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Dexrazoxane 500 mg Injection, Powder, Lyophilized, For Solution — NDC 00143-9248-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dexrazoxane 500 mg Injection, Powder, Lyophilized, For Solution — NDC 0143-9248-01 (Billing 00143-9248-01)

by Hikma Pharmaceuticals USA Inc. · 1 VIAL in 1 BOX / 50 mL in 1 VIAL

This is a package of Dexrazoxane 500 mg Injection, Powder, Lyophilized, For Solution from Hikma Pharmaceuticals USA Inc., marketed since Mar 2005 and currently FDA-listed. It is this product's only package size.

NDC 00143-9248-01
🏷️ FDA NDC (as labeled) 0143-9248-01 billing pads the labeler segment with a zero
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 →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0143-9248-01
Product NDC 0143-9248
11-digit billing NDC 00143924801
NCPDP billing unit EA — each (per item)
RxCUI 1736585, 1736590
UNII 5346058Q7S
Application # ANDA076068
SPL Set ID 68089182-d4a2-4053-8d0d-fc97a901515d
Established class (EPC) Cytoprotective Agent
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-03-31
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance DEXRAZOXANE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 21754040102140
GPI class Dexrazoxane HCl
GCN Seq No 036426
GCN 95873
HICL code 016635
Ingredient (HICL) Dexrazoxane Hcl
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1I
Therapeutic class — specific (HIC3) Chemotherapy Rescue/Antidote Agents
AHFS code 91:04.12.00
AHFS class Chemotherapy Antidotes/Protectants
FDB label name DEXRAZOXANE 500 MG VIAL
FDB brand name Dexrazoxane
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 036426
  • GCN: 95873
  • GPI-14 (Medi-Span): 21754040102140
  • HICL (First Databank): 016635
  • AHFS class code: 91:04.12.00
  • RxCUI (RxNorm): 1736585
Why two NDCs? The FDA registers this code as 0143-9248-01 — a 4-4-2 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 labeler segment → 00143-9248-01. 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 Cytoprotective Agent class.

Pharmacologic class Cytoprotective Agent
Drug family (ATC) Detoxifying agents for antineoplastic treatment
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 DEXRAZOXANE 500 MG VIAL Ingredient Dexrazoxane Hcl
📖 What it is MedlinePlus · NLM

Dexrazoxane injection (Totect, Zinecard) is used to prevent or decrease thickening of the heart muscles caused by doxorubicin in women who are taking the medication to treat breast cancer that has spread to other parts of the body. Dexrazoxane injection (Totect, Zinecard) is only given to women who have already received a certain amount of doxorubicin and who will need continued doxorubicin treatment, it is not used to prevent heart damage in women who are starting treatment with doxorubicin. Dexrazoxane injection (Totect) is used to decrease damage to the skin and tissues that may be caused w...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps protect your heart from damage caused by doxorubicin. It is used in women with metastatic breast cancer who have already received a certain amount of doxorubicin and are c...
  • A healthcare professional gives it through an IV over about 15 minutes. It is given before your doxorubicin, never after. Your team decides the dose and may lower it if your kidney...
  • Since you'll also be on chemotherapy, effects like hair loss, nausea, vomiting, tiredness and mouth sores are common. Pain at the injection site was more common with this drug. Let...
  • Call if you have fever, chills or signs of infection, unusual bruising or bleeding, or new heart symptoms like shortness of breath or swelling. Your blood counts can drop lower wit...
📖 Read our full Dexrazoxane Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 · J1190 $41.441 / J1190 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)0143-9248-01
11-digit billing NDC00143-9248-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1190
DescriptorINJECTION, DEXRAZOXANE HYDROCHLORIDE, PER 250 MG
Billing units / pkg2 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 250 MG, so one package = 2 billing units.
Medicare Part B spend (2026 (Q1))$142,304 · 567 claims · $250.98 per claim (all NDCs under J1190)
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
00143-9248-01 You're viewing this Main listing 1 VIAL in 1 BOX / 50 mL in 1 VIAL 2017-10-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dexrazoxane 500 mgthis 00143-9248-01 Hikma 1 vial — AP FDA listed —
Dexrazoxane 55150-0437-01 Eugia 1 kit — AP FDA listed —
Dexrazoxane 500 mg/50mL 68083-0195-01 Gland 1 vial — AP FDA listed —
Dexrazoxane 500 mg/50mL 72205-0248-01 Novadoz 1 vial — AP FDA listed —
Dexrazoxane 500 mg/50mL 72266-0101-01 Fosun 1 vial — AP FDA listed —
Dexrazoxane 500 mg/50mL 72611-0716-01 Almaject, 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

🏛️
2005
On the market since
Mar 2005
📍
2026
Currently FDA-listed
21 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.

💡 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.

1 inactive ingredient 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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA076068 (ANDA)
Labeler code00143
First marketedMar 2005
Product typeHuman Prescription Drug
Portfolio726 products on file
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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 125 words ▾

1 INDICATIONS AND USAGE Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2 )] . Dexrazoxane for injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control.

Do not use dexrazoxane for injection with doxorubicin initiation. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Reconstitute vial contents and dilute before use. (2.3) Administer Dexrazoxane for injection by intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH.

( 2.1 , 2.3 ) The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. ( 2.1 ) Reduce dose by 50% for patients with creatinine clearance <40 mL/min.

( 2.2 , 8.7 )

2.1Recommended Dose Administer dexrazoxane for injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. Administer doxorubicin within 30 minutes after the completion of dexrazoxane for injection infusion.

2.2Dose Modifications Dosing in Patients with Renal Impairment Reduce dexrazoxane for injection dosage in patients with moderate to severe renal impairment (creatinine clearance values less than 40 mL/min) by 50% (dexrazoxane for injection to doxorubicin ratio reduced to 5:1; such as 250 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin) [see Use in Specific Populations (8.6 ) and Clinical Pharmacology (12.3 )] . Dosing in Patients with Hepatic Impairment Since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia, reduce the dexrazoxane for injection dosage proportionately (maintaining the 10:1 ratio) in patients with hepatic impairment.

2.3Preparation and Administration Preparation and Handling of Infusion Solution Reconstitute dexrazoxane for injection with Sterile Water for Injection, USP. Reconstitute with 25 mL for a dexrazoxane for injection 250 mg vial and 50 mL for a dexrazoxane for injection 500 mg vial to give a concentration of 10 mg/mL. Dilute the reconstituted solution further with Lactated Ringer’s Injection, USP to a concentration of 1.3 to 3.0 mg/mL in intravenous infusion bags for intravenous infusion.

Following reconstitution with Sterile Water for Injection, USP, dexrazoxane for injection is stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2° to 8°C (36° to 46°F). The pH of the resultant solution is 1.0 to 3.0. DISCARD UNUSED SOLUTIONS.

The diluted infusion solutions are stable for one hour at room temperature or if storage is necessary, up to 4 hours when stored under refrigeration, 2° to 8°C (36° to 46°F). The infusion solutions have a pH of 3.5 to 5.5. DISCARD UNUSED SOLUTIONS.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Solutions containing a precipitate should be discarded. Use caution when handling and preparing the reconstituted solution.

The use of gloves is recommended. If dexrazoxane for injection powder or solutions contact the skin or mucosae, wash exposed area immediately and thoroughly with soap and water. Follow special handling and disposal procedures.

1 Administration Do not mix dexrazoxane for injection with other drugs. Administer the final diluted solution of dexrazoxane for injection by intravenous infusion over 15 minutes before the administration of doxorubicin. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH.

Administer doxorubicin within 30 minutes after the completion of dexrazoxane for injection infusion.

2.1Recommended Dose Administer dexrazoxane for injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. Administer… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Dexrazoxane for injection (dexrazoxane for injection) is available in 250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates. 250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates. (3)

⛔ Contraindications 24 words ▾

4 CONTRAINDICATIONS Do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. Dexrazoxane for injection should not be used with non-anthracycline chemotherapy regimens. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Myelosuppression: Dexrazoxane for injection may increase the myelosuppresive effects of chemotherapeutic agents. Perform hematological monitoring. (5.1) Embryo-Fetal Toxicity: Can cause fetal harm. Advise female patients of reproductive potential of the potential hazard to the fetus. ( 5.5 , 8.1 )

5.1Myelosuppression Dexrazoxane for injection may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer dexrazoxane for injection and chemotherapy only when adequate hematologic parameters are met.

5.2Concomitant Chemotherapy Only use dexrazoxane for injection in those patients who have received a cumulative doxorubicin dose of 300 mg/m 2 and are continuing with doxorubicin therapy. Do not use with chemotherapy initiation as dexrazoxane for injection may interfere with the antitumor activity of the chemotherapy regimen. In a trial conducted in patients with metastatic breast cancer who were treated with fluorouracil, doxorubicin, and cyclophosphamide (FAC) with or without dexrazoxane for injection starting with their first cycle of FAC therapy, patients who were randomized to receive dexrazoxane for injection had a lower response rate (48% vs.

63%) and shorter time to progression than patients who were randomized to receive placebo.

5.3Cardiac Toxicity Treatment with dexrazoxane for injection does not completely eliminate the risk of anthracycline-induced cardiac toxicity. Monitor cardiac function before and periodically during therapy to assess left ventricular ejection fraction (LVEF). In general, if test results indicate deterioration in cardiac function associated with doxorubicin, the benefit of continued therapy should be carefully evaluated against the risk of producing irreversible cardiac damage.

5.4Secondary Malignancies Secondary malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) have been reported in studies of pediatric patients who have received dexrazoxane for injection in combination with chemotherapy. Dexrazoxane for injection is not indicated for use in pediatric patients. Some adult patients who received dexrazoxane for injection in combination with anti-cancer agents known to be carcinogenic have also developed secondary malignancies, including AML and MDS.

Razoxane is the racemic mixture, of which dexrazoxane is the S(+)-enantiomer. Secondary malignancies (primarily acute myeloid leukemia) have been reported in patients treated chronically with oral razoxane. In these patients, the total cumulative dose of razoxane ranged from 26 to 480 grams and the duration of treatment was from 42 to 319 weeks.

One case of T- cell lymphoma, one case of B-cell lymphoma, and six to eight cases of cutaneous basal cell or squamous cell carcinoma have also been reported in patients treated with razoxane. Long-term administration of razoxane to rodents was associated with the development of malignancies [see Nonclinical Toxicology (13.1 )] .

5.5Embryo-Fetal Toxicity Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration during the period of organogenesis resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose [see Use in Specific Populations (8.1)] . 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 a fetus.

Advise female patients of reproductive potential to avoid becoming pregnant and to use highly effective contraception during treatment [see Use in Specific Populations (8.6 )] .

5.1Myelosuppression Dexrazoxane for injection may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer dexrazoxane for injection and chemoth… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS In clinical studies, dexrazoxane for injection was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving dexrazoxane for injection versus placebo. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The adverse reaction profile described in this section was identified from randomized, placebo- controlled, double-blind studies in patients with metastatic breast cancer who received the combination of the FAC chemotherapy regimen with or without dexrazoxane for injection.

The dose of doxorubicin was 50 mg/m 2 in each of these trials. Treatment was administered every three weeks until disease progression or cardiac toxicity. Patients in clinical trials who received FAC with dexrazoxane for injection experienced more severe leukopenia, granulocytopenia, and thrombocytopenia than patients receiving FAC without dexrazoxane for injection [see Warnings and Precautions (5.1 )] .

Table 1 below lists the incidence of adverse reactions for patients receiving FAC with either dexrazoxane for injection or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving dexrazoxane for injection or placebo with FAC beginning with their first course of therapy (columns 1 and 3, respectively). Adverse experiences occurring at course 7 and beyond for patients who received placebo with FAC during the first six courses and who then received either dexrazoxane for injection or placebo with FAC are also displayed (columns 2 and 4, respectively).

The adverse reactions listed below in Table 1 demonstrate that the frequency of adverse reaction “Pain on Injection” has been greater for dexrazoxane for injection arm, as compared to placebo. Table 1 Adverse Reaction Percentage (%) of Breast Cancer Patients With Adverse Reaction FAC + Dexrazoxane FAC + Placebo Courses 1 to 6 N = 413 Courses ≥ 7 N = 102 Courses 1 to 6 N = 458 Courses ≥ 7 N = 99 Alopecia 94 100 97 98 Nausea 77 51 84 60 Vomiting 59 42 72 49 Fatigue/Malaise 61 48 58 55 Anorexia 42 27 47 38 Stomatitis 34 26 41 28 Fever 34 22 29 18 Infection 23 19 18 21 Diarrhea 21 14 24 7 Pain on Injection 12 13 3 0 Sepsis 17 12 14 9 Neurotoxicity 17 10 13 5 Streaking/Erythema 5 4 4 2 Phlebitis 6 3 3 5 Esophagitis 6 3 7 4 Dysphagia 8 0 10 5 Hemorrhage 2 3 2 1 Extravasation 1 3 1 2 Urticaria 2 2 2 0 Recall Skin Reaction 1 1 2 0

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. The adverse reaction profile described in this section was identified from randomized, placebo- controlled, double-blind studies in patients with metastatic breast cancer who received the combination of the FAC chemotherapy regimen with or without dexrazoxane for injection.

The dose of doxorubicin was 50 mg/m 2 in each of these trials. Treatment was administered every three weeks until disease progression or cardiac toxicity. Patients in clinical trials who received FAC with dexrazoxane for injection experienced more severe leukopenia, granulocytopenia, and thrombocytopenia than patients receiving FAC without dexrazoxane for injection [see Warnings and Precautions (5.1 )] .

Table 1 below lists the incidence of adverse reactions for patients receiving FAC with either dexrazoxane for injection or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiv… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 15 words ▾

7 DRUG INTERACTIONS No drug interactions have been identified [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Discontinue drug or nursing. (8.3)

8.1Pregnancy Teratogenic Effects. Pregnancy Category D Risk Summary Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose.

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 a fetus [see Warnings and Precautions (5.5)] . Animal Data Dexrazoxane resulted in maternal toxicity in rats at doses of ≥2 mg/kg (1/40 the human dose on a mg/m 2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) when given daily to pregnant rats during the period of organogenesis. Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia.

In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of ≥5 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m 2 basis) were embryotoxic and teratogenic. Teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung.

8.3Nursing Mothers It is not known whether dexrazoxane or its metabolites are 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 dexrazoxane, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use The safety and effectiveness of dexrazoxane in pediatric patients have not been established [see Warnings and Precautions (5.4)] .

8.5Geriatric Use Clinical studies of dexrazoxane for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6Females of Reproductive Potential Contraception Dexrazoxane for injection can cause fetal harm when administered during pregnancy. Advise female patients of reproductive potential to use highly effective contraception during treatment [see Use in Specific Populations (8.1 )] .

8.7Renal Impairment Greater exposure to dexrazoxane may occur in patients with compromised renal function. Reduce the dexrazoxane for injection dose by 50% in patients with creatinine clearance values <40 mL/min [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3 )] .

8.6Females of Reproductive Potential Contraception Dexrazoxane for injection can cause fetal harm when administered during pregnancy. Advise female patients of reproductive potential to use highly effective contraception during treatment [see Use in Specific Populations (8.1 )] .

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Teratogenic Effects. Pregnancy Category D Risk Summary Dexrazoxane for injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose.

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 a fetus [see Warnings and Precautions (5.5)] . Animal Data Dexrazoxane resulted in maternal toxicity in rats at doses of ≥2 mg/kg (1/40 the human dose on a mg/m 2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) when given daily to pregnant rats during the period of organogenesis. Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia.

In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of ≥5 mg/kg (approximately 1/10 the human dose on a mg/m 2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m 2 basis) were embryotoxic and teratogenic. Teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung.

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use The safety and effectiveness of dexrazoxane in pediatric patients have not been established [see Warnings and Precautions (5.4)] .

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use Clinical studies of dexrazoxane for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 131 words ▾

10 OVERDOSAGE There are no data on overdosage in the cardioprotective trials; the maximum dose administered during the cardioprotective trials was 1000 mg/m 2 every three weeks. Disposition studies with dexrazoxane for injection have not been conducted in cancer patients undergoing dialysis, but retention of a significant dose fraction (>0.4) of the unchanged drug in the plasma pool, minimal tissue partitioning or binding, and availability of greater than 90% of the systemic drug levels in the unbound form suggest that it could be removed using conventional peritoneal or hemodialysis.

There is no known antidote for dexrazoxane. Instances of suspected overdose should be managed with good supportive care until resolution of myelosuppression and related conditions is complete. Management of overdose should include treatment of infections, fluid regulation, and maintenance of nutritional requirements.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which dexrazoxane for injection exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part, for anthracycline-induced cardiomyopathy.

12.3Pharmacokinetics The pharmacokinetics of dexrazoxane have been studied in advanced cancer patients with normal renal and hepatic function. The pharmacokinetics of dexrazoxane can be adequately described by a two-compartment open model with first-order elimination. Dexrazoxane has been administered as a 15 minute infusion over a dose range of 60 to 900 mg/m 2 with 60 mg/m 2 of doxorubicin, and at a fixed dose of 500 mg/m 2 with 50 mg/m 2 doxorubicin.

The disposition kinetics of dexrazoxane are dose-independent, as shown by linear relationship between the area under plasma concentration-time curves and administered doses ranging from 60 to 900 mg/m 2 . The mean peak plasma concentration of dexrazoxane was 36.5 mcg/mL at 15- minute after intravenous administration of 500 mg/m 2 dose of dexrazoxane for injection over 15 to 30 minutes prior to the 50 mg/m 2 doxorubicin dose. The important pharmacokinetic parameters of dexrazoxane are summarized in Table 2: Table 2: SUMMARY OF MEAN (%CV a ) DEXRAZOXANE PHARMACOKINETIC PARAMETERS AT A DOSAGE RATIO OF 10:1 OF DEXRAZOXANE FOR INJECTION:DOXORUBICIN Dose Dose Number of Elimination Plasma Renal bVolume of Doxorubicin (mg/m2) Dexrazoxane (mg/m2) Subjects Half-Life (h) Clearance (L/h/m2) Clearance (L/h/m2) Distribution (L/m2) 50 500 10 2.5 (16) 7.88 (18) 3.35 (36) 22.4 (22) 60 600 5 2.1 (29) 6.25 (31) — 22.0 (55) a Coefficient of variation b Steady-state volume of distribution Distribution Following a rapid distributive phase (0.2 to 0.3 hours), dexrazoxane reaches post-distributive equilibrium within two to four hours.

The estimated mean steady-state volume of distribution of dexrazoxane is

22.4L/m 2 after 500 mg/m 2 of dexrazoxane for injection dose followed by 50 mg/m 2 of doxorubicin, suggesting distribution throughout total body water (25 L/m 2 ). In vitro studies have shown that dexrazoxane is not bound to plasma proteins. Metabolism Qualitative metabolism studies with dexrazoxane have confirmed the presence of unchanged drug, a diacid-diamide cleavage product, and two monoacid-monoamide ring products in the urine of animals and man.

The metabolite levels were not measured in the pharmacokinetic studies. Excretion Urinary excretion plays an important role in the elimination of dexrazoxane. Forty-two percent of a 500 mg/m 2 dose of dexrazoxane for injection was excreted in the urine.

Renal clearance averages

3.35L/h/m 2 after the 500 mg/m 2 dexrazoxane for injection dose followed by 50 mg/m 2 of doxorubicin. Specific Populations Pediatric Pharmacokinetics following dexrazoxane for injection administration have not been evaluated in pediatric patients. Effect of Renal Impairment The pharmacokinetics of dexrazoxane were assessed following a single 15-minute IV infusion of 150 mg/m 2 of dexrazoxane for injection.

Dexrazoxane clearance was reduced in subjects with renal dysfunction. Compared with controls, the mean AUC 0-inf value was two-fold greater in subjects with moderate (CL CR 30-50 mL/min) to severe (CL CR <30 mL/min) renal dysfunction. Modeling demonstrated that equivalent exposure (AUC -inf ) could be achieved if dosing were reduced by 50% in subjects with creatinine clearance values <40 mL/min compared with control subjects (CL CR >80 mL/min) [see Use in Specific Populations (8.7) and Dosage and Administration (2.2 )] .

Effect of Hepatic Impairment Pharmacokinetics following dexrazoxane for injection administration have not been evaluated in patients with hepatic impairment. The dexrazoxane fo… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 61 words ▾

12.1Mechanism of Action The mechanism by which dexrazoxane for injection exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part, for anthracycline-induced cardiomyopathy.

📦 How Supplied / Storage and Handling 71 words ▾

16 HOW SUPPLIED Dexrazoxane for Injection is available in the following strengths as sterile, pyrogen-free lyophilizates. NDC 0143-9247-01 250 mg single dose vial with a gray flip-top seal, packaged in single vial packs. NDC 0143-9248-01 500 mg single dose vial with a blue flip-top seal, packaged in single vial packs. Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature]. Follow special handling and disposal procedures. 1

📋 Description ~1 min read ▾

11 DESCRIPTION Dexrazoxane for Injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (+)-( S )-4,4’-Propylenedi-2,6-piperazinedione. The structural formula is as follows: Structural Formula C 11 H 16 N 4 O 4 M.W.

268.27 Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and

0.1N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pK a is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0.

Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane.

The pH of the resultant solution is 1.0 to 3.0. Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment.

When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0. The reconstituted dexrazoxane for injection solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer’s Injection, USP, for rapid intravenous drip infusion.

DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH [see Dosage and Administration (2.1 , 2.3)] . Structural Formula

💬 Information for Patients 102 words ▾

17 PATIENT COUNSELING INFORMATION

17.1Myelosuppression Treatment with dexrazoxane for injection is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring [see Warnings and Precautions ( 5.1 )] .

17.2Embryo-Fetal Toxicity Counsel patients on pregnancy planning and prevention. Advise female patients of reproductive potential that dexrazoxane for injection can cause fetal harm and to use highly effective contraception during treatment [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.1 , 8.6)] . Manufactured By: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany Distributed by: Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922 Revised March 2020 127.207.025/01

🍼 Nursing Mothers 63 words ▾

8.3Nursing Mothers It is not known whether dexrazoxane or its metabolites are 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 dexrazoxane, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of dexrazoxane have been studied in advanced cancer patients with normal renal and hepatic function. The pharmacokinetics of dexrazoxane can be adequately described by a two-compartment open model with first-order elimination. Dexrazoxane has been administered as a 15 minute infusion over a dose range of 60 to 900 mg/m 2 with 60 mg/m 2 of doxorubicin, and at a fixed dose of 500 mg/m 2 with 50 mg/m 2 doxorubicin.

The disposition kinetics of dexrazoxane are dose-independent, as shown by linear relationship between the area under plasma concentration-time curves and administered doses ranging from 60 to 900 mg/m 2 . The mean peak plasma concentration of dexrazoxane was 36.5 mcg/mL at 15- minute after intravenous administration of 500 mg/m 2 dose of dexrazoxane for injection over 15 to 30 minutes prior to the 50 mg/m 2 doxorubicin dose. The important pharmacokinetic parameters of dexrazoxane are summarized in Table 2: Table 2: SUMMARY OF MEAN (%CV a ) DEXRAZOXANE PHARMACOKINETIC PARAMETERS AT A DOSAGE RATIO OF 10:1 OF DEXRAZOXANE FOR INJECTION:DOXORUBICIN Dose Dose Number of Elimination Plasma Renal bVolume of Doxorubicin (mg/m2) Dexrazoxane (mg/m2) Subjects Half-Life (h) Clearance (L/h/m2) Clearance (L/h/m2) Distribution (L/m2) 50 500 10 2.5 (16) 7.88 (18) 3.35 (36) 22.4 (22) 60 600 5 2.1 (29) 6.25 (31) — 22.0 (55) a Coefficient of variation b Steady-state volume of distribution Distribution Following a rapid distributive phase (0.2 to 0.3 hours), dexrazoxane reaches post-distributive equilibrium within two to four hours.

The estimated mean steady-state volume of distribution of dexrazoxane is

22.4L/m 2 after 500 mg/m 2 of dexrazoxane for injection dose followed by 50 mg/m 2 of doxorubicin, suggesting distribution throughout total body water (25 L/m 2 ). In vitro studies have shown that dexrazoxane is not bound to plasma proteins. Metabolism Qualitative metabolism studies with dexrazoxane have confirmed the presence of unchanged drug, a diacid-diamide cleavage product, and two monoacid-monoamide ring products in the urine of animals and man.

The metabolite levels were not measured in the pharmacokinetic studies. Excretion Urinary excretion plays an important role in the elimination of dexrazoxane. Forty-two percent of a 500 mg/m 2 dose of dexrazoxane for injection was excreted in the urine.

Renal clearance averages

3.35L/h/m 2 after the 500 mg/m 2 dexrazoxane for injection dose followed by 50 mg/m 2 of doxorubicin. Specific Populations Pediatric Pharmacokinetics following dexrazoxane for injection administration have not been evaluated in pediatric patients. Effect of Renal Impairment The pharmacokinetics of dexrazoxane were assessed following a single 15-minute IV infusion of 150 mg/m 2 of dexrazoxane for injection.

Dexrazoxane clearance was reduced in subjects with renal dysfunction. Compared with controls, the mean AUC 0-inf value was two-fold greater in subjects with moderate (CL CR 30-50 mL/min) to severe (CL CR <30 mL/min) renal dysfunction. Modeling demonstrated that equivalent exposure (AUC -inf ) could be achieved if dosing were reduced by 50% in subjects with creatinine clearance values <40 mL/min compared with control subjects (CL CR >80 mL/min) [see Use in Specific Populations (8.7) and Dosage and Administration (2.2 )] .

Effect of Hepatic Impairment Pharmacokinetics following dexrazoxane for injection administration have not been evaluated in patients with hepatic impairment. The dexrazoxane for injection dose is dependent upon the dose of doxorubicin [see Dosage and Administration (2.2)] . Drug Interactions There was no significant change in the pharmacokinetics of doxorubicin (50 mg/m 2 ) and its predominant metabolite, doxorubicinol, in the presence of dexrazoxane (500 mg/m 2 ) in a crossover study in cancer patients.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The ability of dexrazoxane for injection to prevent/reduce the incidence and severity of doxorubicin-induced cardiomyopathy was evaluated in three prospectively randomized placebo-controlled studies. In these studies, patients were treated with a doxorubicin-containing regimen and either dexrazoxane for injection or placebo starting with the first course of chemotherapy. There was no restriction on the cumulative dose of doxorubicin.

Cardiac function was assessed by measurement of the LVEF, utilizing resting multigated nuclear medicine (MUGA) scans, and by clinical evaluations. Patients receiving dexrazoxane for injection had significantly smaller mean decreases from baseline in LVEF and lower incidences of congestive heart failure than the control group; however, in the largest study, patients with advanced breast cancer receiving FAC with dexrazoxane for injection had a lower response rate (48% vs. 63%) and a shorter time to progression than patients who received FAC versus placebo.

In the clinical trials, patients who were initially randomized to receive placebo were allowed to receive dexrazoxane for injection after a cumulative dose of doxorubicin above 300 mg/m 2 . Retrospective historical analyses showed that the risk of experiencing a cardiac event (see Table 3 for definition) at a cumulative dose of doxorubicin above 300 mg/m 2 was greater in the patients who did not receive dexrazoxane for injection beginning with their seventh course of FAC than in the patients who did receive dexrazoxane for injection (HR=13.08; 95% CI: 3.72, 46.03; p<0.001).

Overall, 3% of patients treated with dexrazoxane for injection developed CHF compared with 22% of patients not receiving dexrazoxane for injection. Table 3: Definition of Cardiac Events: Development of congestive heart failure, defined as having two or more of the following: Cardiomegaly by X-ray Basilar Rales S3 Gallop Paroxysmal nocturnal dyspnea and/or orthopnea and/or significant dyspnea on exertion. Decline from baseline in LVEF by ≥10% and to below the lower limit of normal for the institution.

Decline in LVEF by ≥20% from baseline value. Decline in LVEF to ≥5% below lower limit of normal for the institution. Figure 1 shows the number of patients still on treatment at increasing cumulative doses.

Figure 1 Cumulative Number of Patients On Treatment FAC vs. FAC/Dexrazoxane for Injection Patients Patients Receiving at Least Seven Courses of Treatment Figure 1 Figure 1

🧪 Nonclinical Toxicology 171 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis and Mutagenesis and Impairment of Fertility No long-term carcinogenicity studies have been carried out with dexrazoxane in animals. Nevertheless, a study by the National Cancer Institute has reported that long-term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice [see Warnings and Precautions (5.4 )] . Dexrazoxane was not mutagenic in the bacterial reverse mutation (Ames) test, but was found to be clastogenic to human lymphocytes in vitro and to mouse bone marrow erythrocytes in vivo (micronucleus test).

Dexrazoxane for injection has the potential to impair fertility in male patients based on effects in repeat-dose toxicology studies. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (1/3 the human dose on a mg/m 2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (approximately equal to the human dose on a mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 168 words ▾

13.1Carcinogenesis and Mutagenesis and Impairment of Fertility No long-term carcinogenicity studies have been carried out with dexrazoxane in animals. Nevertheless, a study by the National Cancer Institute has reported that long-term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice [see Warnings and Precautions (5.4 )] . Dexrazoxane was not mutagenic in the bacterial reverse mutation (Ames) test, but was found to be clastogenic to human lymphocytes in vitro and to mouse bone marrow erythrocytes in vivo (micronucleus test).

Dexrazoxane for injection has the potential to impair fertility in male patients based on effects in repeat-dose toxicology studies. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (1/3 the human dose on a mg/m 2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (approximately equal to the human dose on a mg/m 2 basis).

📚 References 8 words ▾

15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA http://www.osha.gov/SLTC/hazardousdrugs/index.html.

📄 Package Label / Principal Display Panel 102 words ▾

Vial Label 250 mg NDC 0143-9247-01 Rx only Dexrazoxane for Injection 250 mg per vial For Intravenous use ONLY STERILE, PYROGEN-FREE, LYOPHILIZATE Single Dose Vial vial

Carton 250 mg NDC 0143-9247-01 Rx only Dexrazoxane for Injection 250 mg per vial For Intravenous use ONLY STERILE, PYROGEN-FREE, LYOPHILIZATE Single Dose Vial carton

Vial Label 500 mg NDC 0143-9248-01 Rx only Dexrazoxane for Injection 500 mg per vial For Intravenous use ONLY STERILE, PYROGEN-FREE, LYOPHILIZATE Single Dose Vial vial

Carton 500 mg NDC 0143-9248-01 Rx only Dexrazoxane for Injection 500 mg per vial For Intravenous use ONLY STERILE, PYROGEN-FREE, LYOPHILIZATE Single Dose Vial carton

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

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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?
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