Metaxalone
Metaxalone Tablets, 800 mg
Approved
Approval ID
c3ad15a2-c518-45f3-a322-9ddcfe4bae77
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6102
Application NumberANDA040445
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2011
FDA Product Classification
INGREDIENTS (7)
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT