risperidone

Product NDC
63187-418
11-digit product format
631870418
Labeler code
63187
Product ID
63187-418_71435439-971d-4db3-89d2-71b74b10f57c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
risperidone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078040
Marketing category
ANDA
Marketing start
2008-11-13
Substance
RISPERIDONE
Active strength
.25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
L6UH7ZF8HCRISPERIDONE106266-06-2RISPERIDONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63187-418-606318704186060 TABLET, FILM COATED in 1 BOTTLE (63187-418-60) 2019-01-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
risperidoneProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL3