Metaxalone
Metaxalone Tablets, USP Repackaged RX Only
Approved
Approval ID
55ee8760-c602-5240-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2018
Manufacturers
FDA
California Pharmaceuticals, LLC
DUNS: 021420944
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 Code70332-330
Application NumberANDA204770
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2018
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT