INVEGA SUSTENNA

Product NDC: 50458-564
11-digit product format: 504580564
Labeler code: 50458
Product ID: 50458-564_2e1c43cb-d27e-b3ac-e063-6394a90ad44a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paliperidone palmitate
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Janssen Pharmaceuticals, Inc.
Application: NDA022264
Marketing category: NDA
Marketing start: 2009-07-31
Substance: PALIPERIDONE PALMITATE
Active strength: 234 mg/1.5mL
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: INVEGA SUSTENNA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALIPERIDONE PALMITATE	234 mg/1.5mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	R8P8USM8FR
Rxcui	858048, 858051, 858052, 858053, 858054, 858055, 858056, 858057, 858073, 858074

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3752075e-d817-45ea-9aa1-8dc0301cf2aa	Product name	1	20251114
893dce58-6330-4a9a-ab03-5ffd7148e184	Product name	1	20250311
b6847380-b533-d626-e29e-10b60b2ad451	Product name	9	20250303
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
fd328049-536a-4914-b42e-93bf4d93db24	Product name	1	20220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69	Product name	2	20220304
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50458-564-01	INVEGA SUSTENNA	1 in 1 KIT	INJECTION	1	41
50458-564-01	INVEGA SUSTENNA	1.5 mL in 1 SYRINGE	INJECTION	1.5	41
50458-564-03	INVEGA SUSTENNA	1.5 mL in 1 SYRINGE	INJECTION	1.5	41
50458-564-03	INVEGA SUSTENNA	1 in 1 KIT	INJECTION	1	41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-564-01	ML - Milliliter	50458-564	ecb24c9e-9003-45ce-86ab-ad1bf6ae328f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
paliperidone palmitate	ACTIVE INGREDIENT	R8P8USM8FR	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19
paliperidone	ACTIVE MOIETY	838F01T721	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19
polyethylene glycol 4000	INACTIVE INGREDIENT	4R4HFI6D95	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19
sodium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	22ADO53M6F	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19
sodium phosphate, monobasic	INACTIVE INGREDIENT	3980JIH2SW	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19
water	INACTIVE INGREDIENT	059QF0KO0R	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-564	INVEGA SUSTENNA (PALIPERIDONE PALMITATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.]	41	Current NDC, Legacy NDC, 4 package rows	20250216_1af14e42-951d-414d-8564-5d5fce138554.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R8P8USM8FR	PALIPERIDONE PALMITATE	199739-10-1	PALIPERIDONE PALMITATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858057	Invega Sustenna 117 MG in 0.75 mL Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858055	Invega Sustenna 156 MG in 1 ML Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858053	Invega Sustenna 234 MG in 1.5 ML Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858074	Invega Sustenna 39 MG in 0.25 mL Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858051	Invega Sustenna 78 MG in 0.5 mL Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858056	paliperidone palmitate 117 MG in 0.75 ML Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858054	paliperidone palmitate 156 MG in 1 ML Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858052	paliperidone palmitate 234 MG in 1.5 ML Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858073	paliperidone palmitate 39 MG in 0.25 ML Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858048	paliperidone palmitate 78 MG in 0.5 ML Prefilled Syringe	PSN	1af14e42-951d-414d-8564-5d5fce138554	41
858074	0.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega]	SBD	1af14e42-951d-414d-8564-5d5fce138554	41
858051	0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega]	SBD	1af14e42-951d-414d-8564-5d5fce138554	41
858057	0.75 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega]	SBD	1af14e42-951d-414d-8564-5d5fce138554	41
858055	1 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega]	SBD	1af14e42-951d-414d-8564-5d5fce138554	41
858053	1.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega]	SBD	1af14e42-951d-414d-8564-5d5fce138554	41
858073	0.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	1af14e42-951d-414d-8564-5d5fce138554	41
858048	0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	1af14e42-951d-414d-8564-5d5fce138554	41
858056	0.75 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	1af14e42-951d-414d-8564-5d5fce138554	41
858054	1 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	1af14e42-951d-414d-8564-5d5fce138554	41
858052	1.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe	SCD	1af14e42-951d-414d-8564-5d5fce138554	41
858074	0.25 ML Invega Sustenna 156 MG/ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858051	0.5 ML Invega Sustenna 156 MG/ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858057	0.75 ML Invega Sustenna 156 MG/ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858055	1 ML Invega Sustenna 156 MG/ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858053	1.5 ML Invega Sustenna 156 MG/ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858057	Invega Sustenna 117 MG per 0.75 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858057	Invega Sustenna 117 MG per 0.75 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858055	Invega Sustenna 156 MG per 1 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858055	Invega Sustenna 156 MG per 1 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858053	Invega Sustenna 234 MG per 1.5 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858053	Invega Sustenna 234 MG per 1.5 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858074	Invega Sustenna 39 MG per 0.25 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858074	Invega Sustenna 39 MG per 0.25 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858051	Invega Sustenna 78 MG per 0.5 ML Extended Release Injectable Suspension in a Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858051	Invega Sustenna 78 MG per 0.5 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858056	paliperidone palmitate 117 MG per 0.75 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858054	paliperidone palmitate 156 MG per 1 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858052	paliperidone palmitate 234 MG per 1.5 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858073	paliperidone palmitate 39 MG per 0.25 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41
858048	paliperidone palmitate 78 MG per 0.5 ML Prefilled Syringe	SY	1af14e42-951d-414d-8564-5d5fce138554	41

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-564-01	50458056401	1 SYRINGE in 1 KIT (50458-564-01) / 1.5 mL in 1 SYRINGE	1 syringe	2009-07-31	0000-00-00	No	No	Current
50458-564-03	50458056403	1 SYRINGE in 1 KIT (50458-564-03) / 1.5 mL in 1 SYRINGE	1 syringe	2009-07-31	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INVEGA SUSTENNA	Janssen Pharmaceuticals, Inc. \| Janssen Pharmaceutica, NV \| Janssen Pharmaceutical Sciences Unlimited Company	2025-02-14	HUMAN PRESCRIPTION DRUG LABEL	41

INVEGA SUSTENNA

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#