20 mg Injectable Suspension Label
NDC 12496-0120-2
once-monthly
PERSERIS™
(risperidone)
for extended-release
injectable suspension
120 mg
For abdominal subcutaneous
injection only.
Please read complete
instructions prior to use.
Please see accompanying
Full Prescribing Information.
Rx only
Sterile
Single-dose only
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PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 120 mg Delivery System Label
NDC 12496-0776-2
Delivery System
for PERSERIS™ 120 mg
For abdominal subcutaneous
injection only.
Please read complete
instructions prior to use.
Please see accompanying
Full Prescribing Information.
Rx only
Sterile
Single-dose only
Principal Display Panel - Perseris Kit 120 mg Delivery System Label
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PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 120 mg Syringe Label
NDC 12496-0120-5
Rx only
Sterile
PERSERIS™
(risperidone)
For abdominal
subcutaneous
injection only.
120 mg
Powder
Syringe
Principal Display Panel - Perseris Kit 120 mg Syringe Label
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PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 120 mg Delivery System Label
NDC 12496-0776-5
Rx only
Sterile
Delivery System
for PERSERIS™ 120 mg
For abdominal
subcutaneous
injection only.
Liquid
Syringe
Principal Display Panel - Perseris Kit 120 mg Delivery System Label
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INGREDIENTS AND APPEARANCE
PERSERIS
risperidone kit
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12496-0090
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12496-0090-1 1 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 11/19/2018
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 SYRINGE 1.2 mL
Part 2 1 SYRINGE 1 mL
Part 1 of 2
PERSERIS
risperidone powder
PRODUCT INFORMATION
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Risperidone (UNII: L6UH7ZF8HC) (Risperidone - UNII:L6UH7ZF8HC) Risperidone 90 mg in 0.6 mL
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 POUCH
1 1.2 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/19/2018
Part 2 of 2
DELIVERY SYSTEM
poly(dl-lactic-co-glycolic acid), (50:50; 46000 mw), methylpyrrolidone liquid
PRODUCT INFORMATION
Item Code (Source) NDC:12496-0589
Route of Administration SUBCUTANEOUS
INACTIVE INGREDIENTS
Ingredient Name Strength
Poly(DL-lactic-co-glycolic acid), (50:50; 46000 MW) (UNII: LQ35R50VR1)
Methylpyrrolidone (UNII: JR9CE63FPM)&nb |
