NDC Code(s) : 10094-350-60
Packager : Aquestive Therapeutics

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EXSERVANriluzole FILM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10094-350
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RILUZOLE(UNII: 7LJ087RS6F)
(RILUZOLE - UNII:7LJ087RS6F) 		RILUZOLE50 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 900000(UNII: 16P9295IIL)
PULLULAN(UNII: 8ZQ0AYU1TT)
POLACRILIN(UNII: RCZ785HI7S)
POLYETHYLENE OXIDE 100000(UNII: V46Y6OJ5QB)
CHONDRUS CRISPUS CARRAGEENAN (30% SULFATE)(UNII: UG384JHM3E)
HYPROMELLOSES(UNII: 3NXW29V3WO)
XANTHAN GUM(UNII: TTV12P4NEE)
SUCRALOSE(UNII: 96K6UQ3ZD4)
XYLITOL(UNII: VCQ006KQ1E)
FRUCTOSE(UNII: 6YSS42VSEV)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOOLEATE(UNII: C4YAD5F5G6)
Product Characteristics
Color ORANGE Score
Shape RECTANGLE Size
Flavor Imprint Code R50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10094-350-6050 in 1 CARTON 24/01/2019
11 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212640 01/24/2019

LABELER - Aquestive Therapeutics(615102303)

PRINCIPAL DISPLAY PANEL

NDC 10094-350-01
Exservan
(riluzole) oral film
50 mg
Rx Only
1 Oral Film

NDC 10094-350-01 Exservan (riluzole) oral film 50 mg Rx Only 1 Oral Film

PRINCIPAL DISPLAY PANEL

NDC 10094-350-60
Exservan
(riluzole) oral film
50 mg
Rx Only
60 Pouches each containing
1 Oral Film

NDC 10094-350-60 Exservan (riluzole) oral film 50 mg Rx Only 60 Pouches each containing 1 Oral Film