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Doxorubicin Hydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Doxorubicin Hydrochloride | 2 mg/mL | 1790115 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anthracycline Topoisomerase Inhibitor [EPC] | EPC | All 11 members |
| Anthracyclines [CS] | CS | All 11 members |
| Topoisomerase Inhibitors [MoA] | MoA | All 22 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 203263-001 | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | INJECTABLE, LIPOSOMAL | DOXORUBICIN HYDROCHLORIDE | Prescription | AB | RS | |
| 203263-002 | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | INJECTABLE, LIPOSOMAL | DOXORUBICIN HYDROCHLORIDE | Prescription | AB | RS |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 47 | Labeling | Approved | August 4, 2026 | Standard |
| Supplement | 38 | Labeling | Approved | April 14, 2025 | Standard |
| Supplement | 27 | Labeling | Approved | June 26, 2020 | Standard |
| Supplement | 14 | Labeling | Approved | November 3, 2017 | Standard |
| Supplement | 5 | Labeling | Approved | August 25, 2015 | Standard |
| Supplement | 3 | Labeling | Approved | December 21, 2014 | Standard |
| Supplement | 1 | Labeling | Approved | December 12, 2014 | Standard |
| Original application | 1 | Approved | February 4, 2013 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260406). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingBOXED WARNING WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS Doxorubicin hydrochloride liposome injection can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of doxorubicin hydrochloride liposome injection and during and after treatment [see Warnings and Precautions ( 5.1 )] . Serious, life-threatening, and fatal infusion-related reactions can occur with doxorubicin hydrochloride liposome injection. Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold doxorubicin hydrochloride liposome injection for infusion-related reactions and resume at a reduced rate. Discontinue doxorubicin hydrochloride liposome injection for serious or life-threatening infusion-related reactions [see Warnings and Precautions ( 5.2 )] . WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS See full prescribing information for complete boxed warning. Doxorubicin hydrochloride liposome injection can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of doxorubicin hydrochloride liposome injection, during treatment and after treatment ( 5.1 ). Serious, life-threatening, and fatal infusion-related reactions can occur with doxorubicin hydrochloride liposome injection. Acute infusion-related reactions occurred in 11% of patients with solid tumors. Withhold doxorubicin hydrochloride liposome injection for infusion-related reactions and resume at a reduced rate. Discontinue doxorubicin hydrochloride liposome injection for serious or life-threatening infusion-related reactions ( 5.2 ).
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Doxorubicin hydrochloride liposome injection is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer After failure of platinum-based chemotherapy ( 1.1 ). • AIDS-related Kaposi’s Sarcoma After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ) . • Multiple Myeloma In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3 ) . 1.1 Ovarian Cancer Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi’s Sarcoma Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. 1.3 Multiple Myeloma Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION Administer doxorubicin hydrochloride liposome injection at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution ( 2). Ovarian cancer: 50 mg/m 2 intravenously every 4 weeks ( 2.2 ) AIDS-related Kaposi’s Sarcoma: 20 mg/m 2 intravenously every 3 weeks ( 2.3 ) Multiple Myeloma: 30 mg/m 2 intravenously on day 4 following bortezomib ( 2.4 ) 2.1 Important Use Information Do not substitute doxorubicin hydrochloride liposome injection for other doxorubicin hydrochloride products. Do not administer as an undiluted suspension or as an intravenous bolus [see Warnings and Precautions ( 5.2 )]. 2.2 Ovarian Cancer The recommended dose of doxorubicin hydrochloride liposome injection is 50 mg/m 2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity. 2.3 AIDS-Related Kaposi’s Sarcoma The recommended dose of doxorubicin hydrochloride liposome injection is 20 mg/m 2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity. 2.4 Multiple Myeloma The recommended dose of doxorubicin hydrochloride liposome injection is 30 mg/m 2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer doxorubicin hydrochloride liposome injection after bortezomib on day 4 of each cycle [see Clinical Studies ( 14.3 )]. 2.5 Dose Modifications for Adverse Reactions Do not increase doxorubicin hydrochloride liposome injection after a dose reduction for toxicity. Table 1: Recommended Dose Modifications for Hand-Foot Syndrome, Stomatitis, or Hematologic Adverse Reactions Toxicity Dose Adjustment Hand-Foot Syndrome (HFS) Grade 1: Mild erythema, swelling, or desquamation not interfering with daily activities • If no previous Grade 3 or 4 HFS: no dose adjustment. • If previous Grade 3 or 4 HFS: delay dose up to 2 weeks, then decrease dose by 25%. Grade 2: Erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter • Delay dosing up to 2 weeks or until resolved to Grade 0-1. Discontinue doxorubicin hydrochloride liposome injection if no resolution after 2 weeks. • If resolved to Grade 0-1 within 2 weeks: o And no previous Grade 3 or 4 HFS: continue treatment at previous dose. o And previous Grade 3 or 4 toxicity: decrease dose by 25%. Grade 3: Blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing • Delay dosing up to 2 weeks or until resolved to Grade 0-1, then decrease dose by 25%. •Discontinue doxorubicin hydrochloride liposome injection if no resolution after 2 weeks. Grade 4: Diffuse or local process causing infectious complications, or a bed ridden state or hospitalization • Delay dosing up to 2 weeks or until resolved to Grade 0-1, then decrease dose by 25%. •Discontinue doxorubicin hydrochloride liposome injection if no resolution after 2 weeks. Stomatitis Grade 1: Painless ulcers, erythema, or mild soreness • If no previous Grade 3 or 4 toxicity: no dose adjustment. • If previous Grade 3 or 4 toxicity: delay up to 2 weeks then decrease dose by 25%. Grade 2: Painful erythema, edema, or ulcers, but can eat • Delay dosing up to 2 weeks or until resolved to Grade 0-1. • Discontinue doxorubicin hydrochloride liposome injection if there is no resolution after 2 weeks. • If resolved to Grade 0-1 within 2 weeks: o And no previous Grade 3 or 4 stomatitis: resume treatment at previous dose. o And previous Grade 3 or 4 toxicity: decrease dose by 25%. Grade 3: Painful erythema, edema, or ulcers, and cannot eat • Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to original dose interval. • If after 2 weeks there …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Doxorubicin hydrochloride liposome injection: 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) in single-dose vials. The drug product appears as a translucent, red liposomal dispersion. Doxorubicin hydrochloride liposome injection: 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) in single-dose vials (3)
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions ( 5.2 )]. Hypersensitivity reactions to doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome injection ( 4 , 5.2 )
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Hand-Foot Syndrome may occur. Dose modification or discontinuation may be required ( 5.3 ) Embryofetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Use effective contraception ( 5.5, 8.1 , 8.3 ) 5.1 Cardiomyopathy Doxorubicin hydrochloride can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy with doxorubicin hydrochloride is generally proportional to the cumulative exposure. Include prior use of other anthracyclines or anthracenediones in calculations of cumulative dose. The risk of cardiomyopathy may be increased at lower cumulative doses inpatients with prior mediastinal irradiation. In a clinical study in 250 patients with advanced cancer who were treated with doxorubicin hydrochloride liposome injection, the risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 to 550 mg/m 2 . Cardiomyopathy was defined as >20% decrease in resting left ventricular ejection fraction (LVEF) from baseline where LVEF remained in the normal range or a >10% decrease in LVEF from baseline where LVEF was less than the institutional lower limit of normal. Two percent of patients developed signs and symptoms of congestive heart failure without documented evidence of cardiomyopathy. Assess left ventricular cardiac function (e.g. MUGA or echocardiogram) prior to initiation of doxorubicin hydrochloride liposome injection, during treatment to detect acute changes, and after treatment to detect delayed cardiomyopathy. Administer doxorubicin hydrochloride liposome injection to patients with a history of cardiovascular disease only when the potential benefit of treatment outweighs the risk. 5.2 Infusion-Related Reactions Serious, life-threatening, and fatal infusion-related reactions characterized by one or more of the following symptoms can occur with doxorubicin hydrochloride liposome injection: flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension. Of 239 patients with ovarian cancer treated with doxorubicin hydrochloride liposome injection in Trial 4, 7% of patients experienced acute infusion-related reactions resulting in dose interruption. All occurred during cycle 1 and none during subsequent cycles. Across multiple studies of doxorubicin hydrochloride liposome injection monotherapy including this and other studies enrolling 760 patients with various solid tumors, 11% of patients had infusion-related reactions. The majority of infusion-related events occurred during the first infusion. Ensure that medications to treat infusion-related reactions and cardiopulmonary resuscitative equipment are available for immediate use prior to initiation of doxorubicin hydrochloride liposome injection. Initiate doxorubicin hydrochloride liposome injection infusions at a rate of 1 mg/min and increase rate as tolerated [see Dosage and Administration ( 2.6 )]. Withhold doxorubicin hydrochloride liposome injection for Grade 1, 2, or 3 infusion-related actions and resume at a reduced infusion rate. Discontinue doxorubicin hydrochloride liposome injection infusion for serious or life-threatening infusion-related reactions. 5.3 Hand-Foot Syndrome (HFS) In Trial 4, the incidence of HFS was 51% of patients in the doxorubicin hydrochloride liposome injection arm and 0.9% of patients in the topotecan arm, including 24% Grade 3 or 4 cases of HFS in doxorubicin hydrochloride liposome injection-treated patients and no Grade 3 or 4 cases in topotecan-treated patients. HFS or other skin toxicity required discontinuation of doxorubicin hydrochloride liposome injection in 4.2% of patients. HFS was generally observed after 2 or 3 cycles of treatment but may occur earlier. Delay doxorubicin hydrochloride liposome injection for the first episode of Grade 2 or greater HFS [see Dosage and Ad …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. • Cardiomyopathy [see Warnings and Precautions ( 5.1 )] • Infusion-Related Reactions [see Warnings and Precautions ( 5.2 )] • Hand-Foot Syndrome [see Warnings and Precautions ( 5.3 )] • Secondary Oral Neoplasms [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>20%) are asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand and foot syndrome, rash, neutropenia, thrombocytopenia and anemia ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice. The safety data reflect exposure to doxorubicin hydrochloride liposome injection in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi’s sarcoma, and 318 patients with multiple myeloma. The most common adverse reactions (>20%) observed with doxorubicin hydrochloride liposome injection are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia. The following tables present adverse reactions from clinical trials of single-agent doxorubicin hydrochloride liposome injection in ovarian cancer and AIDS-Related Kaposi’s sarcoma. Patients With Ovarian Cancer The safety data described below are from Trial 4, which included 239 patients with ovarian cancer treated with doxorubicin hydrochloride liposome injection 50 mg/m 2 once every 4 weeks for a minimum of four courses in a randomized, multicenter, open-label study. In this trial, patients received doxorubicin hydrochloride liposome injection for a median number of 3.2 months (range 1 day to 25.8 months). The median age of the patients is 60 years (range 27 to 87), with 91% Caucasian, 6% Black, and 3% Hispanic or Other. Table 3 presents the hematologic adverse reactions from Trial 4. Table 3: Hematologic Adverse Reactions in Trial 4 Doxorubicin Hydrochloride Liposome Injection Patients (n=239) Topotecan Patients (n=235) Neutropenia 500 -<1000/mm 3 8% 14% <500/mm 3 4.2% 62% Anemia 6.5 -<8 g/dL 5% 25% < 6.5 g/dL 0.4% 4.3% Thrombocytopenia 10,000 -<50,000/mm 3 1.3% 17% <10,000/mm 3 0% 17% Table 4 presents the non-hematologic adverse reactions from Trial 4. Table 4: Non-Hematologic Adverse Reactions in Trial 4 Non-Hematologic Adverse Reaction 10% or Greater Doxorubicin Hydrochloride Liposome Injection (%) treated (n=239) Topotecan (%) treated (n=235) All grades Grades 3–4 All grades Grades 3–4 Body as a Whole Asthenia 40 7 52 8 Fever 21 0.8 31 6 Mucous Membrane Disorder 14 3.8 3.4 0 Back Pain 12 1.7 10 0.9 Infection 12 2.1 6 0.9 Headache 11 0.8 15 0 Digestive Nausea 46 5 63 8 Stomatitis 41 8 15 0.4 Vomiting 33 8 44 10 Diarrhea 21 2.5 35 4.2 Anorexia 20 2.5 22 1.3 Dyspepsia 12 0.8 14 0 Nervous Dizziness 4.2 0 10 0 Respiratory Pharyngitis 16 0 18 0.4 Dyspnea 15 4.1 23 4.3 Cough increased 10 0 12 0 Skin and Appendages Hand-foot syndrome 51 24 0.9 0 Rash 29 4.2 12 0.4 Alopecia 19 N/A 52 N/A The following additional adverse reactions were observed in patients with ovarian cancer with doses administered every four weeks (Trial 4). Incidence 1% to 10% Cardiovascular : vasodilation, tachycardia, deep vein thrombosis, hypotension, cardiac arrest. Digestive: oral moniliasis, mouth ulceration, esophagitis, dysphagia, rectal bleeding, ileus. Hematologic and Lymphatic : ecchymosis. Metabolic and Nutritional : dehydration, weight loss, hyperbilirubinemia, hypokalemia, hypercalcemia, hyponatremia. Nervous : somnolence, dizziness, depression. Respiratory : rhinitis, pneumonia, sinusitis, epista …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS No formal drug interaction studies have been conducted with doxorubicin hydrochloride liposome injection.
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Lactation: Discontinue breastfeeding ( 8.2 ). 8.1 Pregnancy Risk Summary Based on findings in animals and its mechanisms of action, doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride liposome injection during the 1 st trimester. In animal reproduction studies, doxorubicin hydrochloride liposome injection was embryotoxic in rats and abortifacient in rabbits following intravenous administration during organogenesis at doses approximately 0.12 times the recommended clinical dose [see Data].Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2 nd and the 3 rd trimesters. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Animal Data Doxorubicin hydrochloride liposome injection was embryotoxic at doses of 1 mg/kg/day in rats and was embryotoxic and abortifacient at 0.5 mg/kg/day in rabbits (both doses are about 0.12 times the recommended dose of 50 mg/m 2 human dose on a mg/m 2 basis). Embryotoxicity was characterized by increased embryo-fetal deaths and reduced live litter sizes. 8.2 Lactation Risk Summary It is not known whether doxorubicin hydrochloride liposome injection is present in human milk. Because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from doxorubicin hydrochloride liposome injection, discontinue breastfeeding during treatment with doxorubicin hydrochloride liposome injection. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating doxorubicin hydrochloride liposome injection. Contraception Females Doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )]. Advise females of reproductive potential to use effective contraception during and for 6 months after treatment with doxorubicin hydrochloride liposome injection. Males Doxorubicin hydrochloride liposome injection may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during and for 6 months after treatment with doxorubicin hydrochloride liposome injection [see Non-clinical Toxicology ( 13.1 )]. Infertility Females In females of reproductive potential, doxorubicin hydrochloride liposome injection may cause infertility and result in amenorrhea. Premature menopause can occur with doxorubicin hydrochloride. Recovery of menses and ovulation is related to age at treatment. Males Doxorubicin hydrochloride liposome injection may result in oligospermia, azoospermia, and permanent loss of fertility. Sperm counts have been reported to return to normal levels in some men. This may occur several years after the end of therapy [see Nonclinical Toxicology ( 13.1) ]. 8.4 Pediatric Use The safety and effectiveness of doxorubicin hydrochloride liposome injection in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of doxorubicin hydrochloride liposome injection conducted in patients with either epithelial ovarian cancer (Trial 4) or with AIDS-related Kaposi’s sarcoma (Trial 5) did not contain sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. In Trial 6, of 318 patients treated with doxorubicin hydrochloride liposome injection in combination with bortezomib for multiple …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action The active ingredient of doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride. The mechanism of action of doxorubicin hydrochloride is thought to be related to its ability to bind DNA and inhibit nucleic acid synthesis. Cell structure studies have demonstrated rapid cell penetration and perinuclear chromatin binding, rapid inhibition of mitotic activity and nucleic acid synthesis, and induction of mutagenesis and chromosomal aberrations.
Description
openFDA Drug Labeling11 DESCRIPTION The active ingredient in doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, USP, an anthracycline topoisomerase inhibitor, that is encapsulated in PEGYLATED liposomes for intravenous use. The chemical name of doxorubicin hydrochloride, USP is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C 27 -H 29 -NO 11 •HCl; its molecular weight is 579.99. The structural formula is: Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each vial contains 20 mg or 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin) and a pH of 6.5. The PEGYLATED liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine as a buffer; hydrochloric acid and/or sodium hydroxide for pH control; and sucrose to maintain isotonicity. Greater than 90% of the drug is encapsulated in the PEGYLATED liposomes. MPEG-DSPE has the following structural formula: n=ca. 45 HSPC has the following structural formula: m,n=14 or 16 Representation of a PEGYLATED liposome: stru MPEG HSPC PEGLYATED
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Acute overdosage with doxorubicin hydrochloride causes increased risk of severe mucositis, leukopenia, and thrombocytopenia.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each 10-mL vial contains 20 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL. Each 30-mL vial contains 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL. The following individually cartoned vials are available: Table 14 mg in vial fill volume vial size NDC #s 20 mg vial 10-mL 10-mL 68001-345-36 50 mg vial 25-mL 30-mL 68001-345-26 Refrigerate unopened vials of doxorubicin hydrochloride liposome injection at 2° C -8°C (36° F - 46°F). Do not freeze. Discard unused portion Doxorubicin hydrochloride liposome injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: DOXORUBICIN HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class I | June 17, 2026 | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of Particulate matter: Particulate matter identified as glass. | Ongoing |
| Class II | January 31, 2018 | Sun Pharmaceutical Industries, Inc. | Lack Of Assurance Of Sterility | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 68001-345-26 | 68001-345 | BluePoint Laboratories | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-26) / 25 mL in 1 VIAL, SINGLE-DOSE | February 16, 2018 |
| 68001-345-36 | 68001-345 | BluePoint Laboratories | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-36) / 10 mL in 1 VIAL, SINGLE-DOSE | February 16, 2018 |
| 68001-492-36 | 68001-492 | BluePoint Laboratories | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (68001-492-36) / 10 mL in 1 VIAL, SINGLE-DOSE | May 31, 2021 |
| 68001-493-26 | 68001-493 | BluePoint Laboratories | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (68001-493-26) / 25 mL in 1 VIAL, SINGLE-DOSE | May 31, 2021 |
| 68001-703-36 | 68001-703 | BluePoint Laboratories | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-703-36) / 10 mL in 1 VIAL, SINGLE-DOSE | April 2, 2026 |
| 68001-704-26 | 68001-704 | BluePoint Laboratories | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-704-26) / 25 mL in 1 VIAL, SINGLE-DOSE | April 2, 2026 |
| 72603-103-01 | 72603-103 | NorthStar RxLLC | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (72603-103-01) / 10 mL in 1 VIAL, SINGLE-DOSE | May 29, 2019 |
| 72603-200-01 | 72603-200 | NorthStar RxLLC | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (72603-200-01) / 25 mL in 1 VIAL, SINGLE-DOSE | May 29, 2019 |
| 47335-049-40 | 47335-049 | Sun Pharmaceutical Industries, Inc. | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-049-40) / 10 mL in 1 VIAL, SINGLE-DOSE | February 5, 2013 |
| 47335-050-40 | 47335-050 | Sun Pharmaceutical Industries, Inc. | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (47335-050-40) / 25 mL in 1 VIAL, SINGLE-DOSE | February 5, 2013 |
| 49315-008-03 | 49315-008 | Zydus Lifesciences Limited | 1 VIAL, SINGLE-DOSE in 1 CARTON (49315-008-03) / 10 mL in 1 VIAL, SINGLE-DOSE | September 14, 2020 |
| 49315-009-07 | 49315-009 | Zydus Lifesciences Limited | 1 VIAL, SINGLE-DOSE in 1 CARTON (49315-009-07) / 25 mL in 1 VIAL, SINGLE-DOSE | September 14, 2020 |
| 70710-1530-1 | 70710-1530 | Zydus Pharmaceuticals USA Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1530-1) / 10 mL in 1 VIAL, SINGLE-DOSE | September 14, 2020 |
| 70710-1531-1 | 70710-1531 | Zydus Pharmaceuticals USA Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1531-1) / 25 mL in 1 VIAL, SINGLE-DOSE | September 14, 2020 |
| 68001-345 | 68001-345 | BluePoint Laboratories | — | February 16, 2018 |
| 68001-492 | 68001-492 | BluePoint Laboratories | — | May 31, 2021 |
| 68001-493 | 68001-493 | BluePoint Laboratories | — | May 31, 2021 |
| 68001-703 | 68001-703 | BluePoint Laboratories | — | April 2, 2026 |
| 68001-704 | 68001-704 | BluePoint Laboratories | — | April 2, 2026 |
| 72603-103 | 72603-103 | NorthStar RxLLC | — | May 29, 2019 |
| 72603-200 | 72603-200 | NorthStar RxLLC | — | May 29, 2019 |
| 47335-049 | 47335-049 | Sun Pharmaceutical Industries, Inc. | — | February 5, 2013 |
| 47335-050 | 47335-050 | Sun Pharmaceutical Industries, Inc. | — | February 5, 2013 |
| 49315-008 | 49315-008 | Zydus Lifesciences Limited | — | September 14, 2020 |
| 49315-009 | 49315-009 | Zydus Lifesciences Limited | — | September 14, 2020 |
| 70710-1530 | 70710-1530 | Zydus Pharmaceuticals USA Inc. | — | September 14, 2020 |
| 70710-1531 | 70710-1531 | Zydus Pharmaceuticals USA Inc. | — | September 14, 2020 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.