Skelaxin
SKELAXIN (Metaxalone) Tablets
Approved
Approval ID
cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-123
Application NumberNDA013217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateJune 12, 2007
FDA Product Classification
INGREDIENTS (1)
MetaxaloneActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB