NDC Code(s) : 27808-029-01
Packager : Tris Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nexiclon XR Clonidine FOR SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-029
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE(UNII: MN3L5RMN02)
(CLONIDINE - UNII:MN3L5RMN02) 		CLONIDINE0.09 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM POLYSTYRENE SULFONATE(UNII: 1699G8679Z)
POVIDONE(UNII: FZ989GH94E)
VINYL ACETATE(UNII: L9MK238N77)
TRIACETIN(UNII: XHX3C3X673)
WATER(UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color BROWN (light beige to tan) Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27808-029-01118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022499 12/17/2010

PRINCIPAL DISPLAY PANEL

NEXICLON XR ® (Clonidine Extended Release) Oral Suspension

0.09 mg/mL

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