Mozobil
These highlights do not include all the information needed to use MOZOBIL safely and effectively. See full prescribing information for MOZOBIL. MOZOBIL (plerixafor) injection, for subcutaneous use Initial U.S. Approval: 2008
Approved
Approval ID
0ed08d2b-5051-46b2-aa37-1d6275bf9003
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
sanofi-aventis U.S. LLC
DUNS: 824676584
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PLERIXAFOR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0024-5862
Application NumberNDA022311
Product Classification
M
Marketing Category
C73594
G
Generic Name
PLERIXAFOR
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 5.9 mg in 1.2 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PLERIXAFORActive
Quantity: 24 mg in 1.2 mL
Code: S915P5499N
Classification: ACTIB