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ZYMFENTRA infliximab-dyyb Kit — NDC 72606-0025-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ZYMFENTRA infliximab-dyyb Kit — NDC 72606-025-12 (Billing 72606-0025-12)

by CELLTRION USA Inc. · 6 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET

This is a package of ZYMFENTRA infliximab-dyyb Kit from CELLTRION USA Inc., marketed since Mar 2024 and currently FDA-listed.

NDC 72606-0025-12
🏷️ FDA NDC (as labeled) 72606-025-12 billing pads the product segment with a zero
This package
Contains1 mL in 1 syringe * 1 mL in 1 packet Pack sizes12 compare ↓
Also priced by: Part D plans $3,209.91/unit — full pricing hub ↓
Product page 72606-0025-02 Also comes in: 1 mL 72606-025-01 1 mL 72606-025-05 1 mL 72606-025-09 2 kits 72606-025-02 2 kits 72606-025-06 2 kits 72606-025-10 4 kits 72606-025-03 4 kits 72606-025-07 4 kits 72606-025-11 6 kits 72606-025-04 6 kits 72606-025-08
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 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

⚠️
Other active recalls for Infliximab-dyyb (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 17, 2025 — cGMP Deviations: Product intended for quarantine was inadvertently distributed. (McKesson) · FDA recall D-0213-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72606-025-12
Product NDC 72606-025
11-digit billing NDC 72606002512
RxCUI 797544, 2675742, 2675749, 2675753, 2675757
UNII B72HH48FLU
Application # BLA761358
SPL Set ID 93a193ab-9f96-4da6-aa7c-31212e81879a
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-01
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GCN Seq No 085585
GCN 55098
HICL code 043249
Ingredient (HICL) Infliximab-Dyyb
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2J
Therapeutic class — specific (HIC3) Anti-Inflammatory Tumor Necrosis Factor Inhibitor
AHFS code 90:24.16.92
AHFS class Tumor Necrosis Factor Inhibitors, Misc
FDB label name ZYMFENTRA 120 MG/ML SYRINGE KT
FDB brand name Zymfentra
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085585
  • GCN: 55098
  • HICL (First Databank): 043249
  • AHFS class code: 90:24.16.92
  • RxCUI (RxNorm): 797544
Why two NDCs? The FDA registers this code as 72606-025-12 — 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 → 72606-0025-12. 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 Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants
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 ZYMFENTRA 120 MG/ML SYRINGE KT Ingredient Infliximab-Dyyb
📗 Our plain-language guide HelloPharmacist
  • It treats inflammatory conditions including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Which one a...
  • You get it as a slow IV infusion lasting at least 2 hours at a medical setting. You'll usually have the first few doses at weeks 0, 2 and 6, then regular doses after that. Your car...
  • Common ones are colds and sinus infections, headache, stomach pain and reactions during the infusion such as flushing, rash or shortness of breath. You may get pre-medicines to hel...
  • Call right away for fever, chills, a cough that won't go away or other signs of infection. Also call for yellow skin or eyes, new heart failure symptoms, unusual bleeding or bruisi...
📖 Read our full Infliximab Injection guide →
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 · Q2 2026 $3,209.91 —
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
72606-0025-01 72606-025-01 1 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-02 72606-025-02 Main listing 2 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-03 72606-025-03 4 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-04 72606-025-04 6 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-05 72606-025-05 1 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-06 72606-025-06 2 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-07 72606-025-07 4 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-08 72606-025-08 6 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-09 72606-025-09 1 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-10 72606-025-10 2 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-11 72606-025-11 4 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active
72606-0025-12 You're viewing this 6 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 2024-03-01 — Active

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

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 6 kit in 1 carton / 1 kit in 1 kit * 1 syringe in 1 tray / 1 ml in 1 syringe * 1 ml in 1 packet.
What NDC number is used to bill for this package of ZYMFENTRA infliximab-dyyb Kit?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zymfentrathis 72606-0025-12 CELLTRION 6 kits — — 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

🏛️
2023
First FDA approval
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
2026
Biosimilars listed
4 FDA-licensed
🧬FDA-licensed biosimilars listed

4 biosimilars are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

🛡️ Latest patent/protection date listed: Biosimilars are already FDA-licensed for this product — the last listed patent runs to Oct 2035.
📅 FDA approved Oct 20, 2023

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Remicadeinfliximab Zymfentrainfliximab-dyyb
Biosimilars 4
Avsolainfliximab-axxq Inflectrainfliximab-dyyb Ixifiinfliximab-qbtx Renflexisinfliximab-abda
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2023 2025 2027 2029 2031 2033 2035
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateOct 20, 2035
Common questions
Is there a biosimilar for ZYMFENTRA 120 MG/ML SYRINGE KT?
Yes — at least one FDA-licensed biosimilar is listed for this biologic. See the Purple Book family above for the available products.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
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.

The FDA label contains product information, but this exact NDC could not be matched safely to one product block. We intentionally withheld sibling strengths’ 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

LabelerCELLTRION USA Inc.
FDA applicationBLA761358 (BLA)
Labeler code72606
First marketedMar 2024
Product typeHuman Prescription Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as hitoplasmosis) and infections due to ohter opportunistic pathogens. (5.1) Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. (5.1) Perform test for latent TB; if positive, start treatment for TB prior to starting ZYMFENTRA.

Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. (5.2) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products.

Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. (5.2 ) SERIOUS INFECTIONS Patients treated with TNF blockers, inculding ZYMFENTRA, are at increased risk for developing serious infections that may lead to hospitalization or death [ see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ) ].

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis.

Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patientsfor latent tuberculosis before ZYMFENTRA use and during therapy. Initiate treatment for latent infection prior to ZYMFENTRA use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with ZYMFENTRA prior to initiating therapy in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symtoms of infection during and after treatment with ZYMFENTRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products [ see Warnings and Precautions ( 5.2 ) ]. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products.

