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
7073cb55-f766-4092-a10b-c2cb2863a044
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 23, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 3
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 Code0409-7083
Application NumberANDA203238
Product Classification
M
Marketing Category
C73584
G
Generic Name
CISATRACURIUM BESYLATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (4)
CISATRACURIUM BESYLATEActive
Quantity: 2 mg in 1 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
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 Code0409-3670
Application NumberANDA203236
Product Classification
M
Marketing Category
C73584
G
Generic Name
CISATRACURIUM BESYLATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (3)
CISATRACURIUM BESYLATEActive
Quantity: 10 mg in 1 mL
Code: 80YS8O1MBS
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
CISATRACURIUM BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-5547
Application NumberANDA203236
Product Classification
M
Marketing Category
C73584
G
Generic Name
CISATRACURIUM BESYLATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 5, 2022
FDA Product Classification
INGREDIENTS (3)
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
CISATRACURIUM BESYLATEActive
Quantity: 2 mg in 1 mL
Code: 80YS8O1MBS
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT