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
93101770-10a1-4bad-a762-289c793d8ace
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2023
Manufacturers
FDA
Caplin Steriles Limited
DUNS: 650744670
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 Code65145-137
Application NumberANDA217725
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (4)
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
CISATRACURIUM BESYLATEActive
Quantity: 10 mg in 1 mL
Code: 80YS8O1MBS
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
Cisatracurium besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-136
Application NumberANDA217725
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (5)
NITROGENInactive
Code: N762921K75
Classification: IACT
CISATRACURIUM BESYLATEActive
Quantity: 2 mg in 1 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Cisatracurium besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-135
Application NumberANDA217725
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (4)
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
CISATRACURIUM BESYLATEActive
Quantity: 2 mg in 1 mL
Code: 80YS8O1MBS
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT