NDC Code(s) : 49999-363-15, 49999-363-20, 49999-363-30, 49999-363-60, 49999-363-90
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SKELAXINmetaxalone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-363(NDC:60793-136)
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)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color pink Score 2 pieces
Shape OVAL Size 20 mm
Flavor Imprint Code 8667;S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49999-363-1515 in 1 BOTTLE Type 0: Not a Combination Product14/12/2011
2NDC:49999-363-2020 in 1 BOTTLE Type 0: Not a Combination Product14/12/2011
3NDC:49999-363-3030 in 1 BOTTLE Type 0: Not a Combination Product14/12/2011
4NDC:49999-363-6060 in 1 BOTTLE Type 0: Not a Combination Product14/12/2011
5NDC:49999-363-9090 in 1 BOTTLE Type 0: Not a Combination Product14/12/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA013217 12/14/2011

PRINCIPAL DISPLAY PANEL

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