Label: METAXALONE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-163-20 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 64720-321
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 3, 2014
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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
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INGREDIENTS AND APPEARANCE
METAXALONE
metaxalone tabletProduct 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)