FDA Label for Doxorubicin Hydrochloride
View Indications, Usage & Precautions
Doxorubicin Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Zydus Lifesciences Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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