Metaxalone
Metaxalone Tablets, USP (800 mg) Rx Only
Approved
Approval ID
f06f2b96-3684-483c-89f7-6c9201fd4664
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
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 Code53746-553
Application NumberANDA203399
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2023
FDA Product Classification
INGREDIENTS (10)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT