Label: PLERIXAFOR injection

  • NDC Code(s): 70771-1776-1
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2023

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1776-1

    Plerixafor Injection – 1.2 mL vial label

    24 mg/1.2 mL

    (20 mg/mL)

    For subcutaneous injection only

    For single-dose only

    Rx only

    vial label

    NDC 70771-1776-1

    Carton contains one vial of

    Plerixafor Injection

    24 mg/1.2 mL

    (20 mg/mL)

    For subcutaneous injection only

    See package insert for dosage and administration

    For single-dose only

    Rx only

    carton label
  • INGREDIENTS AND APPEARANCE
    PLERIXAFOR 
    plerixafor injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1776
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PLERIXAFOR (UNII: S915P5499N) (PLERIXAFOR - UNII:S915P5499N) PLERIXAFOR24 mg  in 1.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 5.9 mg  in 1.2 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1776-11 in 1 CARTON07/28/2023
    11.2 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20898007/28/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650348852MANUFACTURE(70771-1776) , ANALYSIS(70771-1776)