Skelaxin
Approved
Approval ID
d8684144-6c2d-4664-943a-2d3d2b46b1fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2011
Manufacturers
FDA
Preferred Pharmaceuticals, Inc
DUNS: 791119022
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 Code68788-0881
Application NumberNDA013217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2010
FDA Product Classification
INGREDIENTS (5)
CALCIUMInactive
Code: SY7Q814VUP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT