Metaxalone
Approved
Approval ID
5a0f574e-df84-4682-83eb-87272a7f5294
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2014
Manufacturers
FDA
Northwind Pharmaceuticals
DUNS: 036986393
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 Code51655-162
Application NumberANDA203399
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateJune 17, 2014
FDA Product Classification
INGREDIENTS (1)
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB