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 useInitial U.S. Approval: 1995
Approved
Approval ID
1be30efe-4beb-411a-bf82-6e4ea68fd262
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 5, 2023
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-714
Application NumberANDA211669
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (3)
CISATRACURIUM BESYLATEActive
Quantity: 20 mg in 10 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
Cisatracurium Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-713
Application NumberANDA211668
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (2)
CISATRACURIUM BESYLATEActive
Quantity: 200 mg in 20 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
Cisatracurium Besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-712
Application NumberANDA211668
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisatracurium Besylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (2)
CISATRACURIUM BESYLATEActive
Quantity: 10 mg in 5 mL
Code: 80YS8O1MBS
Classification: ACTIM
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT