Doxorubicin Hydrochloride Liposome Injection

Doxorubicin Hydrochloride Liposome Injection
SPL v2
SPL
SPL Set ID bad467d4-7e27-4eda-b4d3-854460f0adab
Route
INTRAVENOUS
Published
Effective Date 2020-09-15
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxorubicin (2 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-09-14
Description

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

Medication Information

Description

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

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

Structured Label Content

Package Label.principal Display Panel (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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:37:24.730536 · Updated: 2026-03-14T21:49:59.697322