Risperidone

Product NDC
71610-259
11-digit product format
716100259
Labeler code
71610
Product ID
71610-259_d100ecbc-bf31-4407-a2d6-203a429375c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077493
Marketing category
ANDA
Marketing start
2015-06-01
Substance
RISPERIDONE
Active strength
2 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
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
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
71610-259-15Risperidone15 in 1 BOTTLETABLET151
71610-259-30Risperidone30 in 1 BOTTLETABLET301
71610-259-45Risperidone45 in 1 BOTTLETABLET451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-259-15EA - Each71610-259891e60c1-6c21-4e10-a6d9-948a6bef17ef12019-06-19
71610-259-30EA - Each71610-259a51f9e9c-3117-45cf-84d6-27b5bf2ce22b12019-06-19
71610-259-45EA - Each71610-259aa74d26c-94fb-4f7b-88ec-abdf55bd441a12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-259RISPERIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20190424_58e422ec-da66-41b0-83c1-aefd940beda0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312831risperiDONE 2 MG Oral TabletPSN58e422ec-da66-41b0-83c1-aefd940beda01
312831risperidone 2 MG Oral TabletSCD58e422ec-da66-41b0-83c1-aefd940beda01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-259-157161002591515 TABLET in 1 BOTTLE (71610-259-15) 15 tablet2019-04-030000-00-00NoNoCurrent
71610-259-307161002593030 TABLET in 1 BOTTLE (71610-259-30) 30 tablet2019-04-030000-00-00NoNoCurrent
71610-259-457161002594545 TABLET in 1 BOTTLE (71610-259-45) 45 tablet2019-04-030000-00-00NoNoCurrent