NDC Code(s) : 55154-3650-1, 55154-3650-6, 55154-3650-4, 55154-3650-0
Packager : Cardinal Health

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:55154-3650(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)
CALCIUM ALGINATE(UNII: 8P20S56HZI)
CARMINIC ACID(UNII: CID8Z8N95N)
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:55154-3650-1100 in 1 BOTTLE
2NDC:55154-3650-4100 in 1 CARTON
2NDC:55154-3650-61 in 1 POUCH
3NDC:55154-3650-010 in 1 BAG
31 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA013217 08/30/2002

PRINCIPAL DISPLAY PANEL

Skelaxin®

(metaxalone)

800 mg

100 Tablets

Skelaxin Label

PRINCIPAL DISPLAY PANEL

Skelaxin®

(metaxalone)

800 mg

100 Tablets

Label

PRINCIPAL DISPLAY PANEL

Skelaxin®

(metaxalone)

800 mg

Tablet

Pouch

PRINCIPAL DISPLAY PANEL

Skelaxin®

(metaxalone)

800 mg

10 Tablets

Bag Label