RISPERIDONE

Product NDC
63187-439
11-digit product format
631870439
Labeler code
63187
Product ID
63187-439_9a567a24-6d70-46fd-b24a-2c1a1c2fe5e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RISPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201003
Marketing category
ANDA
Marketing start
2014-04-23
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
L6UH7ZF8HCRISPERIDONE106266-06-2RISPERIDONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63187-439-306318704393030 TABLET in 1 BOTTLE (63187-439-30) 30 tablet2018-12-01NoNoHistorical
63187-439-606318704396060 TABLET in 1 BOTTLE (63187-439-60) 60 tablet2018-12-01NoNoHistorical
63187-439-906318704399090 TABLET in 1 BOTTLE (63187-439-90) 90 tablet2018-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RISPERIDONEProficient Rx LP2022-10-01HUMAN PRESCRIPTION DRUG LABEL5