Metaxalone

Manufacturing Establishments1

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

Labeler

RedPharm Drug, Inc.

DUNS Number

828374897

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

NDC Product Code

67296-0993

Application Number

ANDA203399

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 20, 2022

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UIClass: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGKClass: IACT

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