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
NDC Product Code0185-0448
Application NumberANDA040445
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 27, 2022
Generic NameMetaxalone
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