ROCURONIUM BROMIDE
ROCURONIUM BROMIDE INJ. 100mg/10mL (10mg/mL) 10mL VIAL
Approved
Approval ID
818f7cc6-2c3f-1788-e053-2991aa0a4c6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2021
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
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 Code51662-1355
Application NumberANDA078519
Product Classification
M
Marketing Category
C73584
G
Generic Name
ROCURONIUM BROMIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 1, 2021
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 3.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ROCURONIUM BROMIDEActive
Quantity: 10 mg in 1 mL
Code: I65MW4OFHZ
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT