Metaxalone by Central Packaging / Central Packaging, LLC METAXALONE tablet

Metaxalone by

Drug Labeling and Warnings

Metaxalone by is a Prescription medication manufactured, distributed, or labeled by Central Packaging, Central Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

METAXALONE 
metaxalone tablet

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

Labeler - Central Packaging (117617671)

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