Metaxalone
These highlights do not include all the information needed to use METAXALONE TABLETS, 640 mg, safely and effectively. See full prescribing information for METAXALONE TABLETS, 640 mg. METAXALONE tablets, for oral useInitial U.S. Approval: 1962
Approved
Approval ID
f27ca677-f0cc-4710-bd94-ff1bf0d916cb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Primus Pharmaceuticals
DUNS: 130834745
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 Code68040-712
Application NumberNDA022503
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (7)
METAXALONEActive
Quantity: 640 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT