Metaxalone

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

American Health Packaging

DUNS Number

929561009

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

60687-663

Application Number

ANDA207466

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 3, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ALGINIC ACIDInactive

Code: 8C3Z4148WZClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8BClass: IACT

SODIUM ALGINATEInactive

Code: C269C4G2ZQClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Code: 1NMA9J598YClass: ACTIBQuantity: 800 mg in 1 1