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, for intravenous use Initial U.S. Approval: 1994
Approved
Approval ID
c96726ef-f1fa-4ebb-ba33-3479c3902a8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 6, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-7037
Application NumberANDA205656
Product Classification
M
Marketing Category
C73584
G
Generic Name
rocuronium bromide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ROCURONIUM BROMIDEActive
Quantity: 10 mg in 1 mL
Code: I65MW4OFHZ
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 3.10 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
rocuronium bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-3189
Application NumberANDA205656
Product Classification
M
Marketing Category
C73584
G
Generic Name
rocuronium bromide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (5)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
ROCURONIUM BROMIDEActive
Quantity: 10 mg in 1 mL
Code: I65MW4OFHZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 3.10 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT