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 useInitial U.S. Approval: 2008
Approved
Approval ID
646d87cd-e2e0-49cf-96e6-112701230969
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
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 Code71288-155
Application NumberANDA215698
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 21, 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
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT