Metaxalone tablet

Ingredients and appearance - Product information

Metaxalone tablet- Metaxalone

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60760-093
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Metaxalone ( UNII: 1NMA9J598Y)( Metaxalone - UNII: 1NMA9J598Y ) 800 mgin 1

Inactive Ingredients

Ingredient Name Code
Alginic acid ( UNII: 8C3Z4148WZ)
Ammonium alginate ( UNII: Q9QKJ39Q3X)
Calcium alginate ( UNII: 8P20S56HZI)
Starch, corn ( UNII: O8232NY3SJ)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color white (white to off-white) Imprint Code 31;90;WPI
Score 2 Shape OVAL (capsule-shaped)
Size 19 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 60760-093-20 20 in 1 BOTTLE, PLASTIC 2017/11/10
2 NDC: 60760-093-30 30 in 1 BOTTLE, PLASTIC 2017/11/10
3 NDC: 60760-093-90 90 in 1 BOTTLE, PLASTIC 2017/11/10
4 NDC: 60760-093-06 6 in 1 BOTTLE, PLASTIC 2018/04/24
5 NDC: 60760-093-60 60 in 1 BOTTLE, PLASTIC 2018/06/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA203695 USA 2018/06/28

Labeler - St. Mary's Medical Park Pharmacy( 063050751)

Establishment

Name ID/FEI Business Operations
St. Mary's Medical Park Pharmacy 063050751 relabel( 60760-093), repack( 60760-093)