Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.

Metaxalone - Bottle

METAXALONE
metaxalone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:80175-0472(NDC:64980-472)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METAXALONE (UNII: 1NMA9J598Y) (METAXALONE - UNII:1NMA9J598Y)	METAXALONE	800 mg

Product Characteristics
Color	pink	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	AC127
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80175-0472-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/24/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208774	09/24/2018

Labeler - Central Packaging (117617671)

Name	Address	ID/FEI	Business Operations
Establishment
Central Packaging, LLC		117617671	repack(80175-0472)