Metaxalone
METAXALONE TABLETS, USP
Approved
Approval ID
168c539d-3637-4a43-a8b6-cd8e82cf6342
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2020
Manufacturers
FDA
Sterling-Knight Pharmaceuticals, LLC
DUNS: 079556942
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 Code69336-130
Application NumberANDA207466
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2020
FDA Product Classification
INGREDIENTS (8)
METAXALONEActive
Quantity: 400 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT