONE orally disintegrating tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-020-22Risperidone7 in 1 CARTONTABLET, ORALLY DISINTEGRATING725
59746-020-22Risperidone4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING425
59746-020-32Risperidone3 in 1 CARTONTABLET, ORALLY DISINTEGRATING325
59746-020-32Risperidone10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-020-22EA - Each59746-02092b5e737-5b65-4b40-a385-7189b9eea2d112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RisperidoneACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
RisperidoneACTIVE MOIETYL6UH7ZF8HCRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G9RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
AspartameINACTIVE INGREDIENTZ0H242BBR1RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerINACTIVE INGREDIENT905HNO1SIHRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Hydroxypropyl Cellulose, Low SubstitutedINACTIVE INGREDIENT2165RE0K14RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Magnesium Aluminometasilicate Type I-aINACTIVE INGREDIENT7LVU907546RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
MannitolINACTIVE INGREDIENT3OWL53L36ARISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
PeppermintINACTIVE INGREDIENTV95R5KMY2BRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
Sodium Stearyl FumarateINACTIVE INGREDIENT7CV7WJK4UIRISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11
TalcINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE (RISPERIDONE) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-020RISPERIDONE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACUTICALS INC.]24Current NDC, Legacy NDC, 4 package rows20250519_739dcf8a-ed73-5eb0-899b-7e51cb73c335.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403825risperiDONE 0.5 MG Disintegrating Oral TabletPSN739dcf8a-ed73-5eb0-899b-7e51cb73c33525
401953risperiDONE 1 MG Disintegrating Oral TabletPSN739dcf8a-ed73-5eb0-899b-7e51cb73c33525
401954risperiDONE 2 MG Disintegrating Oral TabletPSN739dcf8a-ed73-5eb0-899b-7e51cb73c33525
616698risperiDONE 3 MG Disintegrating Oral TabletPSN739dcf8a-ed73-5eb0-899b-7e51cb73c33525
616705risperiDONE 4 MG Disintegrating Oral TabletPSN739dcf8a-ed73-5eb0-899b-7e51cb73c33525
403825risperidone 0.5 MG Disintegrating Oral TabletSCD739dcf8a-ed73-5eb0-899b-7e51cb73c33525
401953risperidone 1 MG Disintegrating Oral TabletSCD739dcf8a-ed73-5eb0-899b-7e51cb73c33525
401954risperidone 2 MG Disintegrating Oral TabletSCD739dcf8a-ed73-5eb0-899b-7e51cb73c33525
616698risperidone 3 MG Disintegrating Oral TabletSCD739dcf8a-ed73-5eb0-899b-7e51cb73c33525
616705risperidone 4 MG Disintegrating Oral TabletSCD739dcf8a-ed73-5eb0-899b-7e51cb73c33525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-020-22597460020227 BLISTER PACK in 1 CARTON (59746-020-22) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK7 blister pack2011-11-040000-00-00NoNoCurrent
59746-020-32597460020323 BLISTER PACK in 1 CARTON (59746-020-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2011-11-040000-00-00NoNoCurrent