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Etopophos etoposide phosphate 100 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 61269-0410-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Etopophos etoposide phosphate 100 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 61269-410-20 (Billing 61269-0410-20)

by H2-Pharma, LLC · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of Etopophos etoposide phosphate 100 mg Injection, Powder, Lyophilized, For Solution from H2-Pharma, LLC, marketed since Jun 2009 and currently FDA-listed. It is this product's only package size.

NDC 61269-0410-20
🏷️ FDA NDC (as labeled) 61269-410-20 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 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

NDC database record

One package, one record: these facts belong to NDC 61269-410-20 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61269 labeler · 410 product · 20 package
Package marketed since
Jun 1, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 6126941020 8
Medicaid fills, this package
178 prescriptions in the last four reported quarters
FDA record last changed
Sep 17, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61269-410-20
Product NDC 61269-410
11-digit billing NDC 61269041020
NCPDP billing unit EA — each (per item)
RxCUI 226719, 1734340
UNII 528XYJ8L1N
Application # NDA020457
SPL Set ID 7499fc35-fae8-44ad-bbab-9a1a589bf3ee
Established class (EPC) Topoisomerase Inhibitor
Mechanism of action Topoisomerase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-06-01
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ETOPOSIDE PHOSPHATE

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

GCN Seq No 027350
GCN 07552
HICL code 011549
Ingredient (HICL) Etoposide Phosphate
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1F
Therapeutic class — specific (HIC3) Antineoplastics,Miscellaneous
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ETOPOPHOS 100 MG VIAL
FDB brand name Etopophos
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 027350
  • GCN: 07552
  • HICL (First Databank): 011549
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 226719
Why two NDCs? The FDA registers this code as 61269-410-20 — 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 → 61269-0410-20. 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 Topoisomerase Inhibitor class.

Pharmacologic class Topoisomerase Inhibitor
Drug family (ATC) Podophyllotoxin derivatives
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 ETOPOPHOS 100 MG VIAL Ingredient Etoposide Phosphate
📖 What it is MedlinePlus · NLM

Etoposide injection is used in combination with other medications to treat cancer of the testicles that has not improved or that has worsened after treatment with other medications or radiation therapy. Etoposide injection is also used in combination with other medications to treat a certain type of lung cancer (small cell lung cancer; SCLC). Etoposide is in a class of medications known as podophyllotoxin derivatives. It works by slowing or stopping the growth of cancer cells in your body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a chemotherapy medicine used with other cancer drugs. It is used for small cell lung cancer, and the injection forms are also used for refractory testicular cancer, meaning ca...
  • It comes as an IV injection given by your healthcare team, slowly over time, or as capsules you take by mouth. It's given in repeated courses, usually every 3 to 4 weeks. Capsules...
  • Common ones are low blood counts, nausea and vomiting, poor appetite, diarrhea, mouth sores, and hair loss. Hair loss is usually reversible, and nausea can often be controlled with...
  • Call right away for fever, chills, or signs of infection, unusual bleeding or bruising, or trouble breathing. Also report swelling of the face or tongue, a severe rash, or pain and...
📖 Read our full Etoposide 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 $6.40 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9181 $1.018 / J9181 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)61269-410-20
11-digit billing NDC61269-0410-20
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9181
DescriptorINJECTION, ETOPOSIDE, 10 MG
Billing units / pkg10 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 10 MG, so one package = 10 billing units.
Medicare Part B spend (2026 (Q1))$111,123 · 6,509 claims · $17.07 per claim (all NDCs under J9181)
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
61269-0410-20 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2009-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Etopophos 100 mgthis 61269-0410-20 H2-Pharma, 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2009
On the market since
Jun 2009
📍
2026
Currently FDA-listed
17 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 Etoposide 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.

  • 300 mg UNII K3R6ZDH4DU
    Dextran 40 is a sugar-based polymer derived from bacteria. It acts as a thickener and volume expander in liquid medicines, helping achieve proper consistency and stability.
  • 32.7 mg UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.

2 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

LabelerH2-Pharma, LLC
Application holderCHEPLAPHARM ARZNEIMITTEL GMBH
FDA applicationNDA020457 (NDA)
Labeler code61269
First marketedJun 2009
Product typeHuman Prescription Drug
Portfolio27 products on file

More NDCs from H2-Pharma, LLC labeler code 61269

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. 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 85 words ▾

1 INDICATIONS AND USAGE ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. ( 1.1 ) Small cell lung cancer, in combination with cisplatin, as first-line treatment. ( 1.2 )

1.1Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors.

1.2Small Cell Lung Cancer ETOPOPHOS is indicated, in combination with cisplatin, for first-line treatment of patients with small cell lung cancer.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Refractory testicular tumors: 50 to 100 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours on days 1 through 5, or 100 mg/m 2 administered intravenously over 5 minutes to 3.5 hours on days 1, 3, and 5. ( 2.1 ) Small cell lung cancer: 35 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours for 4 days or 50 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours for 5 days. ( 2.2 ) Do not give by bolus injection.

( 2.4 ) Renal impairment: Reduce the recommended dose to 75% in patients with creatinine clearance 15 to 50 mL/min. ( 2.3 )

2.1Refractory Testicular Tumors The recommended dose of ETOPOPHOS is: 50 to 100 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours on days 1 through 5 of each 21-day (or 28-day cycle), or 100 mg/m 2 administered intravenously over 5 minutes to 3.5 hours on days 1, 3, and 5 of each 21-day (or 28-day cycle).

2.2Small Cell Lung Cancer The recommended dose of ETOPOPHOS is: • 35 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours for 4 days, or • 50 mg/m 2 per day administered intravenously over 5 minutes to 3.5 hours for 5 days.

2.3Dosage Modification In patients with a creatinine clearance (CLcr) 15-50 mL/min, administer 75% of the recommended dose. Data are not available in patients with CLcr less than 15 mL/min. Consider further dose reduction in these patients.

2.4Preparation and Administration Preparation Reconstitute with Sterile Water for Injection, USP; 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; Bacteriostatic Water for Injection with Benzyl Alcohol; or Bacteriostatic Sodium Chloride for Injection with Benzyl Alcohol, using the quantity of diluent shown below: Vial Strength Volume of Diluent Final Concentration 100 mg 5 mL 20 mg/mL 10 mL 10 mg/mL Following reconstitution, ETOPOPHOS can be further diluted to concentrations as low as 0.1 mg/mL with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP.

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration whenever solution and container permit. Storage After reconstitution, store under the following conditions: Refrigerated 2° to 8°C (36° to 46°F) for 7 days; Room temperature at 20° to 25°C (68° to 77°F) for 24 hours following reconstitution with Sterile Water for Injection, USP, 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP; Room temperature 20° to 25°C (68° to 77°F) for 48 hours following reconstitution with Bacteriostatic Water for Injection with benzyl alcohol or Bacteriostatic Sodium Chloride for Injection with benzyl alcohol.

Reconstituted ETOPOPHOS solutions further diluted as directed can be stored under refrigeration 2° to 8°C (36° to 46°F) or at room temperature 20° to 25°C (68° to 77°F) for 24 hours. Administration DO NOT GIVE ETOPOPHOS BY BOLUS INTRAVENOUS INJECTION. ETOPOPHOS solutions may be administered at infusion rates up to 3.5 hours.

Extravasation of ETOPOPHOS may result in swelling, pain, cellulitis, and necrosis including skin necrosis. ETOPOPHOS is a cytotoxic drug. Follow applicable special handling and disposal procedures.

1 To minimize the risk of dermal exposure, use of gloves is recommended. If dermal contact occurs, immediately and thoroughly wash areas of skin contact with soap and water and flush mucosa with water.

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 114 mg etoposide phosphate (equivalent to 100 mg etoposide), white to off-white, lyophilized powder in single-dose vial for reconstitution [see Description (11) ] . For injection: 114 mg etoposide phosphate (equivalent to 100 mg etoposide), white to off-white, lyophilized powder in single-dose vial for reconstitution. ( 3 , 11 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS ETOPOPHOS is contraindicated in patients with a history of a severe hypersensitivity reaction to etoposide products [see Warnings and Precautions (5.3) ] . Hypersensitivity to etoposide products. ( 4 , 5.3 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS ​ Myelosuppression : Obtain complete blood counts prior to each cycle and more frequently as clinically indicated. ( 5.1 ) Secondary leukemias : Can occur with long-term use. ( 5.2 ) Hypersensitivity reactions : Hypersensitivity reactions including anaphylaxis may occur.

( 5.3 ) Embryo-fetal toxicity : ETOPOPHOS can cause fetal harm. Advise females of potential risk to the fetus and to use effective contraception during treatment with ETOPOPHOS and for 6 months after final dose. Advise males to use effective contraception for 4 months, after the last dose of ETOPOPHOS.

( 5.4 , 8.1 , 8.3 )

5.1Myelosuppression ETOPOPHOS causes myelosuppression that results in thrombocytopenia and neutropenia. Fatal infections (including opportunistic infections like Pneumocystis jirovecii pneumonia) and bleeding have occurred. Obtain complete blood counts prior to each cycle of ETOPOPHOS and more frequently as clinically indicated [see Adverse Reactions (6.1)] .

5.2Secondary Leukemias Secondary leukemias have occurred with long term use of ETOPOPHOS.

5.3Hypersensitivity Reactions ETOPOPHOS can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis [see Adverse Reactions (6.1)] . If hypersensitivity reactions occur, immediately interrupt ETOPOPHOS and institute supportive management. Permanently discontinue ETOPOPHOS in patients who experience a severe hypersensitivity reaction.

5.4Embryo-Fetal Toxicity Based on animal studies and its mechanism of action, ETOPOPHOS can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential hazard to the fetus [see Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with ETOPOPHOS and for at least 6 months after the final dose.

Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose [see Use in Specific Populations ( 8.3 )] .

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Secondary leukemias [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Most common adverse reaction is neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact the Safety Call Center at 1-866-885-0690 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, adverse reaction rates, observed in the clinical trials of a drug, cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ETOPOPHOS has been used as a single agent in clinical studies involving 206 patients with a variety of malignancies (including one non-Hodgkin’s lymphoma) and in combination with cisplatin in 60 patients with small cell lung cancer.

The most common adverse reaction was neutropenia. Other Important Adverse Reactions Gastrointestinal Toxicity Nausea and vomiting are the major gastrointestinal toxicities. The severity of nausea and vomiting is generally mild to moderate, with treatment discontinuation required in 1% of patients.

Nausea and vomiting are managed with standard antiemetic therapy. Other Toxicities Other clinically important adverse reactions in clinical trials were: Gastrointestinal: abdominal pain, constipation, dysphagia General: fever Ocular: transient cortical blindness, optic neuritis Respiratory: interstitial pneumonitis/pulmonary fibrosis Skin: pigmentation, radiation recall dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis Neurologic: seizure, aftertaste Hepatobiliary disorder: hepatotoxicity

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of ETOPOPHOS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Extravasation Extravasation, resulting in local soft tissue toxicity.

Extravasation of ETOPOPHOS can result in swelling, pain, cellulitis, and necrosis, including skin necrosis. Acute Renal Failure Reversible cases of acute renal failure have been reported with administration of high dose (2220 mg/m 2 ) ETOPOPHOS with total body irradiation used for hematopoietic stem cell transplantation. The ETOPOPHOS formulation contains dextran 40, which has been associated with acute renal failure when administered in high doses.

🔄 Drug Interactions 36 words ▾

7 DRUG INTERACTIONS Warfarin: Co-administration of ETOPOPHOS with warfarin can result in elevated international normalized ratio (INR). Measure INR frequently. Warfarin: Co-administration can result in elevated international normalized ratio (INR). Measure INR frequently. ( 7 )

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Do not breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on animal data and its mechanism of action, ETOPOPHOS can cause fetal harm when administered to a pregnant woman. Etoposide, the active moiety of etoposide phosphate is teratogenic in mice and rats (see Data) . Advise pregnant women of the potential hazard to a fetus.

Advise women of childbearing potential to avoid becoming pregnant. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 0.05 times of the 50 mg/m 2 human dose based on body surface area [BSA]) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 0.14 and 0.5 times the 50 mg/m 2 human dose based on BSA) resulted in 90% and 100% embryonic resorptions.

In mice, a single etoposide dose of 1.0 mg/kg (approximately 0.06 times the 50 mg/m 2 human dose based on BSA) administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An intraperitoneal dose of 1.5 mg/kg (about 0.1 times the 50 mg/m 2 human based on BSA) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight [see Nonclinical Toxicology (13.1) ] .

8.2Lactation There is no information regarding the presence of etoposide in human milk or its effects on breastfed infant milk production. Because of the potential for serious adverse reactions in nursing infants from ETOPOPHOS, advise women not to breastfeed during treatment with ETOPOPHOS.

8.3Females and Males of Reproductive Potential Contraception Females Advise females of reproductive potential to use effective contraception during treatment with ETOPOPHOS and for 6 months after the final dose. Males ETOPOPHOS may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during treatment with ETOPOPHOS and for 4 months after the final dose.

Infertility Females In females of reproductive potential, ETOPOPHOS may cause infertility and result in amenorrhea. Premature menopause can occur with ETOPOPHOS. Recovery of menses and ovulation is related to age at treatment.

Males In male patients, ETOPOPHOS may result in oligospermia, azoospermia, and permanent loss of fertility. Sperm counts have been reported to return to normal levels in some men, and in some cases, have occurred several years after the end of therapy [See Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of etoposide did not include sufficient numbers (n=71) of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

🆘 Overdosage 21 words ▾

10 OVERDOSAGE No antidote has been established for ETOPOPHOS overdosage in humans. Based on animal studies, overdosage may result in neurotoxicity.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Etoposide phosphate is a prodrug that is converted to its active moiety, etoposide, by dephosphorylation. Etoposide causes the induction of DNA strand breaks by an interaction with DNA-topoisomerase II or the formation of free radicals, leading to cell cycle arrest, primarily at the G2 stage of the cell cycle, and cell death.

12.2Pharmacodynamics Following intravenous administration of 90, 100, and 110 mg/m 2 dose of ETOPOPHOS over 60 minutes, mean nadir values (expressed as percent decrease from baseline) for granulocytes, hemoglobin, and thrombocytes were 81.0 ± 16.5%, 21.4 ± 9.9%, and 44.1 ± 20.7%, respectively.

12.3Pharmacokinetics Following intravenous administration of an etoposide formulation, the area under the concentration time curve (AUC) and maximum plasma concentration (C max ) values increased linearly and etoposide did not accumulate in the plasma following daily administration for 4 to 5 days. Distribution Following administration of an injectable etoposide formulation, the mean volume of distribution of etoposide at steady state was 18 to 29 liters. Etoposide enters the CSF poorly.

In vitro, etoposide is 97% bound to human plasma proteins, primarily albumin. Elimination The terminal elimination half-life of etoposide ranges from 4 to 11 hours. Total body clearance values range from 33 to 48 mL/min.

Metabolism Following intravenous administration of ETOPOPHOS, etoposide phosphate is completely converted to etoposide in plasma. Etoposide is metabolized by opening of the lactone ring, O-demethylation, and conjugation (i.e., glucuronidation and sulfation). O-demethylation occurs through the CYP450 3A4 isoenzyme pathway to produce the active catechol metabolite.

Excretion At 120 hours after intravenous administration of radiolabeled etoposide formulation, the mean recovery of radioactivity in the urine was 56% of the dose, 45% of which was excreted as etoposide and 8% or less as metabolites. Fecal recovery of radioactivity was 44% of the dose. Specific Populations Following intravenous administration of etoposide in adults, the total body clearance of etoposide was correlated with creatinine clearance, serum albumin concentration, and non-renal clearance.

No clinically significant differences in the pharmacokinetics of etoposide were observed based on age and sex. Drug Interaction Studies Cisplatin: Co-administration of cisplatin may increase exposure to etoposide. Highly protein-bound drugs: Phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide in vitro.

Select antiepileptic medications: Co-administration with antiepileptic medications including phenytoin, phenobarbital, carbamazepine, and valproic acid may increase etoposide clearance. Etoposide may be a substrate of the P-glycoprotein (P-gp) transporter system based upon in vitro studies.

📦 How Supplied / Storage and Handling 66 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied/Storage ETOPOPHOS is supplied as a single-dose vial containing etoposide phosphate equivalent to 100 mg etoposide as a lyophilized powder for reconstitution, individually packaged in a carton: NDC 61269-410-20 Store unopened vials at 2° to 8°C (36°-46°F). Keep vial in outer carton to protect from light. Handling ETOPOPHOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

📋 Description 81 words ▾

11 DESCRIPTION ETOPOPHOS (etoposide phosphate) is a topoisomerase inhibitor. The chemical name for etoposide phosphate is: 4'-Demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside], 4' (dihydrogen phosphate). Etoposide phosphate has the following structure: Etoposide phosphate is a phosphate ester of etoposide, a semi-synthetic derivative of podophyllotoxin.

ETOPOPHOS is available for intravenous infusion as a sterile lyophilized powder in single-dose vials for reconstitution containing 114 mg etoposide phosphate, equivalent to 100 mg etoposide, 32.7 mg sodium citrate USP, and 300 mg dextran 40. Image Etoposide Phosphate Chemical Structure

💬 Information for Patients 173 words ▾

17 PATIENT COUNSELING INFORMATION Myelosuppression Advise patients that periodic monitoring of their blood counts is required. Advise patients to contact their healthcare provider for new onset of bleeding, fever, or symptoms of infection [see Warnings and Precautions (5.1)] . Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations ( 8.1 , 8.3 )] .

Advise females of reproductive potential to use effective contraception during and 6 months after treatment with ETOPOPHOS [see Warnings and Precautions (5.4) and Use in Specific Populations ( 8.1 , 8.3 )] . Advise males with female sexual partners of reproductive potential to use condoms during treatment with ETOPOPHOS and for at least 4 months after the final dose [see Warnings and Precautions (5.4) and Use in Specific Populations ( 8.3 )] . Licensed by: CHEPLAPHARM Arzneimittel GmbH 17489 Greifswald, Germany Product of Germany Distributed by: H2-Pharma, LLC Montgomery, AL 36117, USA

🔬 Clinical Studies 122 words ▾

14 CLINICAL STUDIES Study 1 was a multicenter trial in patients, with previously untreated, small cell lung cancer, randomized (1:1) to receive either etoposide phosphate (80 mg/m 2 /day) plus cisplatin (20 mg/m 2 /day) for 5 days, or etoposide (80 mg/m 2 /day) plus cisplatin (20 mg/m 2 /day). The major efficacy outcome measure was objective response rate (ORR). Among the 121 patients enrolled, the median age was 64 years, 65% of patients were male, 89% were White, and ECOG performance score was 0 to 2.

Study 1 demonstrated an overall response rate of 61% (95% confidence interval [CI] 47, 73) for patients treated with etoposide phosphate plus cisplatin, and 58% (95% CI: 45, 71) for those receiving etoposide plus cisplatin.

🧪 Nonclinical Toxicology 112 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility ETOPOPHOS was non-mutagenic in an in vitro Ames microbial mutagenicity assay; however, ETOPOPHOS is rapidly and completely converted to etoposide in vivo. Therefore, as etoposide is mutagenic in the Ames assay, ETOPOPHOS is considered mutagenic in vivo. In rats, oral dosing of ETOPOPHOS for 5 consecutive days at doses greater than or equal to 86 mg/kg/day (about 10 times the 50 mg/m 2 human dose based on BSA) resulted in irreversible testicular atrophy.

Irreversible testicular atrophy was also present in rats treated with ETOPOPHOS intravenously for 30 days at 5.11 mg/kg/day (about 0.5 times the 50 mg/m 2 human dose based on BSA).

📚 References 9 words ▾

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

📄 Recent Major Changes 6 words ▾

Warnings and Precautions, Myelosuppression (5.1) 7/2026

📄 Package Label / Principal Display Panel 45 words ▾

--------------------------------------------------------------------------------------------------------- ETOPOPHOS 100 mg for Injection Representative Packaging See How Supplied section for a complete list of available packages of ETOPOPHOS. NDC 61269-410-20 Single-Dose Vial ETOPOPHOS ® (etoposide phosphate) for Injection For IV use Etoposide phosphate equivalent to 100 mg etoposide Rx only Image etopophos100mg-lbl

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
178
Units reimbursed last 4 qtrs
1.7K
Gross reimbursed last 4 qtrs
$10.8K
Avg / prescription
$60.91
Avg / unit
$6.4036
Latest quarter Q4 2025
31Rx
Fee-for-service vs managed care ⓘ
13% FFS 87% MCO
Fee-for-service · 24 Rx Managed care · 154 Rx
State Medicaid map
Alaska: no data reported AK Maine: 240 units · 17.2 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 285 units · 1.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 140 units · 2.0 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 682 units · 9.7 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 327 units · 3.8 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 19 units · 0.9 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.917.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maine 17.2 /100k
2 Massachusetts 9.7 /100k
3 Virginia 3.8 /100k
4 Indiana 2.0 /100k
5 New York 1.5 /100k
6 New Mexico 0.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 ETOPOPHOS (this brand).

Top reported reactions

Disease Progression163
Thrombocytopenia82
Acute Kidney Injury78
Pyrexia70
Febrile Neutropenia65
Neutropenia61
Product Storage Error61

Age at onset

Neonate7
Infant1
Child9
Adolescent14
Adult190
Elderly49

Reporter sex

1,605 reports
Male · 57%
Female · 43%
Unknown · 1%

Serious outcomes

Hospitalization585
Life-threatening227
Disabling31
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 139 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 H2-Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
H2-Pharma, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9181 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.
← 61269-0404-60 · H2-Pharma 61269-0460-90 · H2-Pharma →
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.