FDA.reportPublic FDA data

INVEGA

Product NDC
50458-554
11-digit product format
504580554
Labeler code
50458
Product ID
50458-554_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
2009-09-10
Substance
PALIPERIDONE
Active strength
1.5 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
PALIPERIDONE1.5 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
50458-554-01INVEGA30 in 1 BOTTLETABLET, EXTENDED RELEASE3043
50458-554-10INVEGA10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1043
50458-554-10INVEGA10 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1043
50458-554-98INVEGA7 in 1 BOTTLETABLET, EXTENDED RELEASE743

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-554-01EA - Each50458-554cf14bcab-d3d8-4cfb-9126-8fc2743acae312012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-554INVEGA (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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-554-015045805540130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-554-01) 2009-09-100000-00-00NoNoCurrent
50458-554-105045805541010 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-554-10) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2009-09-100000-00-00NoNoCurrent
50458-554-98504580554987 in 1 BOTTLEHistorical