Risperidone

Product NDC
70518-4426
11-digit product format
705184426
Labeler code
70518
Product ID
70518-4426_3bb76a8d-e1db-b885-e063-6294a90a0395
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077493
Marketing category
ANDA
Marketing start
2025-08-06
Substance
RISPERIDONE
Active strength
3 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
RISPERIDONE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL6UH7ZF8HC
Rxcui312832

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4426-0Risperidone30 in 1 BLISTER PACKTABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312832risperiDONE 3 MG Oral TabletPSN339ec0af-c0f0-4115-8cdb-8f052e633f471
312832risperidone 3 MG Oral TabletSCD339ec0af-c0f0-4115-8cdb-8f052e633f471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4426-07051844260030 TABLET in 1 BLISTER PACK (70518-4426-0) 30 tablet2025-08-06NoNoHistorical