Label: DOXORUBICIN HYDROCHLORIDE injectable, liposomal

  • NDC Code(s): 49315-008-03, 49315-009-07
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 15, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    20 mg/10 mL Container Label

    NDC 49315-008-03

    DOXOrubicin Hydrochloride Liposome Injection

    20 mg/10 mL

    (2 mg/mL)

    Cytotoxic Agent                           Must be diluted

    LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL

    FOR INTRAVENOUS INFUSION ONLY

    10 mL Single-Dose Vial

    Rx only

    20 mg/10mL vial label

    20 mg/10 mL Carton Label

    NDC 49315-008-03

    DOXOrubicin Hydrochloride Liposome Injection

    20 mg/10 mL

    (2 mg/mL)

    Cytotoxic Agent                           Must be diluted

    LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL

    FOR INTRAVENOUS INFUSION ONLY

    Sterile

    Refrigerate at 2? to 8? (36? to 46?)

    Do not freeze

    10 mL Single-Dose Vial

    Rx only

    20 mg/10 mL carton label

    50 mg/25 mL Container Label

    NDC 49315-009-07

    DOXOrubicin Hydrochloride Liposome Injection

    50 mg/25 mL

    (2 mg/mL)

    Cytotoxic Agent                           Must be diluted

    LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL

    FOR INTRAVENOUS INFUSION ONLY

    25 mL Single-Dose Vial

    Rx only

    50 mg/25mL vial label

    50 mg/25 mL Carton Label

    NDC 49315-009-07

    DOXOrubicin Hydrochloride Liposome Injection

    50 mg/25 mL

    (2 mg/mL)

    Cytotoxic Agent                           Must be diluted

    LIPOSOMAL FORMULATION – DO NOT SUBSTITUTE FOR DOXORUBICIN HCL

    FOR INTRAVENOUS INFUSION ONLY

    Sterile

    Refrigerate at 2? to 8? (36? to 46?)

    Do not freeze

    25 mL Single-Dose Vial

    Rx only

    50 mg/25 mL carton label
  • INGREDIENTS AND APPEARANCE
    DOXORUBICIN HYDROCHLORIDE 
    doxorubicin hydrochloride injectable, liposomal
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49315-008
    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
    N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT (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
    SUCROSE (UNII: C151H8M554)  
    HISTIDINE (UNII: 4QD397987E)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49315-008-031 in 1 CARTON09/14/2020
    110 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21229909/14/2020
    DOXORUBICIN HYDROCHLORIDE 
    doxorubicin hydrochloride injectable, liposomal
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49315-009
    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
    N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT (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
    SUCROSE (UNII: C151H8M554)  
    HISTIDINE (UNII: 4QD397987E)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49315-009-071 in 1 CARTON09/14/2020
    125 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21229909/14/2020
    Labeler - Cadila Healthcare Limited (650348852)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650348852ANALYSIS(49315-008, 49315-009) , MANUFACTURE(49315-008, 49315-009)