These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in young adult males. [ see Use in Specific Population ( 8.4 ) ].

🎯 Indications and Usage 89 words ▾

1 INDICATIONS AND USAGE ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. ( 1 ) moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ( 1 ) ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn's disease following treatment with an infliximab product administered intravetnously.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Important Dosage Information. ( 2.1 ). ZYMFENTRA is indicated as maintenance treatment only, starting at Week 10 and thereafter. ▫ All pateitns must complete an intravenous induction regiemen with an infliximab product before starting ZYMFENTRA.

ZYMFENTRA is for subcutaneous use only. Recommeneded Maintenance Dosage in Ulcerative Colitis and Crohn's Direase ( 2.2 ) Week 10 and thereafter : Inject 120 mg subcutaneously once every two weeks. To swift patients who are responding to maintenance therapy with an infliximab product administered intravenously, administer the first subcutaneous dose of ZYMFENTRA in place of the next scheduled intravenous infusion and every two weeks thereafter.

See the full prescribing information on how to administer subcutaneously. ( 2.3 )

2.1Important Dosage Information ZYMFENTRA is indicated as maintenance treatment only, starting at Week 10 and thereafter. ▫ All patients mush coplete an intravenous induction regimen with an infliximab product before starting ZYMFENTRA. For induction dosing information, see the corresponding full prescribing information for the chosen infliximab product. ZYMFENTRA is for subtutaneous use only.

2.2Recommeneded Dosage for Maintenance Treatment in Ulcerative Colitis Crohn's Disease Maintenance dosage starting at Week 10 and thereafter: 120 mg subcutaneously once every two weeks. To switch patients who are responding to maintenance therapy with an infliximab product administered intravenously, administer the first subcutaneous dose of ZYMFNETRA in place of the next scheuled intravenous infusion and every two weeks thereafter.

2.3Subcutaenous Administration Instructions ZYMFENTRA is intended for use under the guidance and supervision of a healthcare professional. If a healthcare professional determines that it is appropriate, patients may self-injection ZYMFENTRA or caregivers may injection ZYMFENTRA using either the ZYMFENTRA prefilled syringe, ZYMFENTRA prefilled syringe with needle guard, or ZYMFENTRA prefilled pen after proper training in subcutaenous injection technique. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whether solution and container permit.

ZYMFENTRA should be a clear, colorless to pale brwon solution. Do not use if particulates or discoloration is presnet. Inject into the front of the tights, the abdomen excepts for the 2 inches around the navel, or the outer area of the upper arms (caregiver only).

Rotate the injectoin site each time an inejction is given. Allow at least 1.2 inches between the new injection site and the previous inejction site. Never inject into areas where the skin is red, bruised, tender, or indurated.

Do not use the syringe or pen of it has been dropped or is visibly damaged. A damaged syringe may not function proprely. Do not resue or shake the syringe or pen at any time.

Mixed Dose If an injection of ZYMFENTRA is missed, inject the next subcutaneous dose as soon as possible and then every two weeks thereafter.

💊 Dosage Forms and Strengths 73 words ▾

3 DOSAGE FORMS AND STRENGTHS ZYMFENTRA (infliximab-dyyb) is a clear, colorless to pale brown solution available as follow: Injection: 120 mg/mL in a single-dose prefilled syringe. Injection: 120 mg/mL in a single-dose prefilled syringe with needle guard. Injection: 120 mg/mL in a single-dose prefilled pen.

Injection ( 3 ): 120 mg/mL in a single-dose prefilled syringe. 120 mg/mL in a single-dose prefilled syringe with needle guard. 120 mg/mL in a single-dose prefilled pen.

⛔ Contraindications 69 words ▾

4 CONTRAINDICATIONS ZYMFENTRA is contraindicated in patients with a history of a severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients in ZYMFENTRA, or any murine proteins. Reactions have included anaphylaxis [ see Warnings and Precautions ( 5.7 ) ]. History of severe hypersentitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients in ZYMFENTRA or to any murine proteins.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious injections, including invasive fungal infections: Avoid use of ZYMFENTRA in patients with an active infection. If infection develops during treatment, conduct a prompt and complete diagnostic workup appropriate for an immunocompromised patient and initiate antimicrobial therapy. If systemic illness develops in patients who reside or travel to regions where mycoses are endemic, consider empiric antifungal therapy.

( 5.1 ) Malignancies : The incidence of malignancies, including lymphoma, was greater in TNF blocker-treated patients than in controls. Consider the higher risk of hepatosplenic T-cell lymphoma (HSTCL) with combination therapy versus increased tisk of immunogenicity and hypersensitivity reactions with monotherapy. ( 5.2 ) Hepatitis B virus (HBV) reactivation: Test for HBV infection before starting ZYMFENTRA.

Monitor HBV carriers during and several months after therapy for active HBV infection. If reactivation occurs, stop ZYMFENTRA and begin anti-viral therapy. ( 5.3 ) Hepatotoxicity: Severe hepatic reactions, some fatal or necessitating liver transplantation with infliximab products.

Monitor hepatic enzymes and liver function tests every 3 to 4 months during treatment; investigate liver enzyme elevations and interrupt treatment if drug-induced liver injury is suspected. Instruct patients to seek immediate medical attention if symptoms develop. ( 5.4 ) Congestive heart failure (CHF) : New onset or worsening symptoms may occur.

Avoid ZYMFENTRA in patients with CHF. Monitor for new or worsening symptoms if a decision is made to administer ZYMFENTRA. ( 5.5 ) Hematologic Reactions : Advise patients to seek immediate medical attention if signs and symtoms of cytopenia develop; consider stopping ZYMFENTRA if significant hematologic abnormalities devlop.

( 5.6 ) Hypersensitivity and Other Administration Reactions : Serious systemic hypersensitivity reactions including anaphylaxis; institute appropriate therapy and discontinue ZYMFENTRA. ( 4 , 5.7 ) Neurologic Reactions : Exacerbation or new onset CNS demyelinating disorders may occurs; consider discontinuation of ZYMFENTRA. ( 5.8 ) Risk of infection with concurrent administration of other biological products : Concurrent use with other immunosuppressive biological products may increase the risk of injection ( 5.9 ) Risk of additive immunosuppressive effects from prior biologic products : Consider the half-life and mode of action of prior biological products.

( 5.10 ) Autoimmunity : Formation of autoantibodies and development of lupus-like syndrome may occur; discontinue ZYMFENTRA if symptoms develop. ( 5.11 ) V accinations and Use of Live Vaccines/Therapeutic Infectious Agents: Prior to initiating ZYMFENTRA bring patients up to date with all vaccinations. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA.

A 6-month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab products. ( 5.12 )

5.1Serious Infections Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, cryptococcosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, salmonellosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.

Treatment with ZYMFENTRA should not be initiated in patients with an active infection, including clinically important localized infections.Patients greater than 65 years of age, patients with comorbid-conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. The risks and benef… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious infections [ see Warnings and Precautions ( 5.1 ) ] Malignancies [ see Warnings and Precautions ( 5.2 ) ] Hepatitis B virus reactivation [ see Warnings and Precautions ( 5.3 ) ] Hepatotoxicity [ see Warning and Precautions ( 5.4 ) ] Congestive heart failure [ see Warnings and Precautions ( 5.5 ) ] Hematologic reactions [ see Warnings and Precautions ( 5.6 ) ] Hypersensitivity and other administration reactions [ see Warnings and Precautions ( 5.7 ) ] Neruologic reactions [ see Warnings and Precautions ( 5.8 ) ] Autoimmunity [ see Warnings and Precautions ( 5.11 ) ] Most common adverse reactions (>3%) are: Ulcerative Colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain.

( 6.1 ) Crohn's Disease: COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness, and leukopenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. at 1-800-560-9414 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 data described below reflect exposure to ZYMFENTRA in 518 adult subjects in two 54-weekrandomized, double-blind, placebo-controlled trials in subjects with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD) (UC Trial I an CD Trial I).

Subject who achieved clinical response following three induction doses of infliximab-dyyb administered as an intravenous infusion at Week 0, 2 and 6 were randomized 2:1 to ZYMFENTRA 120 mg or placebo as a subcutaneous injection every two weeks at Week 10 [ see Clinical Studies ( 14.1 and 14.2 )]. Ulcerative Colitis The most common adverse reactions reported in ≥3% of subjects and at a higher rate than Placebo in UC Trial I are shown in Table 1. Table 1 Adverse Reactions a in the Maintenance Phase of a Randomized, Double-Blind 54-Week Study of Subjects with UC (UC Tral I) ZYMFENTRA 120 mg Subcutaneous Injection b N=296 (%) Placebo N=140 (%) COVID-19 10 6 Anemia d 5 4 Arthralgia 4 1 Injection site reaction # 3 2 Increased alanine aminotransferase 3 1 Abominal pain f 3 1 a reported in at least 3% of ZYMFENTRA-treated subjects and at a higher than placebo b ZYMFENTRA 120 mg as a subcutaneous injection every two weeks starting Week 10 following 3 intravenous induction doses of inflixiab-dyyb c Includes: COVID-19 and COVID-19 pneumonia d Includes: anemia and iron deficiency anemia # Some subjects had multiple occurences of injection site reactions.

In this table, injection site reactions are counted only once per subject. Symptoms in individual subjects included one or more of injection site bruising, edema, erythema, induration, pain, pruritus and swelling. f Includes: abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort Crohn's Disease The most common adverse reactions reported in ≥3% of subjects and at a higher rate than placebo in CD Trial I are shown in Table 2. Table 2 Adverse Reactions a in the Maintenance Phase of a Randomized, Double-Blind 54-Week Study of Subjects with CD (CD Trial I) ZYMFENTRA 120 mg Subcutaneous Injection b N=222 (%) Placebo N=101 (%) COVID-19 10 5 Headache 8 4 Upper respiratory track infectionsd c 7 3 Injection site reaction d 5 1 Diarrhea 5 1 Increased blood creatine phosphokinase 4 2 Arthralgia 4 3 Increased alaine aninotransferase 4 1 Hypertensions e 3 2 Urinary track infection f 3 2 Neutropenia 3 0 Dizziness 3 0 Leukopenia 3 0 a reported in at least… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Other Biological Products Used to Treat UC and CD The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended [ see Warnings and Precautions ( 5.9 ) ]. Consier the half-life and mode of action of prior biologial products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA [ see Warnings and Precautions ( 5.10 ) ].

7.2Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Therefore, ZYMFENTRA, an antagonist of TNFα, could normalize the formation of CYP450 enzymes potentially resulting in a decrease in exposure of CYP450 substrates. Upon initiation or discontinuation of TNF blockers, including ZYMFENTRA, in patients being treated with CYP450 substrates requiring therapeutic drug monitoring, monitor therpeutic parameters (e.g., INR for warfarin) or drug concentration (e.g., cyclosporine or theophylline).

Dosage adjustment may be needed to maintain drug concentrations or parameters within the therapeutic range. See prescribing information for specific drugs.

7.3Live Vaccines/Therapeutic Infectious Agents It is recommended that live vaccines not be given concurrently with ZYMFENTRA. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab products for 6 months following birth [ see Warnings and Precautions ( 5.12 ) ]. It is recommended that therapeutic infectious agents not be given concurrently with ZYMFENTRA [ see Warnings and Precautions ( 5.12 ) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from reports of pregnancy in clinical trials with ZYMFENTRA are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy ( see Clinical Considerations ). Available observational data in pregnant women exposed to infliximab products administered intravenously showed no increased risk of major malformations among live births as compared to those exposed to non-biologics.

Most TNF blockers, such as infliximab products, administered intravenously are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. Infants exposed in utero should not be administered live vaccines for at least 6 months after birth ( see Clinical Considerations ). Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA.

The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

Clinical Consideration Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that there is an increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth. Fetal/Neonatal Adverse Reactions The risk of fetal/neonatal adverse reactions with in utero exposure to infliximab-dyyb administered subcutaneously is unknown.

However, most TNF blockers, such as infliximab products, cross the placenta and have been detected in infant serum up to 6 months following birth. Consequently, infants exposed to infliximab products may be at increased risk of infection, including disseminated infection which can become fatal. At least a six-month waiting period following birth is recommended before the administration of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus vaccine) to infants exposed to intravenous infliximab in utero [ see Warnings and Precautions (5.12) ].

Cases of agranulocytosis in infants exposed to intravenous infliximab in utero have also been reported. Therefore, ZYMFENTRA, administered during pregnancy may affect immune responses in the in utero-exposed newborn and infant [ see Adverse Reactions 6.2 ]. Data Animal Data Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA.

8.2Lactation Risk Summary There are no data on the presence of infliximab-dyyb or its metabolites in either human or animal milk, the effects on the breastfed infant, or the effects on milk production after subcutaneous administration. Published literature show that infliximab is present at low levels in human milk after intravenous administration. Systemic exposure in a breastfed infant is expected to be low because infliximab products are largely degraded in the gastrointestinal tract.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZYMFNETRA and any potential adverse effects on the brestfed child from ZYMFENTRA or from the underlying maternal condition.

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

8.5Geriatirc Use Clinical trials of ZYMFENTRA did not include sufficient numbe… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from reports of pregnancy in clinical trials with ZYMFENTRA are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy ( see Clinical Considerations ). Available observational data in pregnant women exposed to infliximab products administered intravenously showed no increased risk of major malformations among live births as compared to those exposed to non-biologics.

Most TNF blockers, such as infliximab products, administered intravenously are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. Infants exposed in utero should not be administered live vaccines for at least 6 months after birth ( see Clinical Considerations ). Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA.

The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

Clinical Consideration Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that there is an increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth. Fetal/Neonatal Adverse Reactions The risk of fetal/neonatal adverse reactions with in utero exposure to infliximab-dyyb administered subcutaneously is unknown.

However, most TNF blockers, such as infliximab products, cross the placenta and have been detected in infant serum up to 6 months following birth. Consequently, infants exposed to infliximab products may be at increased risk of infection, including disseminated infection which can become fatal. At least a six-month waiting period following birth is recommended before the administration of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus vaccine) to infants exposed to intravenous infliximab in utero [ see Warnings and Precautions (5.12) ].

Cases of agranulocytosis in infants exposed to intravenous infliximab in utero have also been reported. Therefore, ZYMFENTRA, administered during pregnancy may affect immune responses in the in utero-exposed newborn and infant [ see Adverse Reactions 6.2 ]. Data Animal Data Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA.

🧒 Pediatric Use 14 words ▾

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

🧓 Geriatric Use 36 words ▾

8.5Geriatirc Use Clinical trials of ZYMFENTRA did not include sufficient numbers of sugjects aged 65 and over (8 subjects with UC and 6 subjects with CD) to determined whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHAMACOLOGY

12.1Mechanism of Action Infliximab-dyyb neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. Infliximab-dyyb has shown biological activities, such as TNFα neutralization activity and TNFα binding affinities, complement 1q (C1q) binding affinity and crystallizable fragment (Fc) receptor binding affinities in a wide variety of in vitro bioasays. The relationship of these biological response markers to the mechanism(s) by which infliximab-dyyb exerts its clinical effects is unknown.

12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted.

12.3Phamacokinetics Following single and multiple subcutaneous dosing of infliximab-dyyb, exposures to infliximab-dyyb (i.e., AUC) are proportionally increased over the dose range from 120 mg to 240 mg (2 times the recommended dosage). After a single subcutaneous dose of infliximab-dyyb 120 mg in healthy subjects, the median (SD) C max and AUC inf were 10.0 (3.2) mcg/mL and 6945.6 (2830.2) mcg·h/mL, respectively. Following recommended subcutaneous maintenance dose of ZYMFENTRA (120 mg every 2 weeks) in adult subjects with UC and CD from Week 10 after intravenous induction treatment with infliximab-dyyb, steady-state was achieved by Week 22, and the mean (SD) trough serum concentrations of infliximab-dyyb at steady-state were 14.6 (7.8) mcg/mL and 14.6 (8.9) mcg/mL in subjects with UC and CD, respectively.

Pharmacokinetics are comparable between healthy subjects, and subjects with UC or CD. Absorption In healthy subjects, the median time to reach the maximum serum concentration (T max ) was 7 days after a single subcutaneous dose of infliximab-dyyb 120 mg. In healthy subjects, AUC inf following a single subcutaneous dosed of infliximab-dyyb 120 mg was approximately 23% relative to a single intravenous dose of infliximab-dyyb 5 mg/kg.

Following infliximab-dyyb 120 mg subcuaneosly every 2 weeks, steady state AUC for 8-week internal was 25-35% higher compared to infliximab-dyyb 5 mg/kg administered intravenously every 8 weeks in subjects with UC and CD. Distribution Population pharmacokinetic analyses showed that the volume of distribution of infliximab-dyyb was 3.36L. Elimination In healthy subjects, the mean half-life was 332 hours after a single subcutaneous dose of infliximab-dyyb 120 mg.

Populatoin pharmacokinetic analyses showed that the clearance of infliximab-dyyb was 0.013 L/hr and the clearance was increased in the presence of anti-drug antibody. The metabolic pathway of infliximab has not been characterized. As a IgG1κ monoclonal antibody, infliximab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.

Specific Populations Weight Population pharmacokinetic analysis indicated that exposure to infliximab-dyyb was inversely related to body weight. However, the magnitude of body weight effect on systemic exposure was not clinically meaningful in adult subjects with UC and CD weighing from 39 to 130 kg. Age, Sex and Race Age (≥65 years ofld), sex, or race did not have a clinically meaningful effect on pharmacokinetics of infliximab-dyyb.

Drug Interaction Studies Population pharmacokinetic analysis showed that co-administered methotrexate did not have clinically meaningful effect on the pharmacokinetics of infliximab-dyyb.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Difference in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of infliximab-dyyb or of other infliximab products. In UC and CD clinical studies (UC Trial I and CD Trial I), approximately 64% subjects developed anti-drug antibodies to infliximab-dyyb following induction t… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 85 words ▾

12.1Mechanism of Action Infliximab-dyyb neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. Infliximab-dyyb has shown biological activities, such as TNFα neutralization activity and TNFα binding affinities, complement 1q (C1q) binding affinity and crystallizable fragment (Fc) receptor binding affinities in a wide variety of in vitro bioasays. The relationship of these biological response markers to the mechanism(s) by which infliximab-dyyb exerts its clinical effects is unknown.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZYMFENTRA (Infliximab-dyyb) injection for subcutaneous use is supplied as a sterile, preservative-free, clear to opalescent, colorless to pale brown solution in a single-use prefilled syringe, prefilled syringe with needle guard or prefilled pen. The syringe is fitted with a needle shield which are not made with natural rubber latex or any derivatives from natural rubber latex in any ingredient. Prefilled Syringe Each prefilled syringe is equipped with a 29 gauge fixed 1/2 inch needle with a rigid needle shield and a plunger stopper.

The following configurations are available: One prefilled syringe (120 mg/mL solution) and one dose tray with two alcohol pads. (NDC: 72606-025-05) Two prefilled syringes (120 mg/mL solution) and two dose trays with two alcohol pads. (NDC: 72606-025-06) Four prefilled syringes (120 mg/mL solution) and four dose trays with four alcohol pads.

(NDC: 72606-025-07) Six prefilled syringes (120 mg/mL solution) and six dose trays with six alcohol pads. (NDC: 72606-025-08) Prefilled Syringe with Needle Guard Each prefilled syringe is equipped with a 29 gauge fixed 1/2 inch needle with a rigid needle shield and an automatic needle guard, and a plunger stopper. The following configurations are available: One prefilled syringe with needle guard (120 mg/mL solution) and one does tray with two alcohol pads.

(NDC: 72606-025-09) Two prefilled syringes with needle guard (120 mg/mL solution) and two dose trays with two alcohol pads. (NDC: 72606-025-10) Four prefilled syringes with needle guard (120 mg/mL solution) and four dose trays with four alcohol pads. (NDC: 72606-025-11) Six prefilled syringes with needle guard (120 mg/mL solution) and six dose trays with six alcohol pads.

(NDC: 72606-025-12) Prefilled Pen Each prefilled pen is equipped with a 27 gauge fixed 1/2 inch needle with a rigid needle shield and a plunger stopper. The following configurations are available: One prefilled pen (120 mg/mL solution) and one dose tray with two alcohol pads. (NDC: 72606-025-01) Two prefilled pens (120 mg/mL solution and two dose trays with two alcohol pads.

(NDC: 72606-025-02) Four prefilled pens (120 mg/mL solution) and four dose trays with four alcohol pads. (NDC: 72606-025-03) Six prefilled pens (120 mg/mL solution) and six dose trays with six alcohol pads. (NDC: 72606-025-04) Storage and Handling Store in refrigerator at 2°C to 8°C (36°F to 46°F).

DO NOT FREEZE. Keep the product in its outer carton until time of administration in order to protect from light. If needed, the product may be stored at room temperature at 20°C to 25°C (68°F to 77°F) for up to 14 days with protection from light.

Once the product has been stored at room temperature, it should not be placed back into the refrigerator. The product must be discarded if not used within the 14 days.

📋 Description 130 words ▾

11 DESCRIPTION Infliximab-dyyb, a tumor necrosis factor (TNF) blocker, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions). It has a molecular weight of approximately 145.9 kDa. Infliximab-dyyb is produced by a recombinant murine myeloma cell line, SP2/0.

ZYMFENTRA (inifliximab-dyyb) injection for subcutaneous use is a sterile, preservative-free, clear to opalescent, colorless to pale brown solution. ZYMFENTRA is supplied in a single-dose prefilled syringe with 29 gauge fixed 1/2 inch needle, prefilled syringe with 29 gauge fixed 1/2 inch needle with needle guard, or prefilled pen with 27 gauge fixed 1/2 inch needle. Each mL of solution contains 120 mg infliximab-dyyb, acetic acid (0.19 mg), polysorbate 80 (0.5 mg), sodium acetate (0.56 mg), sorbitol (45 mg) and Water for Injection, USP.

The pH is 5.0.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or thier caregiver to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use). Patients or their caregivers should be advised of the potential benefits and risks of ZYMFENTRA. Healthcare providers should instruct their patients or their caregivers to read the Medication Guide before starting ZYMFENTRA therapy and to reread it each time they receive an injection.

Infections Inform patients that ZYMFENTRA increases the risk for developing serious infections. Instruct patients of the importance of contacting their healthcare provider if they develop any symptoms of an infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [ see Warnings and Precautions ( 5.1 , 5.3 ) ]. Malignancies Malignancies have been reported among children, adolescents and young adults who received treatment with TNF blockers.

Patients should be counseled about the risk of lymphoma and other malignancies while receiving ZYMFENTRA [ see Warnings and Precautions ( 5.2 ) ]. Hepatotoxicity Instruct patients to seek medical attention if they develop signs or symptoms of hepatotoxicity (e.g., jaundice) [ see Warnings and Precautions ( 5.4 ) ]. Congestive Heart Failure Instruct patients to seek medical attention and consult their prescriber if they develop signs or symptoms of heart failure [ see Warnings and Precautions ( 5.5 ) ].

Hematologic Reactions Instruct patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on ZYMFENTRA [ see Warnings and Precautions ( 5.6 ) ]. Hypersensitivity Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [ see Warnings and Precautions ( 5.7 ) ]. Neurologic Reactions Advise patients to seek medical attention if they develop signs or symptoms of neurologic reactions [ see Warnings and Precautions ( 5.8 ) ].

Live Vaccines/Therapeutic Infectious Agents Instruct ZYMFENTRA-treated patients to avoid receiving live vaccines or therapeutic infectious agents [ see Warnings and Precautions ( 5.12 ) ] Administration Instruct patients to follow sharp disposal recommendations, as described in the Instructions for Use.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 02/2024 MEDICATION GUIDE ZYMFENTRA TM (Zim fen' trah) (infliximab-dyyb) injection, for subcutaneous use Read the Medication Guide that comes with ZYMFENTRA before you receive the first treatment, and before each time you receive a treatment of ZYMFENTRA. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about ZYMFENTRA ? ZYMFENTRA may cause serious side effects, including: 1. Risk of infection ZYMFENTRA is a medicine that affects your immune system.

ZYMFENTRA can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving ZYMFENTRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body.

Some patients have died from these infections. Your doctor should test you for TB before starting ZYMFENTRA. Your doctor should monitor you closely for signs and symptoms of TB during treatment with ZYMFENTRA.

Before starting ZYMFENTRA, tell your doctor if you: think you have an infection. You should not start receiving ZYMFENTRA if you have any kind of infection. are being treated for an infection. have signs of an infection, such as a fever, cough, flu-like symptoms. have any open cuts or sores on your body. get a lot of infections or have infections that keep coming back. have diabetes or an immune system problem as people with these conditions have a higher chance for getting infections. have TB, or have been in close contact with someone with TB. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis); these infections may develop or become more severe if you receive ZYMFENTRA.

If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor. have or have had hepatitis B. use the medicines KINERET (anakinra), ORENCIA (abatacept), or other medicines called biologics used to treat the same conditions as ZYMFENTRA. After starting ZYMFENTRA, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. ZYMFENTRA can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor (TNF) blocker medicines, such as ZYMFENTRA. For people receiving TNF blocker medicines, including ZYMFENTRA, the chances of getting lymphoma or other cancers may increase.

Some people receiving TNF blockers, including ZYMFENTRA, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men.

Also, most people were being treated for Crohn's disease or ulcerative colitis with a TNF blocker and another medicine called azathioprine or 6-mercaptopurine. People who have been treated for Crohn's disease and ulcerative colitis, for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.

Some people treated with infliximab products, such as ZYMFENTRA, have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with ZYMFENTRA, tell your doctor. Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with ZYMFENTRA.

Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Phamacokinetics Following single and multiple subcutaneous dosing of infliximab-dyyb, exposures to infliximab-dyyb (i.e., AUC) are proportionally increased over the dose range from 120 mg to 240 mg (2 times the recommended dosage). After a single subcutaneous dose of infliximab-dyyb 120 mg in healthy subjects, the median (SD) C max and AUC inf were 10.0 (3.2) mcg/mL and 6945.6 (2830.2) mcg·h/mL, respectively. Following recommended subcutaneous maintenance dose of ZYMFENTRA (120 mg every 2 weeks) in adult subjects with UC and CD from Week 10 after intravenous induction treatment with infliximab-dyyb, steady-state was achieved by Week 22, and the mean (SD) trough serum concentrations of infliximab-dyyb at steady-state were 14.6 (7.8) mcg/mL and 14.6 (8.9) mcg/mL in subjects with UC and CD, respectively.

Pharmacokinetics are comparable between healthy subjects, and subjects with UC or CD. Absorption In healthy subjects, the median time to reach the maximum serum concentration (T max ) was 7 days after a single subcutaneous dose of infliximab-dyyb 120 mg. In healthy subjects, AUC inf following a single subcutaneous dosed of infliximab-dyyb 120 mg was approximately 23% relative to a single intravenous dose of infliximab-dyyb 5 mg/kg.

Following infliximab-dyyb 120 mg subcuaneosly every 2 weeks, steady state AUC for 8-week internal was 25-35% higher compared to infliximab-dyyb 5 mg/kg administered intravenously every 8 weeks in subjects with UC and CD. Distribution Population pharmacokinetic analyses showed that the volume of distribution of infliximab-dyyb was 3.36L. Elimination In healthy subjects, the mean half-life was 332 hours after a single subcutaneous dose of infliximab-dyyb 120 mg.

Populatoin pharmacokinetic analyses showed that the clearance of infliximab-dyyb was 0.013 L/hr and the clearance was increased in the presence of anti-drug antibody. The metabolic pathway of infliximab has not been characterized. As a IgG1κ monoclonal antibody, infliximab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.

Specific Populations Weight Population pharmacokinetic analysis indicated that exposure to infliximab-dyyb was inversely related to body weight. However, the magnitude of body weight effect on systemic exposure was not clinically meaningful in adult subjects with UC and CD weighing from 39 to 130 kg. Age, Sex and Race Age (≥65 years ofld), sex, or race did not have a clinically meaningful effect on pharmacokinetics of infliximab-dyyb.

Drug Interaction Studies Population pharmacokinetic analysis showed that co-administered methotrexate did not have clinically meaningful effect on the pharmacokinetics of infliximab-dyyb.

🧬 Pharmacodynamics 9 words ▾

12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adult Ulcerative Colitis The safety and efficacy of ZYMFENTRA were assessed in a randomized, double-blind, placebo-controlled clinical trial (UC Trial I; NCT04205643 ) in adult subjects with moderately to severely active UC (defined as a modified Mayo score [mMS] between 5 to 9 with an endoscopic subscore [ES] of 2 or 3). The mMS is a 3-component Mayo score (0-9), which consists of following subscores (0 to 3 for each subscore): stool frequency (SFS), rectal bleeding (RBS), and findings on centrally read endoscopy score (ES).

An ES of 2 was defined by marked erythema, lack of vascular pattern, any friability, and/or erosions, and a score of 3 was defined by spontaneous bleeding and ulceration. Subjects had demonstrated an inadequate response or intolerance to treatment with corticosteroids alone or in combination with 6-mercaptopurine or azathioprine. Subjects were permitted to use stable doses of oral aminosalicylates, oral corticosteroids (prednisone ≤20 mg/day or equivalent, budesonide ≤9 mg/day), UC-related antibiotics, and/or immunomodulatory agents (azathioprine, 6-mercaptopurine, or methotrexate).

Corticosteroid tapering was permitted after Week 10. All subjects received three intravenous induction doses of 5 mg/kg of infliximab-dyyb at Weeks 0, 2 and 6. In order to be randomized to treatment in UC Trial I, subjects had to be in clinical response at Week 10.

Clinical response was defined as a decrease from baseline in the mMS of at least 2 points and at least 30%, with an accompanying decrease in the RBS of at least 1 point or an aabsolute RBS of 0 or 1 point. A total of 438 subjects were randomized at Week 10 in a double-blind fashion (2:1) to ZYMFENTRA 120 mg as a subcutaneous injection or placebo every two weeks. At the time of randomization into the double-blind phase (Week 10), 92% were receiving aminosalicylates, 41% were receiving oral corticosteroids, and 22% were receiving immunomodulators including AZA, 6-MP or MTX.

A total of 10% of randomized subjects had prior exposure to biological poucts or JAK inhibitors. Subjects in the boule-blind phase had a mean age of 39 years (range 18 to 75 years); 44% were female; and 98% identified as White, and 2% as American Indian or Alaska Native. The primary endpoint was the proportion of subjects in clinical remission at Week 54.

Wecondary endpoints included the proportion of subjects achieving histologic-endoscopic mucosal improvement and corticosteroid-fee remission at Week 54 (see Table 3 ). Table 3: Proportion of Subjects with Ulcerative Colitis Meeting Effficacy Endpoints at Week 54 in UC Trial I Endpoint ZYMFENTRA Placebo Treatment Difference a and 95% CI Clinical Remission b at Week 54 Total population N=294 43% N=144 21% 21% (12, 29) No prior biological product/JAK inhibitor exposure N=265 45% N=131 21% Prior biological product/JAK inhibitor exposure N=29 31% N=13 15% Histologic-Endoscopic Mucosal Improvement d at Week 54 Total population N=294 36% N=144 17% 18% (9, 26) No prior biological product/JAK inhibitor exposure N=265 36% N=131 18% Prior biological product/JAK inhibitor exposure N=29 31% N=13 8% Corticosteroid-Fee Remission e at Week 54 Total population N=120 37% N=61 18% 17% f (3, 29) No prior biological product/JAK inhibitor N=107 36% N=56 18% Prior biological product/JAK inhibitor exposure N=13 39% N=5 20% CI = confience interval, JAK = Janus kinase a Treatement difference (adjusted for stratification factors of previous exposure to biological product and/or JAK inhibitor, use of treatment with oral corticosteoids Week 0, and clinical remission status at Week 10.) b Clinical remissio is defined using the mMS as SFS of 0 or 1 point; RBS of 0 point; and ES of 0 or 1 point (excluding friability). c p < 0.0001 d Histologic-endoscopic mucosal improvement is defined as an absolute ES of 0 or 1 po int (excluding friability) from mMS and an absoluted Robarts Histopathology Index (RHI) score of ≤3 poitns with no lamina propria neutrophils… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 28 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies of infliximab-dyyb have not been conducted to evaluate the carcinogenic potential or its effect on fertility.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE ZYMFENTRA (Zim fen' trah) (infliximab-dyyb) Injection for subcutaneous use only Single-Dose Prefilled Pen 120 mg/mL Rx Only Read and follow the Instruction for Use that come with your ZYMFENTRA Prefilled Pen before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Figure A: Parts of ZYMFENTRA Prefilled Pen Important Information Use the Prefilled Pen only if your healthcare provider has trained you on the right way to prepare for and to give an injection. Ask your healthcare provider how often you will need to give an injection. Rotate the injection site each time you give an injection.

Each new injection site should be at least 1.2 inches away from the previous injection site. Do not shake the Prefilled Pen at any time. Do not remove the Cap until you are ready to inject.

Do not share the Prefilled Pen with anyone. How to store the Prefilled Pen Store the Prefilled Pen in a refrigerator between 36°F to 46°F (2°C to 8°C). Keep the Prefilled Pen in the original carton until use to protect it from light.

Do not use the Prefilled Pen that has been left in direct sunlight. Do not freeze the Prefilled Pen. If the Prefilled Pen has been frozen, do not use the Prefilled Pen even if it is thawed.

Do not warm the Prefilled Pen using heat sources such as hot water or a microwave. Let the Prefilled Pen naturally warm at room temperature between 68°F to 77°F (20°C to 25°C) for 30 minutes before giving an injection. When the Prefilled Pen has reached room temperature, do not put it back in the refrigerator.

The Prefilled Pen must be thrown away (discarded) if not used within the 14 days. Keep the Prefilled Pen and all medicines out of the reach of children. Prepare for the Injection 1.

Gather the supplies for the injection. 1a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.

1b. Remove 1 Prefilled Pen from the carton stored in your refrigerator. Note: Return the carton with any unused Prefilled Pens to refrigerator immediately after taking out one Prefilled Pen.

1c. Make sure you have the following supplies: - Prefilled Pen - 1 Alcohol swab Not included in the carton: - 1 Cotton ball or gauze - 1 Adhesive bandage - FDA-cleared sharps disposal container 2. Inspect the Prefilled Pen.

2a. Make sure you have the correct medicine (ZYMFENTRA). 2b.

Check the expiration (EXP) date on the label of the Prefilled Pen (See Figure B). 2c. Look at the Prefilled Pen and make sure it is not cracked or damaged.

Do not use the Prefilled Pen if: - it is cracked or damaged. - the expiration (EXP) date has passed. Figure B 3. Inspect the Medicine.

3a. Look through the Window and make sure that the liquid is clear, colorless to pale brown, and free of particles (see Figure C). Do not use the Prefilled Pen if the liquid is the discolored (yellow or dark brown), cloudy, or contains particles in it.

You may see air bubbles in the liquid. This is normal. Figure C 4.

Wait 30 minutes. 4a. Leave the Prefilled Pen at room temperature 68°F to 77°F (20°C to 25°C) for 30 minutes to allow it to warm up (see Figure D).

Do not warm the Prefilled Pen using heat sources such as hot water or a microwave. Figure D 5. Choose an injection site (see Figure E).

5a. You may inject into: - the front of your thighs. - the stomach area (abdomen) except for the 2 inches around the belly button (navel). - the outer area of the upper arm if you are a caregiver. Do not inject into skin that is within 2 inches of your belly button (navel), or is red, hard, tender, damaged, bruised, or scarred.

Do not inject through your clothes. 5b. Rotate the injection site each time you give an injection.

Do not inject the same injection site each time you give an injection. Each new injection site should be at least 1.2 inches away from the injection site you used before. Figure E 6.

Wash your han 6a.… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Pen Label NDC 72606-025-01 Rx only Zymfentra TM infliximab–dyyb injection Subcutaneous use CELLTRION Inc. PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Pen Label

PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Pen Carton Zymfentra TM infliximab-dyyb Injection 120 mg/mL FOR SUBCUTANEOUS USE ONLY ATTENTION: Disponse the enclosed Medication Guide to each patient. NDC 72606-025-01 Rx ony 1 prefilled pen + 2 alcohol preps 1 Single-Dose Prefilled Pen CELLTRION USA, Inc. PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Pen Carton

PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Syringe with Needle Guard Label NDC 72606-025-09 Rx only Zymfentra TM infliximab–dyyb injection Subcutaneous use CELLTRION, In c. PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Syringe with Needle Guard

PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Syringe with Needle Guard Carton Zymfentra TM infliximab-dyyb injection 120 mg/mL FOR SUBCUTANEOUS USE ONLY ATTENTION: Dispense the enclosed Medication Guide to each patient. NDC 72606-025-09 1 prefilled syringe with needle guard + 2 alcohol preps 1 Single-Dose Prefilled Syringe with Needle Guard CELLTRION USA, Inc. PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Syringe with Needle Guard

PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Syringe Label NDC 72606-025-05 Rx only Zymfentra TM infliximab–dyyb injection Subcutaneous use CELLTRION, Inc. PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Syringe Label

PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Syringe Carton Zymfentra TM infliximab-dyyb injection 120 mg/mL FOR SUBCUTANEOUS USE ONLY ATTENTION: Dispense the enclosed Medication Guide to each patient. NDC x72606-025-05 Rx 1 prefilled syringe + 2 alcohol preps 1 Single-Dose Prefilled Syringe CELLTRION USA, Inc. PRINCIPAL DISPLAY PANEL - 120 mg/mL Prefilled Syringe Carton

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
2 kits72606-0025-02 656 Rx · $4,669,836
1 kit72606-0025-01 488 Rx · $3,024,344
4 kits72606-0025-03 No Medicaid data
6 kits72606-0025-04 No Medicaid data
1 kit72606-0025-05 No Medicaid data
2 kits72606-0025-06 No Medicaid data
4 kits72606-0025-07 No Medicaid data
6 kits72606-0025-08 No Medicaid data
1 kit72606-0025-09 No Medicaid data
2 kits72606-0025-10 No Medicaid data
4 kits72606-0025-11 No Medicaid data
6 kits this page72606-0025-12 No Medicaid data
Drug total (last 4 qtrs): 1,144 Rx · 1,860 units · $7,694,180 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Zymfentra — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Zymfentra. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$183.3K
Claims incl. refills
25
Beneficiaries
11
Spend / beneficiary
$16,659.23
Spend / claim
$7,330.06
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 ✓ Available
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 CELLTRION USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 11 other package presentations of this same product, including 1 kit (72606-0025-01), 1 kit (72606-0025-05), 1 kit (72606-0025-09). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
CELLTRION USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 72606-0024-01 · CELLTRION 72606-0027-01 · CELLTRION →
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.