Metaxalone

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 117023142

Effective Date

February 8, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Metaxalone(800 mg in 1 1)

Manufacturing Establishments1

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

Labeler

Advanced Rx Pharmacy of Tennessee, LLC

DUNS Number

117023142

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

NDC Product Code

80425-0122

Application Number

ANDA204770

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 8, 2023

Ingredients

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