RISPERIDONE

Product NDC
63187-264
11-digit product format
631870264
Labeler code
63187
Product ID
63187-264_ce66e2ff-3454-4ec4-8caa-a261ab8c283c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-04-23
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
Rxcui312830

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
63187-264-30RISPERIDONE30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-264RISPERIDONE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 1 package rows20221027_088dc3dd-7740-471b-8c06-5a47900ae5b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312830risperiDONE 1 MG Oral TabletPSN088dc3dd-7740-471b-8c06-5a47900ae5b54
312830risperidone 1 MG Oral TabletSCD088dc3dd-7740-471b-8c06-5a47900ae5b54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-264-306318702643030 TABLET in 1 BOTTLE (63187-264-30) 30 tablet2018-12-010000-00-00NoNoCurrent