Atracurium Besylate
ATRACURIUM BESYLATE INJECTION USP
Approved
Approval ID
de1c2dcd-295b-47ce-b7a1-a8be59939a54
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 23, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ATRACURIUM BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1109
Application NumberANDA090782
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATRACURIUM BESYLATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2022
FDA Product Classification
INGREDIENTS (2)
ATRACURIUM BESYLATEActive
Quantity: 10 mg in 1 mL
Code: 40AX66P76P
Classification: ACTIB
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT
ATRACURIUM BESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1105
Application NumberANDA090761
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATRACURIUM BESYLATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2022
FDA Product Classification
INGREDIENTS (3)
ATRACURIUM BESYLATEActive
Quantity: 10 mg in 1 mL
Code: 40AX66P76P
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
BENZENESULFONIC ACIDInactive
Code: 685928Z18A
Classification: IACT