Metaxalone
Approved
Approval ID
bc2cec64-f842-532c-e053-2995a90a554d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2021
Manufacturers
FDA
Central Packaging
DUNS: 117617671
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 Code80175-0472
Application NumberANDA208774
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2021
FDA Product Classification
INGREDIENTS (1)
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB