Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
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
54868-6102Application Number
ANDA040445Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 17, 2011MetaxaloneActive
Code: 1NMA9J598YClass: ACTIBQuantity: 800 mg in 1 1
ACACIAInactive
Code: 5C5403N26OClass: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT