ROBAXIN
ROBAXIN Injectable (methocarbamol injection, USP)
Approved
Approval ID
090a3d3d-92c3-4c30-a648-436461f81702
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methocarbamol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6103
Application NumberNDA011790
Product Classification
M
Marketing Category
C73594
G
Generic Name
methocarbamol
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHOCARBAMOLActive
Quantity: 100 mg in 1 mL
Code: 125OD7737X
Classification: ACTIB
POLYETHYLENE GLYCOL 300Inactive
Quantity: 0.5 mL in 1 mL
Code: 5655G9Y8AQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT