Label: DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL- doxorubicin hydrochloride injection, suspension, liposomal

  • NDC Code(s): 0338-9581-01, 0338-9581-02
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

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Drug Label Information

Updated December 19, 2023

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  • HEALTH CARE PROVIDER LETTER

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 20 mg/10 mL

    10ml-container-label

    Caelyx® pegylated liposomal
    2 mg/ml
    sterile concentrate

    doxorubicin hydrochloride

    20 mg/10 mL

    IV after dilution.

    10ml-carton-label

    Caelyx®

    pegylated liposomal

    2 mg/ml

    concentrate for

    solution for infusion

    doxorubicin hydrochloride

    20 mg/10 mL

    Intravenous use after

    dilution.

    Do not use interchangeably
    with other formulations of
    doxorubicin hydrochloride.

    Cytotoxic

    1 vial

    Baxter Logo

    One ml of Caelyx pegylated
    liposomal contains 2 mg
    doxorubicin hydrochloride.

    Excipients: α-(2-[1,2-distearoyl-sn-glycero(3)
    phosphooxy]ethylcarbamoyl)
    -ϖ-methoxypoly(oxyethylen)-40
    sodium salt, fully hydrogenated
    soy phosphatidylcholine,
    cholesterol, ammonium
    sulphate, sucrose, histidine,
    water for injections,
    hydrochloric acid and sodium
    hydroxide.

    Keep out of the sight and
    reach of children.

    Store in a refrigerator.
    Do not freeze.

    Read the package leaflet
    before use.

    Baxter Healthcare Limited

    Caxton Way,

    Thetford,

    Norfolk,

    IP24 3SE,

    United Kingdom

    PLGB 00116/0255

  • INGREDIENTS AND APPEARANCE
    DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL 
    doxorubicin hydrochloride injection, suspension, liposomal
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9581
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    doxorubicin hydrochloride (UNII: 82F2G7BL4E) (doxorubicin - UNII:80168379AG) doxorubicin hydrochloride2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE (UNII: 3L6NN8ZZKU) 3.19 mg  in 1 mL
    hydrogenated soybean lecithin (UNII: H1109Z9J4N) 9.58 mg  in 1 mL
    cholesterol (UNII: 97C5T2UQ7J) 3.19 mg  in 1 mL
    ammonium sulfate (UNII: SU46BAM238) 0.6 mg  in 1 mL
    histidine (UNII: 4QD397987E) 1.55 mg  in 1 mL
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sucrose (UNII: C151H8M554) 94 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9581-021 in 1 CARTON12/19/2023
    1NDC:0338-9581-0110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage12/19/2023
    Labeler - Baxter Healthcare Corporation (005083209)
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