Metaxalone by Northwind Pharmaceuticals METAXALONE tablet

Metaxalone by

Drug Labeling and Warnings

Metaxalone by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NDC: 51655-163-20

MFG: 64720-321-10

Metaxalone 800mg

20 caplets

Rx only

Lot#:

Exp. date:

Each tablet contains 800 mg of metaxalone

Dosage: See package insert

Store between 59-86 degrees F.

Protect from moisture.

Store in a tight, light-resistant container (See USP).

Keep out of the reach of children.

Mfg. by: CorePharma, LLC Middlesex, NJ 08846

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

WARNINGS AND PRECAUTIONS

INGREDIENTS AND APPEARANCE

METAXALONE 
metaxalone tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-163(NDC: 64720-321)
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	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	M;5859
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-163-20	20 in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA013217	04/01/2014

Labeler - Northwind Pharmaceuticals (036986393)

Registrant - Northwind Pharmaceuticals (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals		036986393	repack(51655-163)