Plerixafor
These highlights do not include all the information needed to use PLERIXAFOR safely and effectively. See full prescribing information for PLERIXAFOR. PLERIXAFOR injection, for subcutaneous use Initial U.S. Approval: 2008
Approved
Approval ID
5d670cb4-163e-498c-b5fa-c193ea9d55c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2023
Manufacturers
FDA
Fresenius Kabi Usa, LLC
DUNS: 013547657
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PLERIXAFOR
PRODUCT DETAILS
NDC Product Code65219-284
Application NumberNDA022311
Marketing CategoryC73605
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 30, 2023
Generic NamePLERIXAFOR
INGREDIENTS (5)
PLERIXAFORActive
Quantity: 24 mg in 1.2 mL
Code: S915P5499N
Classification: ACTIB
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