NDC Code(s) : 49349-945-10
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Metaxalone Metaxalone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-945(NDC:64720-321)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METAXALONE(UNII: 1NMA9J598Y)
(METAXALONE - UNII:1NMA9J598Y) 		METAXALONE800 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID(UNII: 8C3Z4148WZ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
CALCIUM ALGINATE(UNII: 8P20S56HZI)
Product Characteristics
Color pink Score 2 pieces
Shape OVAL (TABLET) Size 19 mm
Flavor Imprint Code M;5859
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-945-106 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA013217 03/29/2012

PRINCIPAL DISPLAY PANEL

DRUG: Metaxalone
GENERIC: Metaxalone
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-945-10
STRENGTH:800 mg
COLOR: pink
SHAPE: OVAL
SCORE: Two even pieces
SIZE: 19 mm
IMPRINT: 6
QTY: 6

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