ROCURONIUM BROMIDE
These highlights do not include all the information needed to use ROCURONIUM BROMIDE INJECTION safely and effectively. See full prescribing information for ROCURONIUM BROMIDE INJECTION. ROCURONIUM BROMIDE injection, solution for intravenous use Initial U.S. Approval: 1994
Approved
Approval ID
f1794318-b058-4254-97b7-d4e07126efbb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 7, 2023
Manufacturers
FDA
Caplin Steriles Limited
DUNS: 650744670
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ROCURONIUM BROMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-130
Application NumberANDA216234
Product Classification
M
Marketing Category
C73584
G
Generic Name
ROCURONIUM BROMIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (5)
ROCURONIUM BROMIDEActive
Quantity: 10 mg in 1 mL
Code: I65MW4OFHZ
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ROCURONIUM BROMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-131
Application NumberANDA216234
Product Classification
M
Marketing Category
C73584
G
Generic Name
ROCURONIUM BROMIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (5)
ROCURONIUM BROMIDEActive
Quantity: 10 mg in 1 mL
Code: I65MW4OFHZ
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT