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
f26effc5-2a22-441f-91ac-e131ee1c9886
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2023
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
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 Code72205-249
Application NumberANDA211901
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateMay 31, 2023
Generic NamePlerixafor
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
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
WATERInactive
Code: 059QF0KO0R
Classification: IACT