FDA.reportPublic FDA data

Risperidone

Product NDC
49884-311
11-digit product format
498840311
Labeler code
49884
Product ID
49884-311_3bd8b953-b579-4044-a5e7-b07d113738d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA077494
Marketing category
ANDA
Marketing start
2009-06-01
Substance
RISPERIDONE
Active strength
.5 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
RISPERIDONE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui401953, 401954, 403825, 616698, 616705, 645037

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-311-552022-09-27C16284748780-1e4f33bdf-a4d4-d8a0-e053-dadaa90a6e4eThese 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 Initial U.S. Approval: 1993
49884-311-912022-09-27C16284748780-1e4f33bdf-a4d4-d8a0-e053-dadaa90a6e4eThese 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 Initial U.S. Approval: 1993
49884-311-552022-07-29C16284748780-1e4f33bdf-a4d4-d8a0-e053-dadaa90a6e4eThese 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 Initial U.S. Approval: 1993
49884-311-912022-07-29C16284748780-1e4f33bdf-a4d4-d8a0-e053-dadaa90a6e4eThese 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 Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-311-52Risperidone4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING432
49884-311-55Risperidone6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING632
49884-311-55Risperidone5 in 1 CARTONTABLET, ORALLY DISINTEGRATING532
49884-311-91Risperidone7 in 1 CARTONTABLET, ORALLY DISINTEGRATING732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-311RISPERIDONE TABLET, ORALLY DISINTEGRATING [ENDO USA, INC.]28Current NDC, Legacy NDC, 4 package rows20250524_d0ef6df3-67e5-47b1-bcf7-f67aa030caca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645037risperiDONE 0.25 MG Disintegrating Oral TabletPSNd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
403825risperiDONE 0.5 MG Disintegrating Oral TabletPSNd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
401953risperiDONE 1 MG Disintegrating Oral TabletPSNd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
401954risperiDONE 2 MG Disintegrating Oral TabletPSNd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
616698risperiDONE 3 MG Disintegrating Oral TabletPSNd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
616705risperiDONE 4 MG Disintegrating Oral TabletPSNd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
645037risperidone 0.25 MG Disintegrating Oral TabletSCDd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
403825risperidone 0.5 MG Disintegrating Oral TabletSCDd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
401953risperidone 1 MG Disintegrating Oral TabletSCDd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
401954risperidone 2 MG Disintegrating Oral TabletSCDd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
616698risperidone 3 MG Disintegrating Oral TabletSCDd0ef6df3-67e5-47b1-bcf7-f67aa030caca32
616705risperidone 4 MG Disintegrating Oral TabletSCDd0ef6df3-67e5-47b1-bcf7-f67aa030caca32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-311-52498840311524 in 1 BLISTER PACKHistorical
49884-311-55498840311555 BLISTER PACK in 1 CARTON (49884-311-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2009-06-010000-00-00NoNoCurrent
49884-311-91498840311917 BLISTER PACK in 1 CARTON (49884-311-91) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-311-52) 7 blister pack2009-06-010000-00-00NoNoCurrent