Plerixafor
These highlights do not include all the information needed to use PLERIXAFOR INJECTION safely and effectively. See full prescribing information for PLERIXAFOR INJECTION. PLERIXAFOR injection, for subcutaneous use Initial U.S. Approval: 2008
Approved
Approval ID
30e0d15f-46dd-4a25-9936-34db421e4076
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
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 Code55150-356
Application NumberANDA213672
Product Classification
M
Marketing Category
C73584
G
Generic Name
Plerixafor
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 2, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PLERIXAFORActive
Quantity: 24 mg in 1.2 mL
Code: S915P5499N
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT