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Daunorubicin Hydrochloride 5 mg/mL Injection, Solution — NDC 42658-0021-92 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Daunorubicin Hydrochloride 5 mg/mL Injection, Solution — NDC 42658-021-92 (Billing 42658-0021-92)

by Hisun Pharmaceuticals USA, Inc. · 10 VIAL in 1 CARTON / 4 mL in 1 VIAL

This is a package of Daunorubicin Hydrochloride 5 mg/mL Injection, Solution from Hisun Pharmaceuticals USA, Inc., marketed since Jan 2020 and currently FDA-listed.

NDC 42658-0021-92
🏷️ FDA NDC (as labeled) 42658-021-92 billing pads the product segment with a zero
This package
Contains4 mL in 1 vial Pack sizes4 compare ↓
Product page 42658-0021-01 Also comes in: 4 mL 42658-021-01 4 mL 42658-021-91 10 vials 42658-021-02
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 42658-021-92 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
42658 labeler · 021 product · 92 package
Package marketed since
Dec 19, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0342658021014, 0342658019011
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42658-021-92
Product NDC 42658-021
11-digit billing NDC 42658002192
NCPDP billing unit ML — per mL (volume)
RxCUI 309650, 2002002
UNII UD984I04LZ
UPC 0342658021014, 0342658019011
Application # ANDA208759
SPL Set ID 9705fa12-499e-41a3-8fb4-f6df0858b851
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 2020-01-20
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DAUNORUBICIN HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 21200030102025
GPI class DAUNOrubicin HCl
GCN Seq No 039056
GCN 38623
HICL code 003919
Ingredient (HICL) Daunorubicin 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 DAUNORUBICIN 20 MG/4 ML VIAL
FDB brand name Daunorubicin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 039056
  • GCN: 38623
  • GPI-14 (Medi-Span): 21200030102025
  • HICL (First Databank): 003919
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 309650
Why two NDCs? The FDA registers this code as 42658-021-92 — 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 → 42658-0021-92. 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 DAUNORUBICIN 20 MG/4 ML VIAL Ingredient Daunorubicin Hcl
📗 Our plain-language guide HelloPharmacist
  • Daunorubicin is a chemotherapy drug used to treat two types of leukemia — acute nonlymphocytic leukemia in adults, and acute lymphocytic leukemia in both children and adults. It's...
  • You'll receive daunorubicin through an IV — directly into a vein — at a hospital or cancer clinic. It's never given as a pill and must never be injected into muscle or skin. Treatm...
  • Most people experience hair loss (which usually grows back), mild nausea and vomiting, and mouth sores a few days after treatment. These are expected and manageable. However, you s...
  • What side effects are most likely, and which ones should I call about right away?
📖 Read our full Daunorubicin guide →
1
Nutrient depletion considerations

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

🧪 Full Daunorubicin Citrate 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 · J9150 $28.810 / J9150 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)42658-021-92
11-digit billing NDC42658-0021-92
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9150
DescriptorINJECTION, DAUNORUBICIN, 10 MG
Billing units / pkg0.5 units
How the units are derivedThis package is 4 ML; the HCPCS unit is 10 MG, so one package = 0.5 billing units.
Medicare Part B spend (2025 (Q1-Q4))$2,693 · 17 claims · $158.39 per claim (all NDCs under J9150)
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
42658-0021-01 42658-021-01 Main listing 1 VIAL in 1 BOX / 4 mL in 1 VIAL 2020-01-20 — Active
42658-0021-02 42658-021-02 10 VIAL in 1 CARTON / 4 mL in 1 VIAL 2021-01-27 — Active
42658-0021-91 42658-021-91 1 VIAL in 1 BOX / 4 mL in 1 VIAL 2023-01-15 — Active
42658-0021-92 You're viewing this 10 VIAL in 1 CARTON / 4 mL in 1 VIAL 2022-12-19 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 vial in 1 carton / 4 ml in 1 vial.
What NDC number is used to bill for this package of Daunorubicin Hydrochloride 5 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
Daunorubicin Hydrochloride 5 mg/mL 00143-9551-10 Hikma 10 vials — AP FDA listed —
Daunorubicin Hydrochloride 5 mg/mLthis 42658-0021-92 Hisun 10 vials — AP FDA listed —
daunorubicin hydrochloride 5 mg/mL 71288-0182-05 Meitheal 10 vials — AP FDA listed —
Daunorubicin Hydrochloride 5 mg/mL 00143-9550-01 Hikma 1 vial — AP FDA listed —
Daunorubicin Hydrochloride 5 mg/mL 42658-0019-01 Hisun 1 vial — AP 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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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 Daunorubicin 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.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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

LabelerHisun Pharmaceuticals USA, Inc.
Application holderHISUN PHARMACEUTICAL HANGZHOU CO LTD
FDA applicationANDA208759 (ANDA)
Labeler code42658
First marketedJan 2020
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from Hisun Pharmaceuticals USA, Inc. labeler code 42658

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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 190 words ▾

WARNING Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration.

Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m 2 in adults, 300 mg/m 2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage.

It is recommended that daunorubicin hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. Dosage should be reduced in patients with impaired hepatic or renal function.

🎯 Indications and Usage 39 words ▾

INDICATIONS AND USAGE Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Principles In order to eradicate the leukemic cells and induce a complete remission, a profound suppression of the bone marrow is usually required. Evaluation of both the peripheral blood and bone marrow is mandatory in the formulation of appropriate treatment plans.

It is recommended that the dosage of daunorubicin hydrochloride injection be reduced in instances of hepatic or renal impairment. For example, using serum bilirubin and serum creatinine as indicators of liver and kidney function, the following dose modifications are recommended: Serum Bilirubin Serum Creatinine Dose Reduction 1.2 to 3 mg% — 25% >3 mg% — 50% — >3 mg% 50% Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia: In Combination For patients under age 60, daunorubicin hydrochloride injection 45 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses.

For patients 60 years of age and above, daunorubicin hydrochloride injection 30 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. This daunorubicin hydrochloride injection dose-reduction is based on a single study and may not be appropriate if optimal supportive care is available. The attainment of a normal-appearing bone marrow may require up to three courses of induction therapy.

Evaluation of the bone marrow following recovery from the previous course of induction therapy determines whether a further course of induction treatment is required. Representative Dose Schedule and Combination for the Approved Indication of Remission Induction in Pediatric Acute Lymphocytic Leukemia: In Combination Daunorubicin hydrochloride injection 25 mg/m 2 IV on day 1 every week, vincristine 1.5 mg/m 2 IV on day 1 every week, prednisone 40 mg/m 2 PO daily. Generally, a complete remission will be obtained within four such courses of therapy; however, if after four courses the patient is in partial remission, an additional one or, if necessary, two courses may be given in an effort to obtain a complete remission.

In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the daunorubicin hydrochloride injection dosage calculation should be based on weight (1 mg/kg) instead of body surface area. Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Lymphocytic Leukemia: In Combination Daunorubicin hydrochloride injection 45 mg/m 2 /day IV on days 1, 2, and 3 AND vincristine 2 mg IV on days 1, 8, and 15; prednisone 40 mg/m 2 /day PO on days 1 through 22, then tapered between days 22 to 29; L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32.

The sterile vial contents provide 20 mg or 50 mg of daunorubicin, with 5 mg of daunorubicin per mL. The desired dose is withdrawn into a syringe containing 10 mL to 15 mL of 0.9% Sodium Chloride Injection, USP and then injected into the tubing or sidearm in a rapidly flowing IV infusion of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Daunorubicin hydrochloride injection should not be administered mixed with other drugs or heparin.

Storage and Handling Store unopened vials in refrigerator, 2° to 8°C (36° to 46°F). Store prepared solution for infusion at room temperature, 15° to 30°C (59° to 86°F) for up to 24 hours. Contains no preservative.

Discard unused portion. Protect from light. If daunorubicin hydrochloride injection contacts the skin or mucosae, the area should be washed t… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS Daunorubicin hydrochloride injection is contraindicated in patients who have shown a hypersensitivity to it.

⚠️ Warnings ~3 min read ▾

WARNINGS Bone Marrow Daunorubicin hydrochloride is a potent bone marrow suppressant. Suppression will occur in all patients given a therapeutic dose of this drug. Therapy with daunorubicin hydrochloride should not be started in patients with pre-existing drug-induced bone marrow suppression unless the benefit from such treatment warrants the risk.

Persistent, severe myelosuppression may result in superinfection or hemorrhage. Cardiac Effects Special attention must be given to the potential cardiac toxicity of daunorubicin hydrochloride, particularly in infants and children. Pre-existing heart disease and previous therapy with doxorubicin are co-factors of increased risk of daunorubicin-induced cardiac toxicity and the benefit-to-risk ratio of daunorubicin hydrochloride therapy in such patients should be weighed before starting daunorubicin hydrochloride.

In adults, at total cumulative doses less than 550 mg/m 2 , acute congestive heart failure is seldom encountered. However, rare instances of pericarditis-myocarditis, not dose-related, have been reported. In adults, at cumulative doses exceeding 550 mg/m 2 , there is an increased incidence of drug-induced congestive heart failure.

Based on prior clinical experience with doxorubicin, this limit appears lower, namely 400 mg/m 2 , in patients who received radiation therapy that encompassed the heart. In infants and children, there appears to be a greater susceptibility to anthracycline-induced cardiotoxicity compared to that in adults, which is more clearly dose-related. Anthracycline therapy (including daunorubicin) in pediatric patients has been reported to produce impaired left ventricular systolic performance, reduced contractility, congestive heart failure or death.

These conditions may occur months to years following cessation of chemotherapy. This appears to be dose-dependent and aggravated by thoracic irradiation. Long-term periodic evaluation of cardiac function in such patients should, thus, be performed.

In both children and adults, the total dose of daunorubicin hydrochloride administered should also take into account any previous or concomitant therapy with other potentially cardiotoxic agents or related compounds such as doxorubicin. There is no absolutely reliable method of predicting the patients in whom acute congestive heart failure will develop as a result of the cardiac toxic effect of daunorubicin hydrochloride. However, certain changes in the electrocardiogram and a decrease in the systolic ejection fraction from pre-treatment baseline may help to recognize those patients at greatest risk to develop congestive heart failure.

On the basis of the electrocardiogram, a decrease equal to or greater than 30% in limb lead QRS voltage has been associated with a significant risk of drug-induced cardiomyopathy. Therefore, an electrocardiogram and/or determination of systolic ejection fraction should be performed before each course of daunorubicin hydrochloride. In the event that one or the other of these predictive parameters should occur, the benefit of continued therapy must be weighed against the risk of producing cardiac damage.

Early clinical diagnosis of drug-induced congestive heart failure appears to be essential for successful treatment. Evaluation of Hepatic and Renal Function Significant hepatic or renal impairment can enhance the toxicity of the recommended doses of daunorubicin hydrochloride; therefore, prior to administration, evaluation of hepatic function and renal function using conventional clinical laboratory tests is recommended (see DOSAGE AND ADMINISTRATION section ). Pregnancy Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman.

An increased incidence of fetal abnormalities (parieto-occipital cranioschisis, umbilical hernias, or rachischisis) and abortions was reported in rabbits at doses of 0.05 mg/kg/day or approximately 1/100th of the highest recommended human dose on a body surface area basis. Rats showed an… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 107 words ▾

ADVERSE REACTIONS Dose-limiting toxicity includes myelosuppression and cardiotoxicity (see WARNINGS section). Other reactions include: Cutaneous Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely.

Gastrointestinal Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration.

Diarrhea and abdominal pain have occasionally been reported. Local If extravasation occurs during administration, severe local tissue necrosis, severe cellulitis, thrombophlebitis, or painful induration can result. Acute Reactions Rarely, anaphylactoid reaction, fever, and chills can occur.

Hyperuricemia may occur, especially in patients with leukemia, and serum uric acid levels should be monitored.

🔄 Drug Interactions 83 words ▾

Drug Interactions Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Daunorubicin hydrochloride should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride. Cyclophosphamide used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity.

Dosage reduction of daunorubicin hydrochloride may be required when used concurrently with other myelosuppressive agents. Hepatotoxic medications, such as high-dose methotrexate, may impair liver function and increase the risk of toxicity.

🤰 Pregnancy 147 words ▾

Pregnancy Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman. An increased incidence of fetal abnormalities (parieto-occipital cranioschisis, umbilical hernias, or rachischisis) and abortions was reported in rabbits at doses of 0.05 mg/kg/day or approximately 1/100th of the highest recommended human dose on a body surface area basis. Rats showed an increased incidence of esophageal, cardiovascular and urogenital abnormalities as well as rib fusions at doses of 4 mg/kg/day or approximately 1/2 the human dose on a body surface area basis.

Decreases in fetal birth weight and post-delivery growth rate were observed in mice. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Women of childbearing potential should be advised to avoid becoming pregnant.

🧒 Pediatric Use 47 words ▾

Pediatric Patients: Although appropriate studies with daunorubicin hydrochloride have not been performed in the pediatric population, cardiotoxicity may be more frequent and occur at lower cumulative doses in children.

Pediatric Use See CLINICAL PHARMACOLOGY , Special Populations , Pediatric Patients section and WARNINGS , Cardiac Effects section.

🧓 Geriatric Use 76 words ▾

Geriatric Patients: Although appropriate studies with daunorubicin hydrochloride have not been performed in the geriatric population, cardiotoxicity may be more frequent in the elderly. Caution should also be used in patients who have inadequate bone marrow reserves due to old age. In addition, elderly patients are more likely to have age-related renal function impairment, which may require reduction of dosage in patients receiving daunorubicin hydrochloride.

Elderly See CLINICAL PHARMACOLOGY , Special Populations , Geriatric Patients section.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action. Daunorubicin forms complexes with DNA by intercalation between base pairs. It inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes.

Single strand and double strand DNA breaks result. Daunorubicin hydrochloride may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Daunorubicin hydrochloride possesses an antitumor effect against a wide spectrum of animal tumors, either grafted or spontaneous.

Pharmacokinetics General: Following intravenous injection of daunorubicin hydrochloride, plasma levels of daunorubicin decline rapidly, indicating rapid tissue uptake and concentration. Thereafter, plasma levels decline slowly with a half-life of 45 minutes in the initial phase and 18.5 hours in the terminal phase. By 1 hour after drug administration, the predominant plasma species is daunorubicinol, an active metabolite, which disappears with a half-life of 26.7 hours.

Distribution: Daunorubicin hydrochloride is rapidly and widely distributed in tissues, with highest levels in the spleen, kidneys, liver, lungs, and heart. The drug binds to many cellular components, particularly nucleic acids. There is no evidence that daunorubicin crosses the blood-brain barrier, but the drug apparently crosses the placenta.

Metabolism and Elimination: Daunorubicin hydrochloride is extensively metabolized in the liver and other tissues, mainly by cytoplasmic aldo-keto reductases, producing daunorubicinol, the major metabolite which has antineoplastic activity. Approximately 40% of the drug in the plasma is present as daunorubicinol within 30 minutes and 60% in 4 hours after a dose of daunorubicin. Further metabolism via reduction cleavage of the glycosidic bond, 4-O demethylation, and conjugation with both sulfate and glucuronide have been demonstrated.

Simple glycosidic cleavage of daunorubicin or daunorubicinol is not a significant metabolic pathway in man. Twenty-five percent of an administered dose of daunorubicin hydrochloride is eliminated in an active form by urinary excretion and an estimated 40% by biliary excretion. Special Populations Pediatric Patients: Although appropriate studies with daunorubicin hydrochloride have not been performed in the pediatric population, cardiotoxicity may be more frequent and occur at lower cumulative doses in children.

Geriatric Patients: Although appropriate studies with daunorubicin hydrochloride have not been performed in the geriatric population, cardiotoxicity may be more frequent in the elderly. Caution should also be used in patients who have inadequate bone marrow reserves due to old age. In addition, elderly patients are more likely to have age-related renal function impairment, which may require reduction of dosage in patients receiving daunorubicin hydrochloride.

Renal and Hepatic Impairment: Doses of daunorubicin hydrochloride should be reduced in patients with hepatic and renal impairment. Patients with serum bilirubin concentrations of 1.2 to 3 mg/dL should receive 75% of the usual daily dose and patients with serum bilirubin concentrations greater than 3 mg/dL should receive 50% of the usual daily dose. Patients with serum creatinine concentrations of greater than 3 mg/dL should receive 50% of the usual daily dose.

(see WARNINGS , Evaluation of Hepatic and Renal Function ). Clinical Studies In the treatment of adult acute nonlymphocytic leukemia, daunorubicin hydrochloride, used as a single agent, has produced complete remission rates of 40 to 50%, and in combination with cytarabine, has produced complete remission rates of 53 to 65%. The addition of daunorubicin hydrochloride to the two-drug induction regimen of vincristine-prednisone in the treatment of childhood a… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 82 words ▾

HOW SUPPLIED DAUNOrubicin Hydrochloride Injection, 5 mg/mL, is available as a deep red sterile liquid in butyl-rubber-stoppered vials as follows: NDC 42658-021-01 20 mg, 4 mL per vial, single-dose vials; individually-boxed. NDC 42658-021-02 20 mg, 4 mL per vial, single-dose vials; individually-boxed and then carton of 10. NDC 42658-019-01 50 mg, 10 mL per vial, single-dose vial; individually-boxed.

To report SUSPECTED ADVERSE REACTION, contact Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-855-554-4786.

📋 Description 121 words ▾

DESCRIPTION Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus . It is provided as a deep red sterile liquid in vials for intravenous administration only. Each mL contains 5 mg daunorubicin (equivalent to 5.34 mg of daunorubicin hydrochloride), 9 mg sodium chloride; sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, q.s.

It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo -hexopyranoside hydrochloride. Its molecular formula is C 27 H 29 NO 10 •HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder.

The pH of a 5 mg/mL aqueous solution is 3 to 4. daunorubicin-hcl-media-id-001

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Therapy with daunorubicin hydrochloride requires close patient observation and frequent complete blood-count determinations. Cardiac, renal, and hepatic function should be evaluated prior to each course of treatment. Appropriate measures must be taken to control any systemic infection before beginning therapy with daunorubicin hydrochloride.

Daunorubicin hydrochloride may transiently impart a red coloration to the urine after administration, and patients should be advised to expect this. Laboratory Tests Daunorubicin hydrochloride may induce hyperuricemia secondary to rapid lysis of leukemic renal cells. As a precaution, allopurinol administration is usually begun prior to initiating antileukemic therapy.

Blood uric acid levels should be monitored and appropriate therapy initiated in the event that hyperuricemia develops. Carcinogenesis, Mutagenesis, Impairment of Fertility Daunorubicin hydrochloride, when injected subcutaneously into mice, causes fibrosarcomas to develop at the injection site. When administered to mice thrice weekly intraperitoneally, no carcinogenic effect was noted after 18 months of observation.

In male rats administered daunorubicin thrice weekly for 6 months, at 1/70th the recommended human dose on a body surface area basis, peritoneal sarcomas were found at 18 months. A single IV dose of daunorubicin administered to rats at 1.6 fold the recommended human dose on a body surface area basis caused mammary adenocarcinomas to appear at 1 year. Daunorubicin was mutagenic in vitro (Ames assay, V79 hamster cell assay), and clastogenic in vitro (CCRFCEM human lymphoblasts) and in vivo (SCE assay in mouse bone marrow) tests.

In male dogs at a daily dose of 0.25 mg/kg administered intravenously, testicular atrophy was noted at autopsy. Histologic examination revealed total aplasia of the spermatocyte series in the seminiferous tubules with complete aspermatogenesis. Pregnancy (See WARNINGS section) Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from daunorubicin, mothers should be advised to discontinue nursing during daunorubicin therapy. Elderly See CLINICAL PHARMACOLOGY , Special Populations , Geriatric Patients section. Pediatric Use See CLINICAL PHARMACOLOGY , Special Populations , Pediatric Patients section and WARNINGS , Cardiac Effects section.

Drug Interactions Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Daunorubicin hydrochloride should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride. Cyclophosphamide used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity.

Dosage reduction of daunorubicin hydrochloride may be required when used concurrently with other myelosuppressive agents. Hepatotoxic medications, such as high-dose methotrexate, may impair liver function and increase the risk of toxicity.

🍼 Nursing Mothers 46 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from daunorubicin, mothers should be advised to discontinue nursing during daunorubicin therapy.

🔬 Clinical Studies 202 words ▾

Clinical Studies In the treatment of adult acute nonlymphocytic leukemia, daunorubicin hydrochloride, used as a single agent, has produced complete remission rates of 40 to 50%, and in combination with cytarabine, has produced complete remission rates of 53 to 65%. The addition of daunorubicin hydrochloride to the two-drug induction regimen of vincristine-prednisone in the treatment of childhood acute lymphocytic leukemia does not increase the rate of complete remission. In children receiving identical CNS prophylaxis and maintenance therapy (without consolidation), there is prolongation of complete remission duration (statistically significant, p<0.02) in those children induced with the three drug (daunorubicin-vincristine-prednisone) regimen as compared to two drugs.

There is no evidence of any impact of daunorubicin hydrochloride on the duration of complete remission when a consolidation (intensification) phase is employed as part of a total treatment program. In adult acute lymphocytic leukemia, in contrast to childhood acute lymphocytic leukemia, daunorubicin hydrochloride during induction significantly increases the rate of complete remission, but not remission duration, compared to that obtained with vincristine, prednisone, and L-asparaginase alone. The use of daunorubicin hydrochloride in combination with vincristine, prednisone, and L-asparaginase has produced complete remission rates of 83% in contrast to a 47% remission in patients not receiving daunorubicin hydrochloride.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 158 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Daunorubicin hydrochloride, when injected subcutaneously into mice, causes fibrosarcomas to develop at the injection site. When administered to mice thrice weekly intraperitoneally, no carcinogenic effect was noted after 18 months of observation. In male rats administered daunorubicin thrice weekly for 6 months, at 1/70th the recommended human dose on a body surface area basis, peritoneal sarcomas were found at 18 months.

A single IV dose of daunorubicin administered to rats at 1.6 fold the recommended human dose on a body surface area basis caused mammary adenocarcinomas to appear at 1 year. Daunorubicin was mutagenic in vitro (Ames assay, V79 hamster cell assay), and clastogenic in vitro (CCRFCEM human lymphoblasts) and in vivo (SCE assay in mouse bone marrow) tests. In male dogs at a daily dose of 0.25 mg/kg administered intravenously, testicular atrophy was noted at autopsy.

Histologic examination revealed total aplasia of the spermatocyte series in the seminiferous tubules with complete aspermatogenesis.

📚 References 175 words ▾

REFERENCES Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621.

For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA , March 15,1985.

National Study Commission on Cytotoxic Exposure Recommendations for Handling Cytotoxic Agents. Available from Louis R Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents.

Med J Australia 1:426-428, 1983. Jones RB, et al: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center, Ca A Cancer Journal for Clinicians Sept/Oct, 258-263, 1983. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs.

Am J Hosp Pharm 47:1033-1049, 1990. OSHA Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm 43:1193-1204, 1986.

Distributed by: Hisun Pharmaceuticals USA, Inc. Bridgewater, NJ 08807 USA Manufactured in China Issued: 08/2020

📄 Package Label / Principal Display Panel 5 words ▾

daunorubicin-hcl-media-id-002 daunorubicin-hcl-media-id-003 daunorubicin-hcl-media-id-006 daunorubicin-hcl-media-id-004 daunorubicin-hcl-media-id-005

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 vial42658-0021-01 55 Rx · $17,445
10 vials42658-0021-02 No Medicaid data
1 vial42658-0021-91 No Medicaid data
10 vials this page42658-0021-92 No Medicaid data
Drug total (last 4 qtrs): 55 Rx · 438 units · $17,445 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Daunorubicin Hydrochloride — the ingredient across all brands.

Top reported reactions

Febrile Neutropenia194
Myelosuppression161
Bacterial Infection154
Secondary Immunodeficiency130
Pyrexia122
Clostridium Difficile Colitis110
Pancytopenia92

Age at onset

Neonate1
Infant22
Child65
Adolescent14
Adult79
Elderly18

Reporter sex

1,580 reports
Male · 52%
Female · 48%
Unknown · 0%

Serious outcomes

Hospitalization729
Death394
Life-threatening252
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 205 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Hisun Pharmaceuticals USA, Inc.. 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 3 other package presentations of this same product, including 1 vial (42658-0021-01), 1 vial (42658-0021-91), 10 vials (42658-0021-02). 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?
Hisun Pharmaceuticals USA, Inc. 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 J9150 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.
← 42658-0019-01 · Hisun 42658-0022-01 · Hisun →
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.