NDC Code(s) : 69189-0551-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

INVEGApaliperidone TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0551(NDC:50458-551)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
paliperidone(UNII: 838F01T721)
(paliperidone - UNII:838F01T721) 		paliperidone6 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax(UNII: R12CBM0EIZ)
cellulose acetate(UNII: 3J2P07GVB6)
polyethylene glycols(UNII: 3WJQ0SDW1A)
propylene glycol(UNII: 6DC9Q167V3)
povidones(UNII: FZ989GH94E)
sodium chloride(UNII: 451W47IQ8X)
stearic acid(UNII: 4ELV7Z65AP)
butylated hydroxytoluene(UNII: 1P9D0Z171K)
hypromelloses(UNII: 3NXW29V3WO)
titanium dioxide(UNII: 15FIX9V2JP)
ferrosoferric oxide(UNII: XM0M87F357)
Product Characteristics
Color BROWN (beige) Score no score
Shape OVAL (capsule shaped) Size 11 mm
Flavor Imprint Code PAL;6
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0551-11 in 1 DOSE PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021999 05/29/2015

PRINCIPAL DISPLAY PANEL

Paliperidone ER 6 mg tablet label