Cisatracurium Besylate
These highlights do not include all the information needed to use CISATRACURIUM BESYLATE INJECTION safely and effectively. See full prescribing information for CISATRACURIUM BESYLATE INJECTION. CISATRACURIUM BESYLATE injection, for intravenous use Initial U.S. Approval: 1995
Approved
Approval ID
2cb05c7e-6228-4e2d-a270-7659e3db3fa7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cisatracurium Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-284
Application NumberANDA209665
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (3)
CISATRACURIUM BESYLATEActive
Quantity: 10 mg in 5 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Cisatracurium Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-286
Application NumberANDA209144
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (4)
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CISATRACURIUM BESYLATEActive
Quantity: 20 mg in 10 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT