Doxorubicin Hydrochloride Injectable, Liposomal
FDA Label NDC 49315-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Doxorubicin Hydrochloride (NDC 49315-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 (Ad13df03 7d20 4ea9 Aaf2 0358a5e0ced3 01)

20 mg/10ml Vial Label (Ad13df03 7d20 4ea9 Aaf2 0358a5e0ced3 01)

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

20 mg/10 mL Carton Label (Ad13df03 7d20 4ea9 Aaf2 0358a5e0ced3 02)

20 mg/10 mL Carton Label (Ad13df03 7d20 4ea9 Aaf2 0358a5e0ced3 02)

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 (Ad13df03 7d20 4ea9 Aaf2 0358a5e0ced3 03)

50 mg/25ml Vial Label (Ad13df03 7d20 4ea9 Aaf2 0358a5e0ced3 03)

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

50 mg/25 mL Carton Label (Ad13df03 7d20 4ea9 Aaf2 0358a5e0ced3 04)

50 mg/25 mL Carton Label (Ad13df03 7d20 4ea9 Aaf2 0358a5e0ced3 04)

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