FDA.reportPublic FDA data

INVEGA

Product NDC
50458-550
11-digit product format
504580550
Labeler code
50458
Product ID
50458-550_3c5e5b30-a841-4dfe-88ce-361806c9275f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paliperidone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA021999
Marketing category
NDA
Marketing start
2006-12-19
Substance
PALIPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
INVEGA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PALIPERIDONE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii838F01T721
Rxcui672567, 672569, 672571, 686441, 686443, 686445, 866103, 866105

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3752075e-d817-45ea-9aa1-8dc0301cf2aaProduct name120251114
893dce58-6330-4a9a-ab03-5ffd7148e184Product name120250311
b6847380-b533-d626-e29e-10b60b2ad451Product name920250303
fd328049-536a-4914-b42e-93bf4d93db24Product name120220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69Product name220220304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-550-01INVEGA30 in 1 BOTTLETABLET, EXTENDED RELEASE3043
50458-550-10INVEGA10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1043
50458-550-10INVEGA10 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1043
50458-550-98INVEGA7 in 1 BOTTLETABLET, EXTENDED RELEASE743

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-550-01EA - Each50458-550dbb7c7fc-f15a-4679-9684-5bae84c458bb12012-07-24
50458-550-10EA - Each50458-5504fa61bde-6b37-4384-a8c0-6259e01b454112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
paliperidoneACTIVE INGREDIENT838F01T721INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
paliperidoneACTIVE MOIETY838F01T721INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
carnauba waxINACTIVE INGREDIENTR12CBM0EIZINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
cellulose acetateINACTIVE INGREDIENT3J2P07GVB6INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
hypromellosesINACTIVE INGREDIENT3NXW29V3WOINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
povidonesINACTIVE INGREDIENTFZ989GH94EINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
propylene glycolINACTIVE INGREDIENT6DC9Q167V3INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
sodium chlorideINACTIVE INGREDIENT451W47IQ8XINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
stearic acidINACTIVE INGREDIENT4ELV7Z65APINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
triacetinINACTIVE INGREDIENTXHX3C3X673INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]17
paliperidoneACTIVE INGREDIENT838F01T721INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
paliperidoneACTIVE MOIETY838F01T721INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2
TRIACETININACTIVE INGREDIENTXHX3C3X673INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-550INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]40Current NDC, Legacy NDC, 4 package rows20250209_7b8e5b26-b9e4-4704-921b-3c3c0d159916.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866105INVEGA 1.5 MG 24HR Extended Release Oral TabletPSN7b8e5b26-b9e4-4704-921b-3c3c0d15991643
686441INVEGA 3 MG 24HR Extended Release Oral TabletPSN7b8e5b26-b9e4-4704-921b-3c3c0d15991643
686443INVEGA 6 MG 24HR Extended Release Oral TabletPSN7b8e5b26-b9e4-4704-921b-3c3c0d15991643
686445INVEGA 9 MG 24HR Extended Release Oral TabletPSN7b8e5b26-b9e4-4704-921b-3c3c0d15991643
866103paliperidone 1.5 MG 24HR Extended Release Oral TabletPSN7b8e5b26-b9e4-4704-921b-3c3c0d15991643
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN7b8e5b26-b9e4-4704-921b-3c3c0d15991643
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN7b8e5b26-b9e4-4704-921b-3c3c0d15991643
672571paliperidone 9 MG 24HR Extended Release Oral TabletPSN7b8e5b26-b9e4-4704-921b-3c3c0d15991643
86610524 HR paliperidone 1.5 MG Extended Release Oral Tablet [Invega]SBD7b8e5b26-b9e4-4704-921b-3c3c0d15991643
68644124 HR paliperidone 3 MG Extended Release Oral Tablet [Invega]SBD7b8e5b26-b9e4-4704-921b-3c3c0d15991643
68644324 HR paliperidone 6 MG Extended Release Oral Tablet [Invega]SBD7b8e5b26-b9e4-4704-921b-3c3c0d15991643
68644524 HR paliperidone 9 MG Extended Release Oral Tablet [Invega]SBD7b8e5b26-b9e4-4704-921b-3c3c0d15991643
86610324 HR paliperidone 1.5 MG Extended Release Oral TabletSCD7b8e5b26-b9e4-4704-921b-3c3c0d15991643
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD7b8e5b26-b9e4-4704-921b-3c3c0d15991643
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD7b8e5b26-b9e4-4704-921b-3c3c0d15991643
67257124 HR paliperidone 9 MG Extended Release Oral TabletSCD7b8e5b26-b9e4-4704-921b-3c3c0d15991643
68644124 HR Invega 3 MG Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
68644324 HR Invega 6 MG Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
68644524 HR Invega 9 MG Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
866105Invega 1.5 MG 24 HR Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
686441Invega 3 MG 24 HR Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
686443Invega 6 MG 24 HR Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
686445Invega 9 MG 24 HR Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
866103paliperidone 1.5 MG 24 HR Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
672571paliperidone 9 MG 24 HR Extended Release Oral TabletSY7b8e5b26-b9e4-4704-921b-3c3c0d15991643
686441INVEGA 3 MG 24HR Extended Release Oral TabletPSN87d7eb59-2177-431d-bf6b-e14509c0c8292
672567paliperidone 3 MG 24HR Extended Release Oral TabletPSN87d7eb59-2177-431d-bf6b-e14509c0c8292
68644124 HR paliperidone 3 MG Extended Release Oral Tablet [Invega]SBD87d7eb59-2177-431d-bf6b-e14509c0c8292
67256724 HR paliperidone 3 MG Extended Release Oral TabletSCD87d7eb59-2177-431d-bf6b-e14509c0c8292
68644124 HR Invega 3 MG Extended Release Oral TabletSY87d7eb59-2177-431d-bf6b-e14509c0c8292
686441Invega 3 MG 24 HR Extended Release Oral TabletSY87d7eb59-2177-431d-bf6b-e14509c0c8292
672567paliperidone 3 MG 24 HR Extended Release Oral TabletSY87d7eb59-2177-431d-bf6b-e14509c0c8292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50458-550-015045805500130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01) 2006-12-190000-00-00NoNoCurrent
50458-550-105045805501010 in 1 BLISTER PACKHistorical
50458-550-98504580550987 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-98) 2006-12-190000-00-00NoNoCurrent