FDA.reportPublic FDA data

Risperidone

Product NDC
70518-3883
11-digit product format
705183883
Labeler code
70518
Product ID
70518-3883_3f8d40d3-5ef2-b9aa-e063-6294a90a463b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077493
Marketing category
ANDA
Marketing start
2023-09-28
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
42b1a2d5-888a-4386-ab9f-0979e0d7b4aaProduct name120231010
66685e90-862d-4873-a0c5-2be73b803c36Product name120230921
92d220a1-2a4c-4393-9080-7335ca8223ccProduct name120230823
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3883-0Risperidone30 in 1 BLISTER PACKTABLET305
70518-3883-1Risperidone60 in 1 BLISTER PACKTABLET605
70518-3883-2Risperidone30 in 1 BLISTER PACKTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3883RISPERIDONE TABLET [REMEDYREPACK INC.]4Current NDC, 3 package rows20250124_c84807bd-35d7-4138-8989-42617d69293a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312830risperiDONE 1 MG Oral TabletPSNc84807bd-35d7-4138-8989-42617d69293a5
312830risperidone 1 MG Oral TabletSCDc84807bd-35d7-4138-8989-42617d69293a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3883-07051838830030 TABLET in 1 BLISTER PACK (70518-3883-0) 30 tablet2023-09-28NoNoCurrent
70518-3883-17051838830160 TABLET in 1 BLISTER PACK (70518-3883-1) 60 tablet2023-09-28NoNoCurrent
70518-3883-27051838830230 TABLET in 1 BLISTER PACK (70518-3883-2) 30 tablet2025-01-22NoNoCurrent