FDA.reportPublic FDA data

RISPERIDONE

Product NDC
71205-520
11-digit product format
712050520
Labeler code
71205
Product ID
71205-520_be1f8d5f-876a-4c16-b504-8812d781e06d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-03-28
Substance
RISPERIDONE
Active strength
.25 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.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312828

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
71205-520-30RISPERIDONE30 in 1 BOTTLETABLET302
71205-520-60RISPERIDONE60 in 1 BOTTLETABLET602
71205-520-90RISPERIDONE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-520-30EA - Each71205-520a94c28e7-2e4c-434b-a244-1423257b2f8512021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-520RISPERIDONE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220626_394c7e27-52a2-4d4c-8c6e-fe37b03266ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312828risperiDONE 0.25 MG Oral TabletPSN394c7e27-52a2-4d4c-8c6e-fe37b03266ae2
312828risperidone 0.25 MG Oral TabletSCD394c7e27-52a2-4d4c-8c6e-fe37b03266ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-520-307120505203030 TABLET in 1 BOTTLE (71205-520-30) 30 tablet2021-01-050000-00-00NoNoCurrent
71205-520-607120505206060 TABLET in 1 BOTTLE (71205-520-60) 60 tablet2021-01-050000-00-00NoNoCurrent
71205-520-907120505209090 TABLET in 1 BOTTLE (71205-520-90) 90 tablet2021-01-050000-00-00NoNoCurrent