PLERIXAFOR
PLERIXAFOR injection, for subcutaneous use
Approved
Approval ID
43df348a-d7f2-4f14-8131-c916679a98eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1776
Application NumberANDA208980
Product Classification
M
Marketing Category
C73584
G
Generic Name
plerixafor
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 28, 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