Metaxalone
Metaxalone T ablets , USP
Approved
Approval ID
e5f5749f-281c-45c3-b181-af3ef5571417
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2022
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
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 Code55700-911
Application NumberANDA203695
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 18, 2022
FDA Product Classification
INGREDIENTS (6)
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
AMMONIUM ALGINATEInactive
Code: Q9QKJ39Q3X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM ALGINATEInactive
Code: 8P20S56HZI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT