Metaxalone
Metaxalone Tablets, USP
Approved
Approval ID
0aff6dda-b9fd-4f01-85b2-eb3097b760b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 27, 2022
Manufacturers
FDA
Eon Labs, Inc.
DUNS: 012656273
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 Code0185-0448
Application NumberANDA040445
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2022
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
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT