Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc.
946499746
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ROBAXIN
Product Details
NDC Product Code
0641-6103Application Number
NDA011790Marketing Category
NDA (C73594)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
January 18, 2024HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
MethocarbamolActive
Code: 125OD7737XClass: ACTIBQuantity: 100 mg in 1 mL
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQClass: IACTQuantity: 0.5 mL in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT