Raxibacumab
These highlights do not include all the information needed to use RAXIBACUMAB safely and effectively. See full prescribing information for RAXIBACUMAB. RAXIBACUMAB injection, for intravenous useInitial U.S. Approval: 2012
Approved
Approval ID
f6927e91-bb46-47b3-ab66-f9d8a9d7b12a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2021
Manufacturers
FDA
Emergent Manufacturing Operations Baltimore LLC
DUNS: 968316831
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
raxibacumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71655-103
Application NumberBLA125349
Product Classification
M
Marketing Category
C73585
G
Generic Name
raxibacumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 14, 2021
FDA Product Classification
INGREDIENTS (6)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
RAXIBACUMABActive
Quantity: 50 mg in 1 mL
Code: 794PGL549S
Classification: ACTIB
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT