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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65219-284
Application NumberNDA022311
Product Classification
M
Marketing Category
C73605
G
Generic Name
PLERIXAFOR
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 30, 2023
FDA Product Classification
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