FDA.reportPublic FDA data

INVEGA

Product NDC
64725-0550
11-digit product format
647250550
Labeler code
64725
Product ID
64725-0550_67e10f52-3747-4542-bb6e-1afccd2df3fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paliperidone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
NDA021999
Marketing category
NDA
Marketing start
2006-12-19
Marketing end
0000-00-00
Substance
PALIPERIDONE
Active strength
3 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0550-12019-11-27C16284748780-19855e2a2-4848-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use INVEGA safely and effectively. See full prescribing information for INVEGA . INVEGA (paliperidone) Extended-Release Tablets Initial U.S. Approval: 2006 ® ® ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0550-1INVEGA30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
64725-0550INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140926_87d7eb59-2177-431d-bf6b-e14509c0c829.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
64725-0550-16472505500130 in 1 BOTTLEHistorical