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
a0a058f9-1618-4853-9b8a-e9768ee86b39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code70710-1208
Application NumberANDA208980
Product Classification
M
Marketing Category
C73584
G
Generic Name
plerixafor
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 3, 2023
FDA Product Classification
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