Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metaxalone
Product Details
NDC Product Code
63629-8014Application Number
ANDA203695Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 12, 2020STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZClass: IACT
AMMONIUM ALGINATEInactive
Code: Q9QKJ39Q3XClass: IACT
MetaxaloneActive
Code: 1NMA9J598YClass: ACTIBQuantity: 800 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CALCIUM ALGINATEInactive
Code: 8P20S56HZIClass: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
SPL UNCLASSIFIED SECTION
Rx Only