Rocuronium
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
98255b70-51f9-8d16-e053-2995a90a8f97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Piramal Critical Care Inc
DUNS: 805600439
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rocuronium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66794-228
Application NumberANDA210437
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rocuronium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ROCURONIUM BROMIDEActive
Quantity: 50 mg in 5 mL
Code: I65MW4OFHZ
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Rocuronium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66794-229
Application NumberANDA210437
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rocuronium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ROCURONIUM BROMIDEActive
Quantity: 100 mg in 10 mL
Code: I65MW4OFHZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT