INVEGA

Product NDC
21695-455
11-digit product format
216950455
Labeler code
21695
Product ID
21695-455_8de6a6eb-9ed8-4e05-9a4c-d657b5634f76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paliperidone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021999
Marketing category
NDA
Marketing start
2006-12-19
Marketing end
0000-00-00
Substance
PALIPERIDONE
Active strength
6 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-455-30INVEGA30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-455-30EA - Each21695-455462923c2-bafb-4a57-95f1-2abcd7be7c0712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
paliperidoneACTIVE INGREDIENT838F01T721INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
paliperidoneACTIVE MOIETY838F01T721INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
cellulose acetateINACTIVE INGREDIENT3J2P07GVB6INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
povidoneINACTIVE INGREDIENTFZ989GH94EINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPINVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-455INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110104_8de6a6eb-9ed8-4e05-9a4c-d657b5634f76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686443INVEGA 6 MG 24HR Extended Release Oral TabletPSN8de6a6eb-9ed8-4e05-9a4c-d657b5634f761
672569paliperidone 6 MG 24HR Extended Release Oral TabletPSN8de6a6eb-9ed8-4e05-9a4c-d657b5634f761
68644324 HR paliperidone 6 MG Extended Release Oral Tablet [Invega]SBD8de6a6eb-9ed8-4e05-9a4c-d657b5634f761
67256924 HR paliperidone 6 MG Extended Release Oral TabletSCD8de6a6eb-9ed8-4e05-9a4c-d657b5634f761
68644324 HR Invega 6 MG Extended Release Oral TabletSY8de6a6eb-9ed8-4e05-9a4c-d657b5634f761
686443Invega 6 MG 24 HR Extended Release Oral TabletSY8de6a6eb-9ed8-4e05-9a4c-d657b5634f761
672569paliperidone 6 MG 24 HR Extended Release Oral TabletSY8de6a6eb-9ed8-4e05-9a4c-d657b5634f761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-455-302169504553030 in 1 BOTTLEHistorical