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. use Initial U.S. Approval: 1995
Approved
Approval ID
c6e6823b-fa28-4da2-b3f4-9ad0f92782ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Teva Parenteral Medicines, Inc.
DUNS: 794362533
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 Code0703-2045
Application NumberANDA204960
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (3)
CISATRACURIUM BESYLATEActive
Quantity: 200 mg in 20 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 Code0703-2033
Application NumberANDA204960
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 28, 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 Code0703-2056
Application NumberANDA209334
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (4)
CISATRACURIUM BESYLATEActive
Quantity: 20 mg in 10 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT