Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Quality Care Products, LLC
Quality Care Products, LLC
831276758
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
55700-911Application Number
ANDA203695Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 18, 2022MetaxaloneActive
Code: 1NMA9J598YClass: ACTIBQuantity: 800 mg in 1 1
ALGINIC ACIDInactive
Code: 8C3Z4148WZClass: IACT
AMMONIUM ALGINATEInactive
Code: Q9QKJ39Q3XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CALCIUM ALGINATEInactive
Code: 8P20S56HZIClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT