FDA.reportPublic FDA data

RISPERIDONE

Product NDC
70518-0364
11-digit product format
705180364
Labeler code
70518
Product ID
70518-0364_5257c6b8-5d9d-1918-e063-6394a90a3cbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201003
Marketing category
ANDA
Marketing start
2017-03-27
Substance
RISPERIDONE
Active strength
1 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
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
70518-0364-0RISPERIDONE30 in 1 BLISTER PACKTABLET3024
70518-0364-1RISPERIDONE30 in 1 BLISTER PACKTABLET3024
70518-0364-2RISPERIDONE30 in 1 BOTTLE, PLASTICTABLET3024
70518-0364-3RISPERIDONE50 in 1 BOXTABLET5024
70518-0364-4RISPERIDONE1 in 1 POUCHTABLET124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0364RISPERIDONE TABLET [REMEDYREPACK INC.]18Current NDC, Legacy NDC, 5 package rows20250426_03d3b52d-3a7d-4595-84c9-332da6ca9171.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312830risperiDONE 1 MG Oral TabletPSN03d3b52d-3a7d-4595-84c9-332da6ca917124
312830risperidone 1 MG Oral TabletSCD03d3b52d-3a7d-4595-84c9-332da6ca917124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0364-07051803640030 TABLET in 1 BLISTER PACK (70518-0364-0) 30 tablet2017-03-270000-00-00NoNoCurrent
70518-0364-17051803640130 TABLET in 1 BLISTER PACK (70518-0364-1) 30 tablet2021-04-300000-00-00NoNoCurrent
70518-0364-27051803640230 TABLET in 1 BOTTLE, PLASTIC (70518-0364-2) 30 tablet2025-08-22NoNoHistorical
70518-0364-37051803640350 POUCH in 1 BOX (70518-0364-3) / 1 TABLET in 1 POUCH (70518-0364-4) 50 pouch2026-05-21NoNoHistorical
70518-0364-4705180364041 in 1 POUCHHistorical