Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals of New York, LLC
Amneal Pharmaceuticals of New York LLC
123797875
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
53746-553Application Number
ANDA203399Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 11, 2023FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGKClass: IACT
MetaxaloneActive
Code: 1NMA9J598YClass: ACTIBQuantity: 800 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT