LUMOXITI
These highlights do not include all the information needed to use LUMOXITI safely and effectively. See full prescribing information for LUMOXITI.LUMOXITI (moxetumomab pasudotox-tdfk) for injection, for intravenous useInitial U.S. Approval: 2018
Approved
Approval ID
d6510282-1a57-4614-9859-299a227a089c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2022
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
moxetumomab pasudotox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-4700
Application NumberBLA761104
Product Classification
M
Marketing Category
C73585
G
Generic Name
moxetumomab pasudotox
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 8, 2022
FDA Product Classification
INGREDIENTS (5)
MOXETUMOMAB PASUDOTOXActive
Quantity: 1 mg in 1 mL
Code: 2NDX4B6N8F
Classification: ACTIB
GLYCINEInactive
Quantity: 80 mg in 1 mL
Code: TE7660XO1C
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.2 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Quantity: 40 mg in 1 mL
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 3.4 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
IV Solution Stabilizer
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-4715
Application NumberBLA761104
Product Classification
M
Marketing Category
C73585
G
Generic Name
IV Solution Stabilizer
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 8, 2022
FDA Product Classification
INGREDIENTS (4)
POLYSORBATE 80Active
Quantity: 6.5 mg in 1 mL
Code: 6OZP39ZG8H
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.7 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 6.4 mg in 1 mL
Code: B22547B95K
Classification: IACT
WATERInactive
Quantity: 1.0 mg in 1 mL
Code: 059QF0KO0R
Classification: IACT