Metaxalone
Metaxalone Tablets 800 mg
Approved
Approval ID
9b22176d-95af-46d6-b02b-6a45ccb115ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metaxalone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-4668
Application NumberNDA013217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification
INGREDIENTS (5)
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM ALGINATEInactive
Code: 8P20S56HZI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT