Home › NDC Lookup › Ingredients › Doxorubicin Hydrochloride › 63323-0883-10
Doxorubicin Hydrochloride 2 mg/mL Injection, Solution — NDC 63323-0883-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doxorubicin Hydrochloride 2 mg/mL Injection, Solution — NDC 63323-883-10 (Billing 63323-0883-10)

by Fresenius Kabi USA, LLC · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of Doxorubicin Hydrochloride 2 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Apr 2000 and currently FDA-listed.

NDC 63323-0883-10
🏷️ FDA NDC (as labeled) 63323-883-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 vial, single-dose Pack sizes3 compare ↓
Product page 63323-0883-30 Also comes in: 5 mL 63323-883-05 25 mL 63323-883-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63323-883-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 883 product · 10 package
Package marketed since
Apr 14, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6332388310 2
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Doxorubicin Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · May 12, 2026 — Presence of Particulate matter: Particulate matter identified as glass. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0580-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-883-10
Product NDC 63323-883
11-digit billing NDC 63323088310
NCPDP billing unit ML — per mL (volume)
RxCUI 1191138, 1790097, 1790099, 1790100
UNII 82F2G7BL4E
Application # ANDA063277
SPL Set ID e0349f98-42fa-4003-b6d8-a1db1401b0ef
Established class (EPC) Anthracycline Topoisomerase Inhibitor
Mechanism of action Topoisomerase Inhibitors
Chemical class Anthracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-04-14
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DOXORUBICIN HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21200040102010
GPI class DOXOrubicin HCl
GCN Seq No 064126
GCN 99835
HICL code 003916
Ingredient (HICL) Doxorubicin Hcl
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1D
Therapeutic class — specific (HIC3) Antibiotic Antineoplastics
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name DOXORUBICIN 20 MG/10 ML VIAL
FDB brand name Doxorubicin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064126
  • GCN: 99835
  • GPI-14 (Medi-Span): 21200040102010
  • HICL (First Databank): 003916
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1191138
Why two NDCs? The FDA registers this code as 63323-883-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63323-0883-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anthracycline Topoisomerase Inhibitor class.

Pharmacologic class Anthracycline Topoisomerase Inhibitor
Drug family (ATC) Anthracyclines and related substances
How it works Topoisomerase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DOXORUBICIN 20 MG/10 ML VIAL Ingredient Doxorubicin Hcl
📖 What it is MedlinePlus · NLM

Doxorubicin is used in combination with other medications to treat certain types of bladder, breast, lung, stomach, and ovarian cancer; Hodgkin's lymphoma (Hodgkin's disease) and non-Hodgkin's lymphoma (cancer that begins in the cells of the immune system); and certain types of leukemia (cancer of the white blood cells), including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML, ANLL). Doxorubicin is also used alone and in combination with other medications to treat certain types of thyroid cancer and certain types of soft tissue or bone sarcomas (cancer that forms in muscle...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is a chemotherapy medicine for many cancers. Standard forms treat breast cancer, leukemias, lymphomas, and several spread cancers. Liposomal forms like Doxil treat ovarian cance...
  • A healthcare professional gives it into a vein in treatment cycles, usually every few weeks. You do not take it by mouth. Your team sets the exact schedule.
  • Tiredness, nausea, vomiting, mouth sores, diarrhea or constipation, rash, and low blood counts are common. Liposomal forms can cause hand-foot syndrome. Let your team know about an...
  • Call right away for fever or chills, unusual bleeding, shortness of breath, leg swelling, a racing heartbeat, or pain, redness, or swelling where the IV is. Heart problems can also...
📖 Read our full Doxorubicin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Doxorubicin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Doxorubicin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9000 $2.710 / J9000 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)63323-883-10
11-digit billing NDC63323-0883-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9000
DescriptorINJECTION, DOXORUBICIN HYDROCHLORIDE, 10 MG
Billing units / pkg0.2 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 10 MG, so one package = 0.2 billing units.
Medicare Part B spend (2026 (Q1))$97,446 · 4,382 claims · $22.24 per claim (all NDCs under J9000)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0883-05 63323-883-05 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE 2000-04-14 — Active
63323-0883-10 You're viewing this 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2000-04-14 — Active
63323-0883-30 63323-883-30 Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-DOSE 2000-04-14 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Doxorubicin Hydrochloride 2 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxorubicin Hydrochloride 2 mg/mL 49315-0008-03 Zydus 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 49315-0009-07 Zydus 1 vial — AB FDA listed —
DOXOrubicin Hydrochloride 2 mg/mL 62756-0826-40 Sun 1 vial — AP FDA listed —
DOXOrubicin Hydrochloride 2 mg/mL 62756-0827-40 Sun 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0345-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 16714-0742-01 NorthStar 1 vial — AB Discontinued —
Doxorubicin Hydrochloride 2 mg/mL 16714-0856-01 NorthStar 1 vial — AB Discontinued —
Doxorubicin Hydrochloride 2 mg/mL 00069-0343-02 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9085-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mLthis 63323-0883-10 Fresenius 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0492-36 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0704-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-0277-02 Pfizer 1 vial — AP FDA listed —
Doxorubicin hydrochloride 2 mg/mL 45963-0733-55 Actavis 1 vial — AP FDA listed —
Doxil 2 mg/mL 00338-0063-01 Baxter 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68083-0248-01 Gland 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-1442-04 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-3358-25 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-4031-12 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9084-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9090-01 Hikma 1 vial — AP FDA listed —
doxorubicin hydrochloride 2 mg/mL 62332-0810-10 Alembic 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68083-0249-01 Gland 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-1542-20 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 47335-0049-40 Sun 1 vial — AB FDA listed —
Doxil 2 mg/mL 00338-9665-01 Baxter 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0703-36 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70121-1219-01 Amneal 1 vial — AP FDA listed —
doxorubicin hydrochloride 2 mg/mL 75907-0363-01 Dr. 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-0358-20 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-4205-05 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9092-01 Hikma 1 vial — — FDA listed —
doxorubicin hydrochloride 2 mg/mL 46708-0810-10 Alembic 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 62332-0525-25 Alembic 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0493-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68001-0629-26 BluePoint 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70748-0340-01 Lupin 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-0255-10 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9086-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9087-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 72603-0103-01 NorthStar 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 72603-0200-01 NorthStar 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9091-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 67457-0436-50 Mylan 1 vial — — FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70710-1531-01 Zydus 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 75907-0364-01 Dr. 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00069-5629-05 Pfizer 1 vial — AP FDA listed —
Doxorubicin Hydrochloride Liposome 2 mg/mL 25021-0263-10 Sagent 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 46708-0525-25 Alembic 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 68083-0250-01 Gland 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 47335-0050-40 Sun 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 63323-0101-61 Fresenius 1 vial — AP FDA listed —
doxorubicin hydrochloride 2 mg/mL 25021-0207-25 Sagent 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9088-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9089-01 Hikma 1 vial — AP FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 00143-9093-01 Hikma 1 vial — — FDA listed —
doxorubicin hydrochloride, Liposomal 2 mg/mL 00338-9581-02 Baxter 1 vial — — FDA listed —
Doxil 2 mg/mL 00338-9667-01 Baxter 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70710-1530-01 Zydus 1 vial — AB FDA listed —
Doxorubicin Hydrochloride 2 mg/mL 70748-0339-01 Lupin 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 68001-0706-36 BluePoint 1 vial — AB FDA listed —
doxorubicin hydrochloride 2 mg/mL 68001-0707-26 BluePoint 1 vial — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2000
On the market since
Apr 2000
📍
2026
Currently FDA-listed
26 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Doxorubicin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 9 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA063277 (ANDA)
Labeler code63323
First marketedApr 2000
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information ⚠️ Precautions 🔬 Clinical Studies 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING Severe local tissue necrosis will occur if there is extravasation during administration (see DOSAGE AND ADMINISTRATION ). Doxorubicin must not be given by the intramuscular or subcutaneous route. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure (CHF) may occur either during therapy or months to years after termination of therapy.

The probability of developing impaired myocardial function based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m 2 of doxorubicin, 3 to 5% at a dose of 400 mg/m 2 , 5 to 8% at 450 mg/m 2 and 6 to 20% at 500 mg/m 2 . The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 400 mg/m 2 . Risk factors (active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, concomitant use of other cardiotoxic drugs) may increase the risk of cardiac toxicity.

Cardiac toxicity with doxorubicin may occur at lower cumulative doses whether or not cardiac risk factors are present. Pediatric patients are at increased risk for developing delayed cardiotoxicity. Secondary acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) has been reported in patients treated with anthracyclines, including doxorubicin (see ADVERSE REACTIONS ).

The occurrence of refractory secondary AML or MDS is more common when anthracyclines are given in combination with DNA-damaging anti-neoplastic agents or radiotherapy, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The rate of developing secondary AML or MDS has been estimated in an analysis of 8,563 patients with early breast cancer treated in 6 studies conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), including NSABP B-15.

Patients in these studies received standard doses of doxorubicin and standard or escalated doses of cyclophosphamide (AC) adjuvant chemotherapy and were followed for 61,810 patient years. Among 4,483 such patients who received conventional doses of AC, 11 cases of AML or MDS were identified, for an incidence of 0.32 cases per 1,000 patient years (95% Cl, 0.16 to 0.57) and a cumulative incidence at 5 years of 0.21% (95% Cl, 0.11 to 0.41%). In another analysis of 1,474 patients with breast cancer who received adjuvant treatment with doxorubicin-containing regimens in clinical trials conducted at University of Texas M.D.

Anderson Cancer Center, the incidence was estimated at 1.5% at 10 years. In both experiences, patients who received regimens with higher cyclophosphamide dosages, who received radiotherapy, or who were aged 50 or older had an increased risk of secondary AML or MDS. Pediatric patients are also at risk of developing secondary AML.

Dosage should be reduced in patients with impaired hepatic function. Severe myelosuppression may occur. Doxorubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

🎯 Indications and Usage 96 words ▾

INDICATIONS AND USAGE: Doxorubicin Hydrochloride Injection, USP has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms' tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin's disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.

Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION: When possible, to reduce the risk of developing cardiotoxicity in patients receiving doxorubicin after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, doxorubicin-based therapy should be delayed until the other agents have cleared from the circulation (see WARNINGS and PRECAUTIONS, General ). Care in the administration of doxorubicin will reduce the chance of perivenous infiltration (see WARNINGS ). It may also decrease the chance of local reactions such as urticaria and erythematous streaking.

On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying burning or stinging sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If extravasation is suspected, intermittent application of ice to the site for 15 min. q.i.d. x 3 days may be useful.

The benefit of local administration of drugs has not been clearly established. Because of the progressive nature of extravasation reactions, close observation and plastic surgery consultation is recommended. Blistering, ulceration and/or persistent pain are indications for wide excision surgery, followed by split-thickness skin grafting.

The most commonly used dose schedule when used as a single agent is 60 to 75 mg/m 2 as a single intravenous injection administered at 21-day intervals. The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration. Doxorubicin has been used concurrently with other approved chemotherapeutic agents.

Evidence is available that in some types of neoplastic disease, combination chemotherapy is superior to single agents. The benefits and risks of such therapy continue to be elucidated. When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m 2 given as a single intravenous injection every 21 to 28 days.

In a large randomized study (NSABP B-15) of patients with early breast cancer involving axillary lymph nodes (see CLINICAL PHARMACOLOGY , CLINICAL STUDIES and ADVERSE REACTIONS , Adverse Reactions in Patients with Early Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy ), the combination dosage regimen of AC (doxorubicin 60 mg/m 2 and cyclophosphamide 600 mg/m 2 ) was administered intravenously on day 1 of each 21-day treatment cycle. Four cycles of treatment were administered. Dose Modifications Patients in the NSABP B-15 study could have dose modifications of AC to 75% of the starting doses for neutropenic fever/infection.

When necessary, the next cycle of treatment cycle was delayed until the absolute neutrophil count (ANC) was ≥ 1,000 cells/mm 3 and the platelet count was ≥ 100,000 cells/mm 3 and nonhematologic toxicities had resolved. Doxorubicin dosage must be reduced in case of hyperbilirubinemia as follows: Plasma bilirubin concentration (mg/dL) Dosage reduction (%) 1.2 to 3 50 3.1 to 5 75 Reconstitution Directions It is recommended that doxorubicin be slowly administered into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.

The tubing should be attached to a Butterfly ® needle inserted preferably into a large vein. If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage. The rate of administration is dependent on the size of the vein and the dosage.

However, the dose should be administered in not less than 3 to 5 minutes. Local erythematous streaking along the vein as well as facial flushing may be indicative of too rapid an administration. A burning or stinging sensation may be indicative of perivenous infiltration and, if this occurs, the infusion should be immediately terminated and restarted… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 69 words ▾

CONTRAINDICATIONS: Patients should not be treated with doxorubicin if they have any of the following conditions: baseline neutrophil count <1,500 cells/mm 3 ; severe hepatic impairment; recent myocardial infarction; severe myocardial insufficiency; severe arrhythmias; previous treatment with complete cumulative doses of doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones; or hypersensitivity to doxorubicin, any of its excipients, or other anthracyclines or anthracenediones (see WARNINGS and DOSAGE AND ADMINISTRATION ).

⚠️ Warnings ~3 min read ▾

WARNINGS: General Doxorubicin should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Patients should recover from acute toxicities of prior cytotoxic treatment (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) before beginning treatment with doxorubicin. Also, initial treatment with doxorubicin should be preceded by a careful baseline assessment of blood counts; serum levels of total bilirubin, AST, and creatinine; and cardiac function as measured by left ventricular ejection function (LVEF).

Patients should be carefully monitored during treatment for possible clinical complications due to myelosuppression. Supportive care may be necessary for the treatment of severe neutropenia and severe infectious complications. Monitoring for potential cardiotoxicity is also important, especially with greater cumulative exposure to doxorubicin.

Doxorubicin may potentiate the toxicity of other anticancer therapies (see PRECAUTIONS , Drug Interactions ). Cardiac Function Cardiotoxicity is a known risk of anthracycline treatment. Anthracycline-induced cardiotoxicity may be manifested by early (or acute) or late (delayed) events.

Early cardiotoxicity of doxorubicin consists mainly of sinus tachycardia and/or electrocardiogram (ECG) abnormalities such as non-specific ST-T wave changes. Tachyarrhythmias, including premature ventricular contractions and ventricular tachycardia, bradycardia, as well as atrioventricular and bundle-branch block have also been reported. These effects do not usually predict subsequent development of delayed cardiotoxicity, are rarely of clinical importance, and are generally not considered an indication for the suspension of doxorubicin treatment.

Delayed cardiotoxicity usually develops late in the course of therapy with doxorubicin or within 2 to 3 months after treatment termination, but later events, several months to years after completion of treatment, have also been reported. Delayed cardiomyopathy is manifested by a reduction in LVEF and/or signs and symptoms of congestive heart failure (CHF) such as tachycardia, dyspnea, pulmonary edema, dependent edema, cardiomegaly and hepatomegaly, oliguria, ascites, pleural effusion, and gallop rhythm. Subacute effects such as pericarditis/myocarditis have also been reported.

Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug. The probability of developing impaired myocardial function, based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m 2 of doxorubicin, 3 to 5% at a dose of 400 mg/m 2 , 5 to 8% at a dose of 450 mg/m 2 and 6 to 20% at a dose of 500 mg/m 2 given in a schedule of a bolus injection once every 3 weeks.

In a retrospective review, the probability of developing congestive heart failure was reported to be 5/168 (3%) at a cumulative dose of 430 mg/m 2 of doxorubicin, 8/110 (7%) at 575 mg/m 2 , and 3/14 (21%) at 728 mg/m 2 . In a prospective study of doxorubicin in combination with cyclophosphamide, fluorouracil and/or vincristine in patients with breast cancer or small cell lung cancer, the probability of CHF at various cumulative doses of doxorubicin was 1.5% at 300 mg/m 2 , 4.9% at 400 mg/m 2 , 7.7% at 450 mg/m 2 and 20.5% at 500 mg/m 2 .

The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 400 mg/m 2 . Cardiotoxicity may occur at lower doses in patients with prior mediastinal/pericardial irradiation, concomitant use of other cardiotoxic drugs, doxorubicin exposure at an early age, and advanced age. Data also suggest that pre-existing heart disease is a co-factor for increased risk of doxorubicin cardiotoxicity.

In such cases, cardiac toxicity may occur at doses lower than the recommended cumulative dos… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS: Dose limiting toxicities of therapy are myelosuppression and cardiotoxicity. Other reactions reported are: Cardiotoxicity (See WARNINGS ). Cutaneous Reversible complete alopecia occurs in most cases.

Hyperpigmentation of nailbeds and dermal creases, primarily in pediatric patients, and onycholysis have been reported in a few cases. Radiation recall reaction has occurred with doxorubicin administration. Rash, itching, or photosensitivity may occur.

Gastrointestinal Acute nausea and vomiting occurs frequently and may be severe. This may be alleviated by antiemetic therapy. Mucositis (stomatitis and esophagitis) may occur within 5 to 10 days of beginning therapy, and most patients recover from this adverse event within another 5 to 10 days.

The effect may be severe leading to ulceration and represents a site of origin for severe infections. The dosage regimen consisting of administration of doxorubicin on three successive days results in greater incidence and severity of mucositis. Ulceration and necrosis of the colon, especially the cecum, may occur leading to bleeding or severe infections which can be fatal.

This reaction has been reported in patients with acute non-lymphocytic leukemia treated with a 3-day course of doxorubicin combined with cytarabine. Anorexia, abdominal pain, dehydration, diarrhea, and hyperpigmentation of the oral mucosa have been occasionally reported. Hematologic (See WARNINGS ).

Hypersensitivity Fever, chills and urticaria have been reported occasionally. Anaphylaxis may occur. A case of apparent cross sensitivity to lincomycin has been reported.

Neurological Peripheral neurotoxicity in the form of local-regional sensory and/or motor disturbances have been reported in patients treated intra-arterially with doxorubicin, mostly in combination with cisplatin. Animal studies have demonstrated seizures and coma in rodents and dogs treated with intra-carotid doxorubicin. Seizures and coma have been reported in patients treated with doxorubicin in combination with cisplatin or vincristine.

Ocular Conjunctivitis, keratitis, and lacrimation occur rarely. Other Malaise/asthenia have been reported. Adverse Reactions in Patients with Early Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy Safety data were collected from approximately 2,300 women who participated in a randomized, open-label trial (NSABP B-15) evaluating the use of AC versus CMF in the treatment of early breast cancer involving axillary lymph nodes.

In the safety analysis, the follow-up data from all patients receiving AC were combined (N=1,492 evaluable patients) and compared with data from patients receiving conventional CMF (i.e., oral cyclophosphamide; N=739 evaluable patients). The most relevant adverse events reported in this study are provided in Table 2. Table 2.

Relevant Adverse Events in Patients with Early Breast Cancer Involving Axillary Lymph Nodes AC* Conventional CMF N=1,492 N=739 Treatment administration Mean number of cycles 3.8

5.5Total cycles 5,676 4,068 Adverse events, % of patients Leukopenia Grade 3 (1,000 to 1,999 /mm 3 ) 3.4

9.4Grade 4 (<1000/mm 3 ) 0.3

0.3 Thrombocytopenia Grade 3 (25,000 to 49,999 /mm 3 ) 0

0.3Grade 4 (<25,000 /mm 3 ) 0.1 0 Shock, sepsis 1.5

0.9Systemic infection 2.4

1.2Nausea and vomiting Nausea only 15.5

42.8Vomiting ≤ 12 hours 34.4

25.2Vomiting >12 hours 36.8 12 Intractable 4.7

1.6Alopecia 92.4

71.4Partial 22.9

56.3Complete 69.5

15.1Weight loss 5 to 10% 6.2 5.7 >10% 2.4

2.8Weight gain 5 to 10% 10.6 27.9 >10% 3.8

14.3Cardiac function Asymptomatic 0.2

0.1Transient 0.1 0 Symptomatic 0.1 0 Treatment-related death 0 0 * Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF

Cardiotoxicity (See WARNINGS ).

Cutaneous Reversible complete alopecia occurs in most cases. Hyperpigmentation of nailbeds and dermal creases, primarily in pediatric patients, and onycholysis have been… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 106 words ▾

OVERDOSAGE: Acute overdosage with doxorubicin enhances the toxic effects of mucositis, leukopenia and thrombocytopenia. Treatment of acute overdosage consists of treatment of the severely myelosuppressed patient with hospitalization, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of hemopoietic growth factor (G-CSF, GM-CSF) may be considered.

The 200 mg doxorubicin hydrochloride injection vial is packaged as a multiple dose vial and caution should be exercised to prevent inadvertent overdosage. Cumulative dosage with doxorubicin increases the risk of cardiomyopathy and resultant congestive heart failure (see WARNINGS ). Treatment consists of vigorous management of congestive heart failure with digitalis preparations, diuretics, and after-load reducers such as ACE inhibitors.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY: The cytotoxic effect of doxorubicin on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases. The interaction of doxorubicin with topoisomerase II to form DNA-cleavable complexes appears to be an important mechanism of doxorubicin cytocidal activity.

Doxorubicin cellular membrane binding may affect a variety of cellular functions. Enzymatic electron reduction of doxorubicin by a variety of oxidases, reductases and dehydrogenases generates highly reactive species including the hydroxyl free radical OH•. Free radical formation has been implicated in doxorubicin cardiotoxicity by means of Cu (II) and Fe (III) reduction at the cellular level.

Cells treated with doxorubicin have been shown to manifest the characteristic morphologic changes associated with apoptosis or programmed cell death. Doxorubicin-induced apoptosis may be an integral component of the cellular mechanism of action relating to therapeutic effects, toxicities, or both. Animal studies have shown activity in a spectrum of experimental tumors, immunosuppression, carcinogenic properties in rodents, induction of a variety of toxic effects, including delayed and progressive cardiac toxicity, myelosuppression in all species and atrophy to testes in rats and dogs.

Pharmacokinetics Pharmacokinetic studies, determined in patients with various types of tumors undergoing either single or multi-agent therapy have shown that doxorubicin follows a multiphasic disposition after intravenous injection. In four patients, doxorubicin has demonstrated dose-independent pharmacokinetics in the dose range of 30 to 70 mg/m 2 . Distribution The initial distribution half-life of approximately 5 minutes suggests rapid tissue uptake of doxorubicin, while its slow elimination from tissues is reflected by a terminal half-life of 20 to 48 hours.

Steady-state distribution volume ranges from 809 to 1,214 L/m 2 and is indicative of extensive drug uptake into tissues. Binding of doxorubicin and its major metabolite, doxorubicinol, to plasma proteins is about 74 to 76% and is independent of plasma concentration of doxorubicin up to 1.1 mcg/mL. Doxorubicin was excreted in the milk of one lactating patient, with peak milk concentration at 24 hours after treatment being approximately 4.4-fold greater than the corresponding plasma concentration.

Doxorubicin was detectable in the milk up to 72 hours after therapy with 70 mg/m 2 of doxorubicin given as a 15-minute intravenous infusion and 100 mg/m 2 of cisplatin as a 26-hour intravenous infusion. The peak concentration of doxorubicinol in milk at 24 hours was 0.11 mcg/mL and AUC up to 24 hours was 9 mcg•h/mL while the AUC for doxorubicin was 5.4 mcg•h/mL. Doxorubicin does not cross the blood brain barrier.

Metabolism Enzymatic reduction at the 7 position and cleavage of the daunosamine sugar yields aglycones which are accompanied by free radical formation, the local production of which may contribute to the cardiotoxic activity of doxorubicin. Disposition of doxorubicinol (DOX-OL) in patients is formation rate limited, with the terminal half-life of DOX-OL being similar to doxorubicin. The relative exposure of DOX-OL, i.e., the ratio between the AUC of DOX-OL and the AUC of doxorubicin, compared to doxorubicin ranges between 0.4 and 0.6.

Excretion Plasma clearance is in the range 324 to 809 mL/min/m 2 and is predominately by metabolism and biliary excretion. Approximately 40% of the dose appears in the bile in 5 days, while only 5 to 12% of the drug and its metabolites appear in the urine during the same time period. In urine, < 3% of the dose was recovered as DOX-OL over 7 days.

Systemic clearance of doxorubicin is significantly reduced in obese women with ideal body weight greater than 130%. There was a significant reduction in cle… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 123 words ▾

HOW SUPPLIED: Doxorubicin Hydrochloride Injection, USP, 2 mg per mL, a sterile product which contains no preservatives, is available as follows: Product No. NDC No. 88305 63323-883-05 Doxorubicin hydrochloride 10 mg in a 5 mL single dose flip-top vial, packaged individually.

88310 63323-883-10 Doxorubicin hydrochloride 20 mg in a 10 mL single dose flip-top vial, packaged individually. 88330 63323-883-30 Doxorubicin hydrochloride 50 mg in a 25 mL single dose flip-top vial, packaged individually. 100161 63323-101-61 Doxorubicin hydrochloride 200 mg in a 100 mL multiple dose vial, packaged individually.

REFRIGERATE AT: 2 ° to 8 °C ( 36 ° to 46 °F). Protect from light (keep in outer carton). Preservative Free.

Discard unused portion. The container closure is not made with natural rubber latex.

📋 Description ~1 min read ▾

DESCRIPTION: Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var . caesius . Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine. Chemically, doxorubicin hydrochloride is: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L- lyxo -hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8 S - cis )-.

(8 S , 10 S )-10-[(3-Amino-2,3,6-trideoxy-α-L- lyxo -hexopyranosyl)-oxy]-8-glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride [ 25316-40-9 ]. The structural formula is as follows: C 27 H 29 NO 11 • HCl M.W. 579.99 Doxorubicin binds to nucleic acids, presumably by specific intercalation of the planar anthracycline nucleus with the DNA double helix.

The anthracycline ring is lipophilic, but the saturated end of the ring system contains abundant hydroxyl groups adjacent to the amino sugar, producing a hydrophilic center. The molecule is amphoteric, containing acidic functions in the ring phenolic groups and a basic function in the sugar amino group. It binds to cell membranes as well as plasma proteins.

Doxorubicin Hydrochloride Injection, USP is a sterile, isotonic, preservative-free solution for intravenous use. It is available in 5 mL (10 mg), 10 mL (20 mg) and 25 mL (50 mg) single dose vials and 100 mL (200 mg) multiple dose vials. Each mL contains: Doxorubicin hydrochloride 2 mg; sodium chloride 9 mg for Isotonicity: Water for Injection q.s.

Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). structure

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Doxorubicin (dakse-RU-besen) Hydrochloride Injection, USP Read this Patient information before you start receiving doxorubicin and before each infusion. This information leaflet does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about doxorubicin?

Doxorubicin may cause serious side effects including: • Heart problems. Doxorubicin may cause heart problems that may lead to death. These problems can happen during your treatment or months to years after stopping treatment.

In some cases heart problems are irreversible. Your chance of heart problems is higher if you: • already have heart problems • have a history of radiation therapy or are currently receiving radiation therapy to your chest • have had treatment with certain other anti-cancer medicines • take other medicines that can affect your heart Tell your doctor if you get any of these symptoms of heart problems: • shortness of breath • cough • swelling of your feet and ankles • fast heartbeat Your doctor should do tests to check your heart before, during, and after your treatment with doxorubicin. • Secondary cancers.

Some people who have received doxorubicin have developed acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). Your chance of developing a secondary cancer is higher if you receive doxorubicin along with other anti-cancer medicines or with radiation therapy. • Decreased blood cell counts. Doxorubicin can cause a severe decrease in neutrophils (a type of white blood cells important in fighting in bacterial infections), red blood cells (blood cells that carry oxygen to the tissues), and platelets (important for clotting and to control bleeding).Your doctor will check your blood cell count during your treatment with doxorubicin and after you have stopped your treatment.

What is doxorubicin? Doxorubicin is a prescription anti-cancer medicine used to treat certain types of cancers. Doxorubicin may be used alone or along with other anti-cancer medicines.

Who should not receive doxorubicin? Do not receive doxorubicin if: • your blood cell counts are too low: platelets (which help your blood to clot), red blood cells (which help to carry iron and oxygen throughout your body), and white blood cells (which help to fight infection) • you have a severe liver problem • you have had a recent heart attack or have severe heart problems • you have had previous treatment with doxorubicin or certain other anticancer medicines and received the maximum dose allowed • you are allergic to certain other anti-cancer medicines, doxorubicin hydrochloride, or any other ingredient in Doxorubicin Hydrochloride Injection, USP.

See the end of this leaflet for a complete list of ingredients in Doxorubicin Hydrochloride Injection, USP. Talk to your doctor before receiving doxorubicin if you have any of the conditions listed above. What should I tell my doctor before receiving doxorubicin?

Before you receive doxorubicin, tell your doctor if you: • have heart problems • have had radiation treatment or currently receiving radiation therapy • are over the age of 50 • have liver problems • plan to receive any vaccines. Talk to your doctor about which vaccines are safe for you to receive during your treatment with doxorubicin. See “What should I avoid while receiving doxorubicin?” • have any other medical conditions • are pregnant or plan to become pregnant.

Doxorubicin can harm your unborn baby. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving doxorubicin. • are breastfeeding or plan to breast feed.

Doxorubicin can pass into your breast milk and harm your baby. You and your doctor should decide if you will receive doxorubicin or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription m… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~3 min read ▾

PRECAUTIONS: General Doxorubicin is not an anti-microbial agent. Doxorubicin is emetigenic. Antiemetics may reduce nausea and vomiting; prophylactic use of antiemetics should be considered before administration of doxorubicin, particularly when given in conjunction with other emetigenic drugs.

Doxorubicin should not be administered in combination with other cardiotoxic agents unless the patient's cardiac function is closely monitored. Patients receiving doxorubicin after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, may also be at an increased risk of developing cardiotoxicity. Physicians should avoid doxorubicin-based therapy for up to 24 weeks after stopping trastuzumab when possible.

If doxorubicin used before this time, careful monitoring of cardiac function is recommended (see WARNINGS , DOSAGE AND ADMINISTRATION ). Information for Patients Patients should be informed of the expected adverse effects of doxorubicin, including gastrointestinal symptoms (nausea, vomiting, diarrhea, and stomatitis) and potential neutropenic complications. Patients should consult their physician if vomiting, dehydration, fever, evidence of infection, symptoms of CHF, or injection-site pain occurs following therapy with doxorubicin.

Patients should be informed that they will almost certainly develop alopecia. Patients should be advised that their urine may appear red for 1 to 2 days after administration of doxorubicin and that they should not be alarmed. Patients should understand that there is a risk of irreversible myocardial damage associated with treatment with doxorubicin, as well as a risk of treatment-related leukemia.

Because doxorubicin may induce chromosomal damage in sperm, men undergoing treatment with doxorubicin should use effective contraceptive methods. Women treated with doxorubicin may develop irreversible amenorrhea, or premature menopause. Drug Interactions Doxorubicin is extensively metabolized by the liver.

Changes in hepatic function induced by concomitant therapies may affect doxorubicin metabolism, pharmacokinetics, therapeutic efficacy, and/or toxicity. Toxicities associated with doxorubicin, especially hematologic and gastrointestinal events, may be increased when doxorubicin is used in combination with other cytotoxic drugs. Paclitaxel There have been a number of reports in the literature that describe an increase in cardiotoxicity when doxorubicin is co-administered with paclitaxel.

Two published studies report that initial administration of paclitaxel infused over 24 hours followed by doxorubicin administered over 48 hours resulted in a significant decrease in doxorubicin clearance with more profound neutropenic and stomatitis episodes than the reverse sequence of administration. Progesterone In a published study, progesterone was given intravenously to patients with advanced malignancies (ECOG PS< 2) at high doses (up to 10 g over 24 hours) concomitantly with a fixed doxorubicin dose (60 mg/m 2 ) via bolus injection.

Enhanced doxorubicin-induced neutropenia and thrombocytopenia were observed. Verapamil A study of the effects of verapamil on the acute toxicity of doxorubicin in mice revealed higher initial peak concentrations of doxorubicin in the heart with a higher incidence and severity of degenerative changes in cardiac tissue resulting in a shorter survival. Cyclosporine The addition of cyclosporine to doxorubicin may result in increases in AUC for both doxorubicin and doxorubicinol possibly due to a decrease in clearance of parent drug and a decrease in metabolism of doxorubicinol.

Literature reports suggest that adding cyclosporine to doxorubicin results in more profound and prolonged hematologic toxicity than doxorubicin alone. Coma and/or seizures have also been described. Dexrazoxane In a clinical study of women with metastatic breast cancer, the concurrent use of the cardioprotectant, dexrazoxane, with the initiation of a regimen of fluoroura… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

CLINICAL STUDIES: The effectiveness of doxorubicin-containing regimens in the adjuvant therapy of early breast cancer has primarily been established based on data collected in a meta-analysis published in 1998 by the Early Breast Cancer Trialists Collaborative Group (EBCTCG). The EBCTCG obtains primary data on all relevant studies, both published and unpublished, for early stage breast cancer and regularly updates these analyses. The principal endpoints for the adjuvant chemotherapy trials were disease-free survival (DFS) and overall survival (OS).

The meta-analyses allowed comparisons of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) to no chemotherapy (19 trials including 7,523 patients) and comparisons of doxorubicin-containing regimens with CMF as an active control (6 trials including 3,510 patients). The pooled estimates of DFS and OS from these trials were used to calculate the effect of CMF relative to no therapy. The hazard ratio for DFS for CMF compared to no chemotherapy was 0.76 (95% Cl, 0.71 to 0.82) and for OS was 0.86 (95% Cl, 0.8 to 0.93).

Based on a conservative estimate of CMF effect (lower 2-sided 95% confidence limit of hazard ratio) and 75% retention of CMF effect on DFS, it was determined that the doxorubicin-containing regimens would be considered as non-inferior to CMF if the upper 2-sided 95% confidence limit of the hazard ratio was less than 1.06, i.e., not more than 6% worse than CMF. A similar calculation for OS would require a non-inferiority margin of 1.02. Six randomized trials in the EBCTCG meta-analysis compared doxorubicin-containing regimens to CMF.

A total of 3,510 women with early breast cancer involving axillary lymph nodes were evaluated; approximately 70% were premenopausal and 30% were postmenopausal. At the time of the meta-analysis, 1,745 first recurrences and 1,348 deaths had occurred. Analyses demonstrated that doxorubicin-containing regimens retained at least 75% of the historical CMF adjuvant effect on DFS and are effective.

The hazard ratio for DFS (dox:CMF) was 0.91 (95% Cl, 0.82 to 1.01) and for OS was 0.91 (95% Cl, 0.81 to 1.03). Results of these analyses for both DFS and OS are provided in Table 1 and Figures 1 and 2. Table 1.

Summary of Randomized Trials Comparing Doxorubicin-Containing Regimens Versus CMF in EBCTCG Meta-Analysis Study (starting year) Regimens No. of Cycles No. of Patients Doxorubicin-Containing Regimens vs CMF HR (95% CI) DFS OS NSABP B-15 (1984) AC 4 1,562* 0.93 (0.82 to 1.06) 0.97 (0.83 to 1.12) CMF 6 776 SECSG 2 (1976) FAC 6 260 0.86 (0.66 to 1.13) 0.93 (0.69 to 1.26) CMF 6 268 ONCOFRANCE (1978) FACV 12 138 0.71 (0.49 to 1.03) 0.65 (0.44 to 0.96) CMF 12 113 SE Sweden BCG A (1980) AC 6 21 0.59 (0.22 to 1.61) 0.53 (0.21 to 1.37) CMF 6 22 NSABC Israel Br0283 (1983) AVbCMF † CMF 4 6 6 55 50 0.91 (0.53 to 1.57) 0.88 (0.47 to 1.63) Austrian BCSG 3 (1984) CMFVA 6 121 1.07 (0.73 to 1.55) 0.93 (0.64 to 1.35) CMF 8 124 Combined Studies Doxorubicin-Containing Regimens 2,157 0.91 (0.82 to 1.01) 0.91 (0.81 to 1.03) CMF 1,353 Abbreviations: DFS = disease free survival; OS = overall survival; AC = doxorubicin, cyclophosphamide; AVbCMF = doxorubicin, vinblastine, cyclophosphamide, methotrexate, 5-fluorouracil; CMF = cyclophosphamide, methotrexate, 5-fluorouracil; CMFVA = cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, doxorubicin; FAC = 5-fluorouracil, doxorubicin, cyclophosphamide; FACV = 5-fluorouracil, doxorubicin, cyclophosphamide, vincristine; HR = hazard ratio; CI = confidence interval _________________________________________________________________________________________________________________________ * Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF. † Patients received alternating cycles of AVb and CMF.

With respect to DFS, 2 of 6 studies (NSABP B-15 and ONCOFRANCE) met the non-inferiority standard individually and with respect to OS, 1 st… [Excerpted — this section continues on DailyMed.]

📚 References 120 words ▾

REFERENCES: NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S.

Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2.

Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://osha.gov/dts/osta/otm/otm_vi/otm _vi_2.html American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs.

Am J Health-Syst Pharm. 2006; 63:1172-1193. Polovich, M., White, J.

M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for human practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

The brand names mentioned in this document are the trademarks of their respective owners.

📄 Package Label / Principal Display Panel 162 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Doxorubicin 5 mL Single Dose Vial Label DOXOrubicin Hydrochloride Injection, USP 10 mg per 5 mL (2 mg per mL) For intravenous use only. Preservative free. 5 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Doxorubicin 5 mL Single Dose Vial Carton Panel DOXOrubicin Hydrochloride Injection, USP 10 mg per 5 mL (2 mg per mL) For intravenous use only.

Preservative free. Rx only 5 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Doxorubicin 100 mL Multiple Dose Vial Label DOXOrubicin Hydrochloride Injection, USP 200 mg per 100 mL (2 mg per mL) For intravenous use only. Preservative free.

100 mL Multiple Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Doxorubicin 100 mL Multiple Dose Vial Carton Panel DOXOrubicin Hydrochloride Injection, USP 200 mg per 100 mL (2 mg per mL) For intravenous use only. Preservative free. Rx only 100 mL Multiple Dose Vial vial pbox vial pbox

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial63323-0883-30 627 Rx · $62,769
1 vial63323-0883-05 92 Rx · $1,869
1 vial this page63323-0883-10 No Medicaid data
Drug total (last 4 qtrs): 719 Rx · 25,423 units · $64,638 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 vial (63323-0883-05), 1 vial (63323-0883-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9000 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63323-0881-16 · Fresenius 63323-0884-06 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.