INVEGA SUSTENNA
These highlights do not include all the information needed to use INVEGA SUSTENNA safely and effectively. See full prescribing information for INVEGA SUSTENNA. INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable suspension, for intramuscular use Initial U.S. Approval: 2006
Approved
Approval ID
1af14e42-951d-414d-8564-5d5fce138554
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2022
Manufacturers
FDA
Janssen Pharmaceuticals, Inc.
DUNS: 063137772
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
paliperidone palmitate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50458-563
Application NumberNDA022264
Product Classification
M
Marketing Category
C73594
G
Generic Name
paliperidone palmitate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (8)
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
paliperidone palmitateActive
Quantity: 156 mg in 1 mL
Code: R8P8USM8FR
Classification: ACTIB
polyethylene glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
sodium phosphate, dibasic, anhydrousInactive
Code: 22ADO53M6F
Classification: IACT
sodium phosphate, monobasic, unspecified formInactive
Code: 3980JIH2SW
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
paliperidone palmitate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50458-560
Application NumberNDA022264
Product Classification
M
Marketing Category
C73594
G
Generic Name
paliperidone palmitate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (8)
paliperidone palmitateActive
Quantity: 39 mg in 0.25 mL
Code: R8P8USM8FR
Classification: ACTIB
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
sodium phosphate, dibasic, anhydrousInactive
Code: 22ADO53M6F
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
sodium phosphate, monobasic, unspecified formInactive
Code: 3980JIH2SW
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
polyethylene glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
paliperidone palmitate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50458-564
Application NumberNDA022264
Product Classification
M
Marketing Category
C73594
G
Generic Name
paliperidone palmitate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (8)
polyethylene glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
sodium phosphate, dibasic, anhydrousInactive
Code: 22ADO53M6F
Classification: IACT
paliperidone palmitateActive
Quantity: 234 mg in 1.5 mL
Code: R8P8USM8FR
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
sodium phosphate, monobasic, unspecified formInactive
Code: 3980JIH2SW
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
paliperidone palmitate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50458-562
Application NumberNDA022264
Product Classification
M
Marketing Category
C73594
G
Generic Name
paliperidone palmitate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (8)
paliperidone palmitateActive
Quantity: 117 mg in 0.75 mL
Code: R8P8USM8FR
Classification: ACTIB
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
sodium phosphate, dibasic, anhydrousInactive
Code: 22ADO53M6F
Classification: IACT
polyethylene glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
sodium phosphate, monobasic, unspecified formInactive
Code: 3980JIH2SW
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
paliperidone palmitate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50458-561
Application NumberNDA022264
Product Classification
M
Marketing Category
C73594
G
Generic Name
paliperidone palmitate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (8)
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
sodium phosphate, monobasic, unspecified formInactive
Code: 3980JIH2SW
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
paliperidone palmitateActive
Quantity: 78 mg in 0.5 mL
Code: R8P8USM8FR
Classification: ACTIB
polyethylene glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
sodium phosphate, dibasic, anhydrousInactive
Code: 22ADO53M6F
Classification: IACT