FDA.reportPublic FDA data

Risperidone

Product NDC
63304-949
11-digit product format
633040949
Labeler code
63304
Product ID
63304-949_8c155c45-e5c8-4358-90da-8f6d193ad88b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077542
Marketing category
ANDA
Marketing start
2010-08-06
Substance
RISPERIDONE
Active strength
.5 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
RISPERIDONE.5 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-949-05Risperidone500 in 1 BOTTLETABLET, ORALLY DISINTEGRATING50011
63304-949-11Risperidone1 in 1 POUCHTABLET, ORALLY DISINTEGRATING111
63304-949-17Risperidone10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1011
63304-949-30Risperidone30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISPERIDONEACTIVE INGREDIENTL6UH7ZF8HCRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
RISPERIDONEACTIVE MOIETYL6UH7ZF8HCRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
MENTHOLINACTIVE INGREDIENTL7T10EIP3ARISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYRISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1URISPERIDONE TABLET, ORALLY DISINTEGRATING [RANBAXY PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-949RISPERIDONE TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 4 package rows20220716_f91f551e-926f-440d-83d2-357e9d7484fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403825risperiDONE 0.5 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
401953risperiDONE 1 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
401954risperiDONE 2 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
616698risperiDONE 3 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
616705risperiDONE 4 MG Disintegrating Oral TabletPSNf91f551e-926f-440d-83d2-357e9d7484fe11
403825risperidone 0.5 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11
401953risperidone 1 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11
401954risperidone 2 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11
616698risperidone 3 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11
616705risperidone 4 MG Disintegrating Oral TabletSCDf91f551e-926f-440d-83d2-357e9d7484fe11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-949-0563304094905500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-949-05) 2010-08-060000-00-00NoNoCurrent
63304-949-11633040949111 in 1 POUCHHistorical
63304-949-176330409491710 POUCH in 1 BOX, UNIT-DOSE (63304-949-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-949-11) 10 pouch2010-08-060000-00-00NoNoCurrent
63304-949-306330409493030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-949-30) 2010-08-060000-00-00NoNoCurrent