Risperidone

Product NDC
0054-0063
11-digit product format
000540063
Labeler code
0054
Product ID
0054-0063_151ddfd0-d116-4f92-80d4-567624ccb0da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risperidone
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076904
Marketing category
ANDA
Marketing start
2009-07-29
Marketing end
0000-00-00
Substance
RISPERIDONE
Active strength
1 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0063-44ML - Milliliter0054-0063e996c58e-be8d-4162-ab55-4cb580fb56d012012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0063-440005400634430 mL in 1 BOTTLE (0054-0063-44) 30 ml2009-07-290000-00-00NoNoCurrent