Metaxalone
Metaxalone T ablets , USP
Approved
Approval ID
07ccff59-e335-40be-9e40-fd2d08197617
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2020
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-8014
Application NumberANDA203695
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2020
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
AMMONIUM ALGINATEInactive
Code: Q9QKJ39Q3X
Classification: IACT
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM ALGINATEInactive
Code: 8P20S56HZI
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 5/11/2020
Rx Only