Rocuronium Bromide
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .ROCURONIUM BROMIDE injection, solution for intravenous useInitial U.S. Approval: 1994
Approved
Approval ID
31e15c3f-aefa-4379-b684-7707744fe40d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2019
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
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 Code43066-007
Application NumberANDA091115
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rocuronium Bromide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 31, 2019
FDA Product Classification
INGREDIENTS (7)
ROCURONIUM BROMIDEActive
Quantity: 50 mg in 5 mL
Code: I65MW4OFHZ
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
Rocuronium Bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43066-013
Application NumberANDA091115
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rocuronium Bromide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 31, 2019
FDA Product Classification
INGREDIENTS (7)
ROCURONIUM BROMIDEActive
Quantity: 100 mg in 10 mL
Code: I65MW4OFHZ
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT