Home › NDC Lookup › Ingredients › Ibritumomab Tiuxetan › 72893-0007-04
Zevalin ibritumomab tiuxetan Kit — NDC 72893-0007-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zevalin ibritumomab tiuxetan Kit — NDC 72893-007-04 (Billing 72893-0007-04)

by Acrotech Biopharma Inc · 1 KIT in 1 CARTON * 10 mL in 1 VIAL * 2 mL in 1 VIAL * 2 mL in 1 VIAL

This is a package of Zevalin ibritumomab tiuxetan Kit from Acrotech Biopharma Inc, marketed since Feb 2002 and currently FDA-listed. It is this product's only package size.

NDC 72893-0007-04
🏷️ FDA NDC (as labeled) 72893-007-04 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 Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 72893-007-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72893 labeler · 007 product · 04 package
Package marketed since
Feb 19, 2002
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7289300704 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72893-007-04
Product NDC 72893-007
11-digit billing NDC 72893000704
NCPDP billing unit EA — each (per item)
Application # BLA125019
SPL Set ID 25d367dc-da65-44c9-a844-1bf15339c285
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-02-19
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GPI-14 21358035406420
GPI class Zevalin Y-90
GCN Seq No 051201
GCN 18373
HICL code 024430
Ingredient (HICL) Kit Y-90/Ibritumomab/H.albumin
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1K
Therapeutic class — specific (HIC3) Antineoplastics Antibody/Antibody-Drug Complexes
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ZEVALIN Y-90 VIAL
FDB brand name Zevalin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051201
  • GCN: 18373
  • GPI-14 (Medi-Span): 21358035406420
  • HICL (First Databank): 024430
  • AHFS class code: 10:00.00.00
Why two NDCs? The FDA registers this code as 72893-007-04 — 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 → 72893-0007-04. 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.

Clinical

Label name ZEVALIN Y-90 VIAL Ingredient Kit Y-90/Ibritumomab/H.albumin

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 eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72893-0007-04 You're viewing this Main listing 1 KIT in 1 CARTON * 10 mL in 1 VIAL * 2 mL in 1 VIAL * 2 mL in 1 VIAL 2002-02-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zevalinthis 72893-0007-04 Acrotech 1 kit — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
2002
First FDA approval
Feb 2002
📍
2026
Currently FDA-listed
24 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Zevalinibritumomab tiuxetan
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAcrotech Biopharma Inc
FDA applicationBLA125019 (BLA)
Labeler code72893
First marketedFeb 2002
Product typeHuman Prescription Drug
Portfolio8 products on file

More NDCs from Acrotech Biopharma Inc labeler code 72893

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion [ see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ] .

Discontinue rituximab and Y-90 Zevalin infusions in patients who develop severe infusion reactions. Prolonged and Severe Cytopenias: Y-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Do not administer Y-90 Zevalin to patients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve [ see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 ) ].

Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the Zevalin therapeutic regimen. Discontinue rituximab and Y-90 Zevalin infusions in patients experiencing severe cutaneous or mucocutaneous reactions [ see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 ) ]. Dosing: The dose of Y-90 Zevalin should not exceed 32 mCi (1184 MBq) [ see Dosage and Administration ( 2.2 ) ].

WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS See full prescribing information for complete boxed warning Serious Infusion Reactions, some fatal, may occur within 24 hours of rituximab infusion. ( 5.1 ) Prolonged and Severe Cytopenias occur in most patients. ( 5.2 ) Severe Cutaneous and Mucocutaneous Reactions, some fatal, reported with Zevalin therapeutic regimen.

( 5.3 , 6.2 ) Do not exceed 32 mCi (1184 MBq) of Y-90 Zevalin. ( 2.2 )

🎯 Indications and Usage 113 words ▾

1 INDICATIONS AND USAGE Zevalin is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen indicated for the treatment of adult patients with: relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) ( 1.1 ). previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy ( 1.2 ).

1.1Relapsed or Refractory, Low-grade or Follicular NHL Zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).

1.2Previously Untreated Follicular NHL Zevalin is indicated for the treatment of previously untreated follicular NHL in adult patients who achieve a partial or complete response to first-line chemotherapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Day 1 : Administer rituximab 250 mg/m 2 intravenous infusion. ( 2.2 ) Day 7, 8, or 9 : Administer rituximab 250 mg/m 2 intravenous infusion. ( 2.2 ) If platelets at least 150,000/mm 3 : Within 4 hours after rituximab infusion, administer 0.4 mCi/kg (14.8 MBq per kg) Y-90 Zevalin intravenous infusion.

If platelets 100,000 to 149,000/mm 3 in relapsed or refractory patients: Within 4 hours after rituximab infusion, administer 0.3 mCi/kg (11.1 MBq per kg) Y-90 Zevalin intravenous infusion.

2.1Recommended Dosing Schedule Administer the Zevalin therapeutic regimen as outlined below. Initiate the Zevalin therapeutic regimen following recovery of platelet counts to 150,000/mm 3 or more at least 6 weeks, but no more than 12 weeks, following the last dose of first-line chemotherapy. Only administer rituximab/Zevalin in facilities where immediate access to resuscitative measures is available. Overview of Dosing Schedule Zevalin Dosing Schedule

2.2Zevalin Therapeutic Regimen Dosage and Administration Day 1: Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally prior to rituximab infusion. Administer rituximab 250 mg/m 2 intravenously at an initial rate of 50 mg/hr. In the absence of infusion reactions, escalate the infusion rate in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.

Do not mix or dilute rituximab with other drugs. Immediately stop the rituximab infusion for serious infusion reactions and discontinue the Zevalin therapeutic regimen [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ]. Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions.

If symptoms improve, continue the infusion at one-half the previous rate. Day 7, 8 or 9: Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally prior to rituximab infusion. Administer rituximab 250 mg/m 2 intravenously at an initial rate of 100 mg/hr.

Increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr, as tolerated. If infusion reactions occurred during rituximab infusion on Day 1 of treatment, administer rituximab at an initial rate of 50 mg/hr and escalate the infusion rate in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. Administer Y-90 Zevalin injection through a free flowing intravenous line within 4 hours following completion of rituximab infusion.

Use a 0.22 micron low-protein-binding in-line filter between the syringe and the infusion port. After infusion, flush the line with at least 10 mL of normal saline. If platelet count at least 150,000/mm 3 , administer Y-90 Zevalin over 10 minutes as an intravenous infusion at a dose of Y-90 0.4 mCi per kg (14.8 MBq per kg) actual body weight.

If platelet count 100,000 to 149,000/mm 3 , in relapsed or refractory patients, administer Y-90 Zevalin over 10 minutes as an intravenous infusion at a dose of Y-90 0.3 mCi per kg (11.1 MBq per kg) actual body weight. Do not administer more than 32 mCi (1184 MBq) Y-90 Zevalin dose regardless of the patient’s body weight. Monitor patients closely for evidence of extravasation during the infusion of Y-90 Zevalin.

Immediately stop infusion and restart in another limb if any signs or symptoms of extravasation occur [ see Warnings and Precautions ( 5.5 ) ].

2.3Directions for Preparation of Radiolabeled Y-90 Zevalin Doses A clearly-labeled kit is required for preparation of Yttrium-90 (Y-90) Zevalin. Follow the detailed instructions for the preparation of radiolabeled Zevalin [ see Dosage and Administration ( 2.4 ) ]. Required materials not supplied in the kit: Yttrium-90 Chloride Sterile Solution Three sterile 1 mL plastic syringes One sterile 3 mL plastic syringe Two sterile 10 mL plastic syringes with 18-20 G needles ITLC silica gel strips 0.9% Sodium Chloride aqueous solution for the chromatography solvent Developing chamber for chromatography Suitable radioactivity counting apparatus Filter, 0.22 micrometer, low-protein… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 3.2 mg ibritumomab tiuxetan per 2 mL as a clear, colorless solution, that may contain translucent particles, in a single-dose vial. Injection: 3.2 mg per 2 mL in a single-dose vial. ( 3 )

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious Infusion Reactions: Immediately discontinue rituximab and Y-90 Zevalin. ( 5.1 , 6.1 ) Prolonged and Severe Cytopenias: Do not administer Zevalin to patients with ≥ 25% lymphoma marrow involvement or impaired bone marrow reserve. ( 5.2 , 6.1 ) Severe Cutaneous and Mucocutaneous Reactions: Discontinue rituximab and Zevalin infusions if patients develop severe cutaneous or mucocutaneous reactions.

( 5.3 , 6.2 ) Development of Leukemia and Myelodysplastic Syndrome: Monitor patients for hematological toxicity including secondary malignancies. ( 5.4 , 6.1 ) Extravasation: Monitor for extravasation and terminate infusion if it occurs. Resume infusion in another limb.

( 5.5 , 6.2 ) Immunization: Do not administer live viral vaccines to patients who recently received Zevalin. ( 5.6 ) Embryo-fetal Toxicity: May cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

( 5.8 , 8.1 , 8.3 )

5.1Serious Infusion Reactions Rituximab, alone or as a component of the Zevalin therapeutic regimen, can cause severe, including fatal, infusion reactions. These reactions typically occur during the first rituximab infusion with time to onset of 30 to 120 minutes. Signs and symptoms of severe infusion reactions may include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, and cardiogenic shock.

Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions. Immediately discontinue rituximab and Y-90 Zevalin administration for severe infusion reactions. Only administer rituximab/Zevalin in facilities where immediate access to resuscitative measures is available [ see Boxed Warning and Dosage and Administration ( 2.2 ) ].

See also prescribing information for rituximab.

5.2Prolonged and Severe Cytopenias Cytopenias with delayed onset and prolonged duration, some complicated by hemorrhage and severe infection, are the most common severe adverse reactions of the Zevalin therapeutic regimen. When used according to recommended doses, the incidences of severe thrombocytopenia and neutropenia are greater in patients with mild baseline thrombocytopenia (≥ 100,000 but ≤ 149,000/mm 3 ) compared to those with normal pretreatment platelet counts. Severe cytopenias persisting more than 12 weeks following administration can occur.

Monitor complete blood counts (CBC) and platelet counts following the Zevalin therapeutic regimen weekly until levels recover or as clinically indicated [ see Boxed Warning and Adverse Reactions ( 6.1 ) ]. Do not administer the Zevalin therapeutic regimen to patients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve. Monitor patients for cytopenias and their complications (e.g., febrile neutropenia, hemorrhage) for up to 3 months after use of the Zevalin therapeutic regimen.

Avoid using drugs which interfere with platelet function or coagulation following the Zevalin therapeutic regimen.

5.3Severe Cutaneous and Mucocutaneous Reactions Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis, some fatal, were reported in post-marketing experience. The time to onset of these reactions was variable, ranging from a few days to 4 months after administration of the Zevalin therapeutic regimen. Discontinue the Zevalin therapeutic regimen in patients experiencing a severe cutaneous or mucocutaneous reaction [ see Boxed Warning and Adverse Reactions ( 6.2 ) ].

5.4Risk of Developing Myelodysplastic Syndrome, Leukemia, and Other Malignancies The radiation dose resulting from therapeutic exposure to Y-90 radiolabeled Zevalin may result in secondary malignancies. Myelodysplastic syndrome (MDS) and/or acute myelogenous leukemia (AML) were reported in 5.2% (11/211) of patients with relapsed or refractory NHL enrolled in clinical studies and 1.5% (8/5… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Serious Infusion Reactions [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ] . Prolonged and Severe Cytopenias [ see Boxed Warning and Warnings and Precautions ( 5.2 ) ]. Severe Cutaneous and Mucocutaneous Reactions [ see Boxed Warning and Warnings and Precautions ( 5.3 ) ].

Leukemia and Myelodysplastic Syndrome [ see Warnings and Precautions ( 5.4 ) ]. Common adverse reactions ( > 10%) in clinical trials were: cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc. at 1-866-298-8433 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. The reported safety data reflects exposure to Zevalin in 349 patients with relapsed or refractory, low-grade, follicular or transformed NHL across 5 trials (4 single arm and 1 randomized) and in 206 patients with previously untreated follicular NHL in a randomized trial (FIT study) who received any portion of the Zevalin therapeutic regimen.

The safety data reflect exposure to Zevalin in 270 patients with relapsed or refractory NHL with platelet counts ≥150,000/ mm 3 who received 0.4 mCi/kg (14.8 MBq/kg) of Y-90 Zevalin (Group 1 in Table 4 ), 65 patients with relapsed or refractory NHL with platelet counts of ≥ 100,000 but ≤ 149,000 /mm 3 who received 0.3 mCi/kg (11.1 MBq/kg) of Y-90 Zevalin (Group 2 in Table 4 ), and 204 patients with previously untreated NHL with platelet counts ≥150,000/ mm 3 who received 0.4 mCi/kg (14.8 MBq/kg) of Y-90 Zevalin; all patients received a single course of Zevalin.

The most common adverse reactions of Zevalin are cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia. The most serious adverse reactions of Zevalin are prolonged and severe cytopenias (thrombocytopenia, anemia, lymphopenia, neutropenia) and secondary malignancies. Because the Zevalin therapeutic regimen includes the use of rituximab, see prescribing information for rituximab.

Table 2 displays selected adverse reaction incidence rates in patients who received any portion of the Zevalin therapeutic regimen (n=206) or no further therapy (n=203) following first-line chemotherapy (FIT study). Table 2. Per-Patient Incidence (%) of Selected Between-group difference of ≥5% Adverse Reactions Occurring in ≥ 5% of Patients with Previously Untreated Follicular NHL Treated with the Zevalin Therapeutic Regimen Zevalin (n=206) Observation (n=203) All Grades NCI CTCAE version

2.0Grade 3-4 All Grades Grade 3-4 % % % % Gastrointestinal Disorders Abdominal pain 17 2 13 <1 Diarrhea 11 0 3 0 Nausea 18 0 2 0 Body as a Whole Asthenia 15 1 8 <1 Fatigue 33 1 9 0 Influenza-like illness 8 0 3 0 Pyrexia 10 3 4 0 Musculoskeletal Myalgia 9 0 3 0 Metabolism Anorexia 8 0 2 0 Respiratory, Thoracic & Media Cough 11 <1 5 0 Pharyngolaryngeal pain 7 0 2 0 Epistaxis 5 2 <1 0 Nervous System Dizziness 7 0 2 0 Vascular Hypertension 7 3 2 <1 Skin & Subcutaneous Night sweats 8 0 2 0 Petechiae 8 2 0 0 Pruritus 7 0 1 0 Rash 7 0 <1 0 Infections & Infestations Bronchitis 8 0 3 0 Nasopharyngitis 19 0 10 0 Rhinitis 8 0 2 0 Sinusitis 7 <1 <1 0 Urinary tract infection 7 <1 3 0 Blood and Lymphatic System Thrombocytopenia 62 51 1 0 Neutropenia 45 41 3 2 Anemia 22 5 4 0 Leukopenia 43 36 4 1 Lymphopenia 26 18 9 5 Table 3 shows hematologic toxicities in 349 Zevalin-treated patients with relapsed or refractory, low-grade, follicular or transformed B-cell NHL.

Grade 2-4 hematologic toxicity occurred in 86% of Zevalin-treated patients. Table 3. Per-Patient Incidence (%) of… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 49 words ▾

7 DRUG INTERACTIONS Patients receiving medications that interfere with platelet function or coagulation should have more frequent laboratory monitoring for thrombocytopenia. No formal drug interaction studies have been performed with Zevalin. Monitor patients receiving medications that interfere with platelet function or coagulation more frequently for thrombocytopenia. ( 7 )

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on its radioactivity, Y-90 Zevalin may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Immunoglobulins are known to cross the placenta. There are no available data on Zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Advise women of childbearing potential to use adequate contraception for a minimum of twelve months. Inform women who become pregnant while receiving Zevalin of the potential fetal risks. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

8.2Lactation Risk Summary There are no data on the presence of Zevalin or its metabolites in human milk, the effects of Zevalin on the breastfed child, or its effects on milk production. Because human IgG is excreted in human milk, it is expected that Zevalin would be present in human milk. Due to the potential for serious adverse reactions in a breastfeeding child from Zevalin, advise lactating women to avoid breastfeeding during treatment with the Zevalin therapeutic regimen and for 6 months after the last dose.

8.3Females and Males of Reproductive Potential Zevalin may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Conduct pregnancy testing in females of reproductive potential prior to treatment with Zevalin. Contraception Females Based on its radioactivity, Y-90 Zevalin may cause fetal harm.

Advise females of reproductive potential to use effective contraceptive methods during treatment and for 12 months after the last dose of the Zevalin therapeutic regimen [see Clinical Pharmacology ( 12.1 )] . Males Based on its radioactivity, Y-90 Zevalin may cause fetal harm. Advise males with female partners of reproductive potential to use effective contraceptive methods during treatment and for 12 months after the final dose of the Zevalin therapeutic regimen [see Clinical Pharmacology ( 12.1 )].

Infertility Based on its radioactivity, there is a potential risk that the Zevalin therapeutic regimen could cause toxic effects on the male and female gonads [see Clinical Pharmacology ( 12.1 ) and Nonclinical Toxicology ( 13.1 )] .

8.4Pediatric Use The safety and effectiveness of Zevalin have not been established in pediatric patients.

8.5Geriatric Use Of 349 patients with relapsed/refractory NHL treated with the Zevalin therapeutic regimen in clinical studies, 38% (132 patients) were age 65 years and over, while 12% (41 patients) were age 75 years and over. Of 414 patients enrolled in the FIT study (Zevalin following first-line chemotherapy) 206 patients received Zevalin. Of these patients 14% (29 patients) were 65 years and over, while 2% (4 patients) were 75 years and older.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 138 words ▾

8.1Pregnancy Risk Summary Based on its radioactivity, Y-90 Zevalin may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . Immunoglobulins are known to cross the placenta. There are no available data on Zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Advise women of childbearing potential to use adequate contraception for a minimum of twelve months. Inform women who become pregnant while receiving Zevalin of the potential fetal risks. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of Zevalin have not been established in pediatric patients.

🧓 Geriatric Use 99 words ▾

8.5Geriatric Use Of 349 patients with relapsed/refractory NHL treated with the Zevalin therapeutic regimen in clinical studies, 38% (132 patients) were age 65 years and over, while 12% (41 patients) were age 75 years and over. Of 414 patients enrolled in the FIT study (Zevalin following first-line chemotherapy) 206 patients received Zevalin. Of these patients 14% (29 patients) were 65 years and over, while 2% (4 patients) were 75 years and older.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 26 words ▾

10 OVERDOSAGE Severe cytopenias which may require stem cell support have occurred at doses higher than the recommended maximum total dose of 32 mCi (1184 MBq).

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ibritumomab tiuxetan binds specifically to the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35). The apparent affinity (K D ) of ibritumomab tiuxetan for the CD20 antigen ranges between approximately 14 to 18 nM. The CD20 antigen is expressed on pre-B and mature B lymphocytes and on > 90% of B-cell non-Hodgkin’s lymphomas (NHL).

The CD20 antigen is not shed from the cell surface and does not internalize upon antibody binding. The chelate tiuxetan, which tightly binds Y-90, is covalently linked to ibritumomab. The beta emission from Y-90 induces cellular damage by the formation of free radicals in the target and neighboring cells.

Ibritumomab tiuxetan binding was observed in vitro on lymphoid cells of the bone marrow, lymph node, thymus, red and white pulp of the spleen, and lymphoid follicles of the tonsil, as well as lymphoid nodules of other organs such as the large and small intestines.

12.2Pharmacodynamics In clinical studies, administration of the Zevalin therapeutic regimen resulted in sustained depletion of circulating B cells. At four weeks, the median number of circulating B cells was zero (range, 0-1084/mm 3 ). B-cell recovery began at approximately 12 weeks following treatment, and the median level of B cells was within the normal range (32 to 341/mm 3 ) by 9 months after treatment.

Median serum levels of IgG and IgA remained within the normal range throughout the period of B-cell depletion. Median IgM serum levels dropped below normal (median 49 mg/dL, range 13-3990 mg/dL) after treatment and recovered to normal values by 6-months post therapy.

12.3Pharmacokinetics Pharmacokinetic and biodistribution studies were performed using In-111 Zevalin (5 mCi [185 MBq] In-111, 1.6 mg ibritumomab tiuxetan). In an early study designed to assess the need for pre-administration of unlabeled antibody, only 18% of known sites of disease were imaged when In-111 Zevalin was administered without unlabeled ibritumomab. When preceded by unlabeled ibritumomab (1.0 mg/kg or 2.5 mg/kg), In-111 Zevalin detected 56% and 92% of known disease sites, respectively.

These studies were conducted with a Zevalin therapeutic regimen that included unlabeled ibritumomab. In pharmacokinetic studies of patients receiving the Zevalin therapeutic regimen, the mean effective half-life for Y-90 activity in blood was 30 hours, and the mean area under the fraction of injected activity (FIA) vs. time curve in blood was 39 hours. Over 7 days, a median of 7.2% of the injected activity was excreted in urine.

🧬 Mechanism of Action 151 words ▾

12.1Mechanism of Action Ibritumomab tiuxetan binds specifically to the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35). The apparent affinity (K D ) of ibritumomab tiuxetan for the CD20 antigen ranges between approximately 14 to 18 nM. The CD20 antigen is expressed on pre-B and mature B lymphocytes and on > 90% of B-cell non-Hodgkin’s lymphomas (NHL).

The CD20 antigen is not shed from the cell surface and does not internalize upon antibody binding. The chelate tiuxetan, which tightly binds Y-90, is covalently linked to ibritumomab. The beta emission from Y-90 induces cellular damage by the formation of free radicals in the target and neighboring cells.

Ibritumomab tiuxetan binding was observed in vitro on lymphoid cells of the bone marrow, lymph node, thymus, red and white pulp of the spleen, and lymphoid follicles of the tonsil, as well as lymphoid nodules of other organs such as the large and small intestines.

📦 How Supplied / Storage and Handling 177 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 72893-007-04). The contents of all vials are sterile, pyrogen-free, contain no preservatives, and are not radioactive. The kit contains four identification labels and the following four vials: One (1) Zevalin vial containing 3.2 mg ibritumomab tiuxetan in 2 mL 0.9% Sodium Chloride as a clear, colorless solution.

One (1) 50 mM Sodium Acetate Vial containing 13.6 mg Sodium Acetate trihydrate in 2 mL Water for Injection, USP as a clear, colorless solution. One (1) Formulation Buffer Vial containing 750 mg Albumin (Human), 76 mg Sodium Chloride, 28 mg Sodium Phosphate Dibasic Dodecahydrate, 4 mg Pentetic Acid, 2 mg Potassium Phosphate Monobasic and 2 mg Potassium Chloride in 10 mL Water for Injection, pH 7.1 as a clear yellow to amber colored solution. One (1) empty Reaction Vial.

Yttrium-90 Chloride Sterile Solution is shipped directly from the supplier upon placement of an order for the Y-90 Zevalin kit. Rituximab must be ordered separately. Storage Store the kit at 2-8°C (36-46°F).

Do not freeze.

📋 Description ~1 min read ▾

11 DESCRIPTION Zevalin (ibritumomab tiuxetan) is the immunoconjugate resulting from a stable thiourea covalent bond between the monoclonal antibody ibritumomab and the linker-chelator tiuxetan [N-[2-bis(carboxymethyl) amino]-3-(p-isothiocyanatophenyl)-propyl]-[N-[2-bis(carboxymethyl)amino]-2- (methyl)-ethyl]glycine. This linker-chelator provides a high affinity, conformationally restricted chelation site for Yttrium-90. The approximate molecular weight of ibritumomab tiuxetan is 148 kD.

The antibody moiety of Zevalin is ibritumomab, a murine IgG 1 kappa monoclonal antibody directed against the CD20 antigen. Ibritumomab tiuxetan is a clear, colorless, sterile, pyrogen-free, preservative-free solution that may contain translucent particles. Each single-use vial includes 3.2 mg of ibritumomab tiuxetan in 2 mL of 0.9% Sodium Chloride.

Physical/Radiochemical Characteristics of Y-90 Yttrium-90 decays by emission of beta particles, with a physical half-life of 64.1 hours (2.67 days). The product of radioactive decay is non-radioactive Zirconium-90. The range of beta particles in soft tissue ( χ 90) is 5 mm.

Radiation emission data for Y-90 are summarized in Table 5 . Table 5. Principal Y-90 Radiation Emission Data Radiation Mean % per Disintegration Mean Energy (keV) Beta minus 100 750-935 External Radiation The exposure rate for 1 mCi (37 MBq) of Y-90 is 8.3 x 10 -3 C/kg/hr (32 R/hr) at the mouth of an open Y-90 vial.

To allow correction for physical decay of Y-90, the fractions that remain at selected intervals before and after the time of calibration are shown in Table 6 . Table 6. Physical Decay Chart: Y-90 Half-life

2.67Days (64.1 Hours) Calibration Time (Hrs.) Fraction Remaining Calibration Time (Hrs.) Fraction Remaining -36 1.48 0 1.00 -24 1.30 1 0.99 -12 1.14 2 0.98 -8 1.09 3 0.97 -7 1.08 4 0.96 -6 1.07 5 0.95 -5 1.06 6 0.94 -4 1.04 7 0.93 -3 1.03 8 0.92 -2 1.02 12 0.88 -1 1.01 24 0.77 0 1.00 36 0.68

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients: To contact a healthcare professional for severe signs and symptoms of infusion reactions. To take premedications as prescribed [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] . To report any signs or symptoms of cytopenias (bleeding, easy bruising, petechiae or purpura, pallor, weakness or fatigue) [see Warnings and Precautions ( 5.2 )] .

To avoid medications that interfere with platelet function, except as directed by a healthcare professional [see Warnings and Precautions ( 5.2 )] . To seek prompt medical evaluation for diffuse rash, bullae, or desquamation of the skin or oral mucosa [see Warnings and Precautions ( 5.3 )] . To immediately report symptoms of infection (e.g. pyrexia) [see Adverse Reactions ( 6.2 )] .

That immunization with live viral vaccines is not recommended for 12 months following the Zevalin therapeutic regimen [see Warnings and Precautions ( 5.6 )] . To use effective contraceptive methods during treatment and for a minimum of 12 months following Zevalin therapy [see Warnings and Precautions ( 5.8 )] , Use in Specific Populations ( 8.1 , 8.3 ) and Nonclinical Toxicology ( 13.1 )] . To discontinue breastfeeding during and for 6 months after the last dose of Zevalin treatment [see Use In Specific Populations ( 8.2 )] .

Zevalin ® (ibritumomab tiuxetan) Manufactured by: Acrotech Biopharma Inc. East Windsor, NJ 08520 U.S. License No.2159 Zevalin ® is a registered trademark of Acrotech Biopharma Inc and its subsidiaries.

Protected by U.S. Patent Nos. 5,736,137, 5,776,456, 5,843,439, 6,207,858, 6,399,061, 6,682,734, 6,994,840, 7,229,620, 7,381,560, 7,422,739 and other patents and patents pending.

🧬 Pharmacokinetics 141 words ▾

12.3Pharmacokinetics Pharmacokinetic and biodistribution studies were performed using In-111 Zevalin (5 mCi [185 MBq] In-111, 1.6 mg ibritumomab tiuxetan). In an early study designed to assess the need for pre-administration of unlabeled antibody, only 18% of known sites of disease were imaged when In-111 Zevalin was administered without unlabeled ibritumomab. When preceded by unlabeled ibritumomab (1.0 mg/kg or 2.5 mg/kg), In-111 Zevalin detected 56% and 92% of known disease sites, respectively.

These studies were conducted with a Zevalin therapeutic regimen that included unlabeled ibritumomab. In pharmacokinetic studies of patients receiving the Zevalin therapeutic regimen, the mean effective half-life for Y-90 activity in blood was 30 hours, and the mean area under the fraction of injected activity (FIA) vs. time curve in blood was 39 hours. Over 7 days, a median of 7.2% of the injected activity was excreted in urine.

🧬 Pharmacodynamics 108 words ▾

12.2Pharmacodynamics In clinical studies, administration of the Zevalin therapeutic regimen resulted in sustained depletion of circulating B cells. At four weeks, the median number of circulating B cells was zero (range, 0-1084/mm 3 ). B-cell recovery began at approximately 12 weeks following treatment, and the median level of B cells was within the normal range (32 to 341/mm 3 ) by 9 months after treatment.

Median serum levels of IgG and IgA remained within the normal range throughout the period of B-cell depletion. Median IgM serum levels dropped below normal (median 49 mg/dL, range 13-3990 mg/dL) after treatment and recovered to normal values by 6-months post therapy.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Relapsed or Refractory, Low-grade or Follicular Lymphoma A study to evaluate the efficacy and safety of Zevalin (referred to as Study 106-06) was a single arm study of 54 patients with relapsed follicular lymphoma, who were refractory to rituximab treatment. Patients had a World Health Organization (WHO) Performance Status (PS) 0-2, <25% bone marrow involvement by NHL, no prior bone marrow transplantation, and acceptable hematologic, renal, and hepatic function. Refractoriness to rituximab was defined as failure to achieve a complete or partial response or time-to-disease-progression (TTP) of < 6 months.

The main efficacy outcome measure of the study was the overall response rate (ORR) using the International Workshop Response Criteria (IWRC). Other efficacy outcome measures included time-to-disease-progression (TTP) and duration of response (DR). Table 7 summarizes efficacy data from Study 106-06.

Another study to evaluate the efficacy and safety of Zevalin (referred to as Study 106-04) was a randomized (1:1), open-label, multicenter study comparing the Zevalin therapeutic regimen with rituximab. The trial was conducted in 130 patients with relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma (NHL); no patient had received prior rituximab. Patients had histologically confirmed NHL requiring therapy, a WHO PS 0-2, <25% bone marrow involvement by NHL, no prior bone marrow transplantation, and acceptable hematologic function.

Sixty-four patients received the Zevalin therapeutic regimen, and 66 patients received rituximab given as an IV infusion at 375 mg per m 2 weekly times 4 doses. The main efficacy outcome measure of the study was ORR using the IWRC. The ORR was significantly higher for patients receiving the Zevalin therapeutic regimen (83% vs.

55%, p<0.001). Time-to-disease-progression was not significantly different between study arms. Table 7 summarizes efficacy data from Study 106-04.

Table 7 . Summary of Efficacy Data IWRC: International Workshop Response Criteria Study 106-06 Study 106-04 Zevalin Therapeutic regimen N = 54 Zevalin Therapeutic regimen N = 64 Rituximab N = 66 Overall Response Rate (%) 74 83 55 Complete Response Rate CRu and CR: Unconfirmed and confirm complete response (%) 15 38 18 Median DR Estimated with observed range Duration of response: interval from the onset of response to disease progression (Months) [Range “+” indicates an ongoing response ] 6.4 [0.5-49.9+] 14.3 [1.8-47.6+] 11.5 [1.2-49.7+] Median TTP Time to Disease Progression: interval from the first infusion to disease progression (Months) [Range ] 6.8 [1.1-50.9+] 12.1 [2.1-49.0+] 10.1 [0.7-51.3+] A single-arm study to evaluate the efficacy and safety of Zevalin (referred to as Study 106-05) was conducted in 30 patients, of whom 27 had relapsed or refractory low-grade, follicular NHL and a platelet count 100,000 to 149,000/mm 3 .

Patients with ≥ 25% lymphomatous marrow involvement, prior myeloablative therapy with stem cell support, prior external beam radiation to > 25% of active marrow or neutrophil count <1,500/mm 3 were ineligible for Study 106-05. All patients received Y-90 Zevalin [0.3 mCi per kg (11.1 MBq per kg)]. Objective, durable clinical responses were observed [89% ORR (95% CI: 70-97%) with a median duration of response of 11.6 months (range: 1.0-42.4+ months)].

14.2Follicular, B-Cell NHL Upon Completion of First-Line Chemotherapy The FIT (First-line Indolent Trial) study (NCT00185393) was a multi-center, randomized, open-label study conducted in patients with follicular NHL with a partial (PR) or complete response (CR/CRu) upon completion of first-line chemotherapy. Randomization was stratified by center and response to first-line therapy (CR or PR). Key eligibility criteria were <25% bone marrow involvement, no prior external beam radiation or myeloablative therapy, and recovery of platelets to normal levels.

Patients were randomized to receive Zevalin (n=208) or no further therapy (… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 150 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutogenicity studies have not been conducted. However, radiation is a potential carcinogen and mutagen. No animal studies have been performed to determine the effects of Zevalin on fertility in males or females.

In clinical studies, the Zevalin therapeutic regimen results in a significant radiation dose to the testes: the radiation dose to the ovaries has not been established [ see Dosage and Administration ( 2.5 )]. There is a potential risk that the Zevalin therapeutic regimen could cause toxic effects on the male and female gonads. Effective contraceptive methods should be used during treatment and for up to 12 months following the Zevalin therapeutic regimen.

13.2Animal Toxicology and/or Pharmacology Animal reproductive toxicology studies of the Zevalin therapeutic regimen have not been conducted. Because the Zevalin therapeutic regimen includes the use of rituximab, also see prescribing information for rituximab.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 113 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity and mutogenicity studies have not been conducted. However, radiation is a potential carcinogen and mutagen. No animal studies have been performed to determine the effects of Zevalin on fertility in males or females.

In clinical studies, the Zevalin therapeutic regimen results in a significant radiation dose to the testes: the radiation dose to the ovaries has not been established [ see Dosage and Administration ( 2.5 )]. There is a potential risk that the Zevalin therapeutic regimen could cause toxic effects on the male and female gonads. Effective contraceptive methods should be used during treatment and for up to 12 months following the Zevalin therapeutic regimen.

📄 Package Label / Principal Display Panel 10 words ▾

18. PRINCIPAL DISPLAY PANEL image-04 image-05 image-06 image-07 image-08 image-09

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

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Acrotech Biopharma Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Acrotech Biopharma Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 72893-0005-01 · Acrotech 72893-0016-02 · Acrotech →
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.