RISPERIDONE

Product NDC
72789-461
11-digit product format
727890461
Labeler code
72789
Product ID
72789-461_4db273b0-d906-4596-e063-6394a90a57db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-03-28
Substance
RISPERIDONE
Active strength
2 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
RISPERIDONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312831

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
72789-461-14RISPERIDONE14 in 1 BOTTLE, PLASTICTABLET1419

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-461RISPERIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]18Current NDC, 1 package rows20250503_bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312831risperiDONE 2 MG Oral TabletPSNbdb08381-dbfc-442e-8d3c-22d3a0f2f6c519
312831risperidone 2 MG Oral TabletSCDbdb08381-dbfc-442e-8d3c-22d3a0f2f6c519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-461-147278904611414 TABLET in 1 BOTTLE, PLASTIC (72789-461-14) 14 tablet2024-12-23NoNoCurrent