Metaxalone
Metaxalone 800mg Tablets
Approved
Approval ID
b713a0f2-d47a-0ae7-e053-2995a90a5b85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2023
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
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 Code80425-0122
Application NumberANDA204770
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2023
FDA Product Classification
INGREDIENTS (1)
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB