DOXOrubicin Hydrochloride Liposome Injection

Label at a glance#

Label contents#

Full prescribing information#

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/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 2⁰ to 8℃ (36⁰ to 46℉)

Do not freeze

10 mL Single-Dose Vial

Rx only

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/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 2⁰ to 8℃ (36⁰ to 46℉)

Do not freeze

25 mL Single-Dose Vial

Rx only

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

• DOXORUBICIN HYDROCHLORIDE
• DOXORUBICIN
• N-(CARBONYL-METHOXYPOLYETHYLENE GLYCOL 2000)-1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, SODIUM SALT
• HYDROGENATED SOYBEAN LECITHIN
• CHOLESTEROL
• AMMONIUM SULFATE
• SUCROSE
• HISTIDINE
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 80 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.