RISPERDAL CONSTA: Package Insert and Label Information (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 25 mg Kit Carton

25 mg Dose Pack

Store Package
in Refrigerator
(see bottom panel for
storage conditions)

Rx only
Single use only

NDC 50458-306-11

RisperdalCONSTA ®
risperiDONE Long-Acting Injection

DOSE PACK CONTENTS:

  • One 25 mg vial of risperidone extended-release microspheres for injection
  • One pre-filled syringe containing 2 mL of diluent
  • One Vial Adapter
  • One 21-gauge UTW 1″ Terumo SurGuard® 3 safety needle for deltoid injection
  • One 20-gauge TW 2″ Terumo SurGuard® 3 safety needle for gluteal injection

Do not substitute any components of the dose pack.

For deltoid or gluteal intramuscular injection only Each injection should be administered by a healthcare professional.

PLEASE READ COMPLETE INSTRUCTIONS PRIOR TO USE.

PRINCIPAL DISPLAY PANEL -- 25 mg Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 37.5 mg Kit Carton

37.5 mg Dose Pack

Store Package
in Refrigerator
(see bottom panel for
storage conditions)

Rx only
Single use only

NDC 50458-307-11

RisperdalCONSTA ®
risperiDONE Long-Acting Injection

DOSE PACK CONTENTS:

  • One 37.5 mg vial of risperidone extended-release microspheres for injection
  • One pre-filled syringe containing 2 mL of diluent
  • One Vial Adapter
  • One 21-gauge UTW 1″ Terumo SurGuard® 3 safety needle for deltoid injection
  • One 20-gauge TW 2″ Terumo SurGuard® 3 safety needle for gluteal injection

Do not substitute any components of the dose pack.

For deltoid or gluteal intramuscular injection only Each injection should be administered by a healthcare professional.

PLEASE READ COMPLETE INSTRUCTIONS PRIOR TO USE.

PRINCIPAL DISPLAY PANEL -- 37.5 mg Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Kit Carton

50 mg Dose Pack

Store Package
in Refrigerator
(see bottom panel for
storage conditions)

Rx only
Single use only

NDC 50458-308-11

RisperdalCONSTA ®
risperiDONE Long-Acting Injection

DOSE PACK CONTENTS:

  • One 50 mg vial of risperidone extended-release microspheres for injection
  • One pre-filled syringe containing 2 mL of diluent
  • One Vial Adapter
  • One 21-gauge UTW 1″ Terumo SurGuard® 3 safety needle for deltoid injection
  • One 20-gauge TW 2″ Terumo SurGuard® 3 safety needle for gluteal injection

Do not substitute any components of the dose pack.

For deltoid or gluteal intramuscular injection only Each injection should be administered by a healthcare professional.

PLEASE READ COMPLETE INSTRUCTIONS PRIOR TO USE.

PRINCIPAL DISPLAY PANEL -- 50 mg Kit Carton
(click image for full-size original)
RISPERDAL CONSTA risperidone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-309
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-309-11 1 KIT in 1 BOX None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 2 mL
Part 2 1 SYRINGE 2 mL
Part 1 of 2
RISPERDAL CONSTA risperidone injection, powder, for suspension, extended release
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
risperidone (risperidone) risperidone 12.5 mg in 2 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
polysorbate 20
carboxymethylcellulose sodium, unspecified form
sodium phosphate, dibasic, heptahydrate
anhydrous citric acid
sodium chloride
sodium hydroxide
water
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
RISPERDAL CONSTA risperidone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-306
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-306-11 1 KIT in 1 BOX None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 2 mL
Part 2 1 SYRINGE 2 mL
Part 1 of 2
RISPERDAL CONSTA risperidone injection, powder, for suspension, extended release
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
risperidone (risperidone) risperidone 25 mg in 2 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
polysorbate 20
carboxymethylcellulose sodium, unspecified form
sodium phosphate, dibasic, heptahydrate
anhydrous citric acid
sodium chloride
sodium hydroxide
water
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
RISPERDAL CONSTA risperidone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-307
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-307-11 1 KIT in 1 BOX None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 2 mL
Part 2 1 SYRINGE 2 mL
Part 1 of 2
RISPERDAL CONSTA risperidone injection, powder, for suspension, extended release
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
risperidone (risperidone) risperidone 37.5 mg in 2 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
polysorbate 20
carboxymethylcellulose sodium, unspecified form
sodium phosphate, dibasic, heptahydrate
anhydrous citric acid
sodium chloride
sodium hydroxide
water
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
RISPERDAL CONSTA risperidone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-308
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-308-11 1 KIT in 1 BOX None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 2 mL
Part 2 1 SYRINGE 2 mL
Part 1 of 2
RISPERDAL CONSTA risperidone injection, powder, for suspension, extended release
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
risperidone (risperidone) risperidone 50 mg in 2 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
polysorbate 20
carboxymethylcellulose sodium, unspecified form
sodium phosphate, dibasic, heptahydrate
anhydrous citric acid
sodium chloride
sodium hydroxide
water
Packaging
# Item Code Package Description Multilevel Packaging
1 2 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021346 10/29/2003
Labeler — Janssen Pharmaceuticals, Inc. (063137772)
Establishment
Name Address ID/FEI Operations
Alkermes, Inc. 858582083 MANUFACTURE (50458-309), MANUFACTURE (50458-306), MANUFACTURE (50458-307), MANUFACTURE (50458-308)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutical Sciences Unlimited Company 985639841 API MANUFACTURE (50458-309), API MANUFACTURE (50458-306), API MANUFACTURE (50458-307), API MANUFACTURE (50458-308)
Establishment
Name Address ID/FEI Operations
Cilag AG 483237103 MANUFACTURE (50458-309), MANUFACTURE (50458-306), MANUFACTURE (50458-307), MANUFACTURE (50458-308)
Establishment
Name Address ID/FEI Operations
Vetter 344217323 MANUFACTURE (50458-309), MANUFACTURE (50458-306), MANUFACTURE (50458-307), MANUFACTURE (50458-308)

Revised: 07/2020 Janssen Pharmaceuticals, Inc.

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