Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
California Pharmaceuticals, LLC
California Pharmaceuticals, LLC
021420944
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metaxalone
Product Details
NDC Product Code
70332-330Application Number
ANDA204770Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 2, 2018SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MetaxaloneActive
Code: 1NMA9J598YClass: ACTIBQuantity: 800 mg in 1 1
ALGINIC ACIDInactive
Code: 8C3Z4148WZClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT