Home › NDC Lookup › Ingredients › Nadofaragene Firadenovec-Vncg › 55566-1050-01
ADSTILADRIN nadofaragene firadenovec-vncg 300000000000 {VP}/mL Suspension — NDC 55566-1050-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ADSTILADRIN nadofaragene firadenovec-vncg 300000000000 {VP}/mL Suspension — NDC 55566-1050-1 (Billing 55566-1050-01)

by Ferring Pharmaceuticals Inc. · 4 VIAL in 1 CARTON / 20 mL in 1 VIAL

This is a package of ADSTILADRIN nadofaragene firadenovec-vncg 300000000000 {VP}/mL Suspension from Ferring Pharmaceuticals Inc., marketed since Sep 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 55566-1050-01
🏷️ FDA NDC (as labeled) 55566-1050-1 billing pads the package segment with a zero
This package
Contains20 mL in 1 vial Pack sizes2 compare ↓
Main listing for product 55566-1050 · Also comes in: 20 ml 55566-1050-2
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 55566-1050-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
55566 labeler · 1050 product · 1 package
Package marketed since
Sep 5, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5556610501 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55566-1050-1
Product NDC 55566-1050
11-digit billing NDC 55566105001
NCPDP billing unit EA — each (per item)
RxCUI 2644440, 2644445
UNII 0OOS09O1FH
Application # BLA125700
SPL Set ID 5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-05
Route INTRAVESICAL
Dosage form SUSPENSION
Substance NADOFARAGENE FIRADENOVEC
Biologic (Purple Book) 351(a)

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

GPI-14 21540050401820
GCN Seq No 084204
GCN 53398
HICL code 048536
Ingredient (HICL) Nadofaragene Firadenovec-Vncg
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V5
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 2)
HIC3 code V5E
Therapeutic class — specific (HIC3) Antineoplastic - Gene Therapy Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ADSTILADRIN VIAL
FDB brand name Adstiladrin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084204
  • GCN: 53398
  • GPI-14 (Medi-Span): 21540050401820
  • HICL (First Databank): 048536
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2644440
Why two NDCs? The FDA registers this code as 55566-1050-1 — a 5-4-1 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 package segment → 55566-1050-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antineoplastic cell and gene therapy class.

Drug family (ATC) Antineoplastic cell and gene therapy
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 ADSTILADRIN VIAL Ingredient Nadofaragene Firadenovec-Vncg

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9029 $64,331.614 / J9029 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)55566-1050-1
11-digit billing NDC55566-1050-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ9029
DescriptorInjection, nadofaragene firadenovec-vncg, per therapeutic dose
Billing units / pkg1 units
How the units are derivedThis package is 20; the HCPCS unit is Per Therapeutic Dose, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$31,331,221 · 497 claims · $63,040.69 per claim (all NDCs under J9029)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55566-1050-01 You're viewing this Main listing 4 VIAL in 1 CARTON / 20 mL in 1 VIAL 2023-07-01 — Active
55566-1050-02 55566-1050-2 20 mL in 1 VIAL 2025-10-13 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 vial in 1 carton / 20 ml in 1 vial.
What NDC number is used to bill for this package of ADSTILADRIN nadofaragene firadenovec-vncg 300000000000 {VP}/mL Suspension?
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
Adstiladrin 300000000000 {VP}/mLthis 55566-1050-01 Ferring 4 vials — — 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

🏛️
2022
First FDA approval
Dec 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2034. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 16, 2022 ⏳ ~8.2 yr to latest listed protection

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
Adstiladrinnadofaragene firadenovec-vncg
🔒 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.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2022 2024 2026 2028 2030 2032 2034
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 dateDec 16, 2034
Common questions
Is there a biosimilar for ADSTILADRIN VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.95 mg / 1 mL UNII XTC7H88KND
    A complex detergent-like molecule derived from bile acids and sugar components. It acts as a solubilizer and emulsifier, helping dissolve or mix poorly water-soluble drug ingredients so they can be absorbed better in the body.
  • 0.01 mg / 1 mL UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 84 mg / 1 mL UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 7.9 mg / 1 mL UNII 1I96OHX6EK
    A cyclic carbohydrate derived from plant starch that acts as a solubilizer and stabilizer. It helps dissolve poorly water-soluble drugs and protects active ingredients from degradation in the formulation.
  • 0.34 mg / 1 mL UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • 0.48 mg / 1 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 1.4 mg / 1 mL UNII 5QWK665956
    A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
  • 17 mg / 1 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 0.04 mg / 1 mL UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 1.4 mg / 1 mL UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFerring Pharmaceuticals Inc.
FDA applicationBLA125700 (BLA)
Labeler code55566
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio17 products on file

More NDCs from Ferring Pharmaceuticals Inc. labeler code 55566

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 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 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 72 words ▾

1 INDICATIONS AND USAGE ADSTILADRIN ® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Important Administration Instructions ADSTILADRIN is for intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration. Premedication with an anticholinergic is recommended before each instillation of ADSTILADRIN.

( 2.1 ) Administer ADSTILADRIN by intravesical instillation only. ( 2.1 ) ADSTILADRIN is not for intravenous use, topical use, or oral administration. ( 2 ) The dose is 75 mL of ADSTILADRIN at a concentration of 3 x 10 11 viral particles (vp)/mL, instilled once every three (3) months.

( 2.1 ) Allow ADSTILADRIN to be left in the bladder for 1 hour following instillation. ( 2.3 )

2.1Dose The recommended dose of ADSTILADRIN is 75 mL at a concentration of 3 x 10 11 viral particles (vp)/mL instilled once every three (3) months into the bladder via a urinary catheter [ see Dosage and Administration (2.2) ]. Premedication with an anticholinergic is recommended before each instillation of ADSTILADRIN.

2.2Preparation and Handling ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Follow universal biosafety precautions for handling. Individuals who are immunosuppressed or immune-deficient, should not prepare, administer, or come into contact with ADSTILADRIN [ see Warnings and Precautions ( 5 ) ].

ADSTILADRIN is provided as a sterile frozen suspension. All four vials of ADSTILADRIN must be thawed and brought to room temperature (20°C to 25°C [68°F to 77°F]) prior to use. Do not expose the vials to higher temperatures (>25°C [77°F]).

Protect from light. DO NOT refreeze. ADSTILADRIN may be moved between refrigerator and room temperature if the total storage time at each condition is not exceeded (24 hours at room temperature and 7 days refrigerated including thawing time). [ see How Supplied/Storage and Handling (16) ] WHEN THAWING IN WATER BATH Frozen ADSTILADRIN vials will thaw in approximately 25 minutes outside the cardboard nest when placed directly in a water bath maintained at 25°C [77ºF].

Place the vials in the water bath, ensuring that the water level is sufficient to cover the product within the vials. Following thawing, remove vials from the water bath and dry with a clean paper towel to remove any residual moisture prior to further handling. WHEN THAWING AT ROOM TEMPERATURE Frozen ADSTILADRIN vials will thaw in approximately 3 to 5 hours outside the cardboard nest when placed at room temperature (up to 25°C [77ºF]) (8 to 10 hours inside the nest).

WHEN THAWING IN REFRIGERATOR Frozen ADSTILADRIN vials will thaw in approximately 4 to 5 hours outside the cardboard nest when placed in the refrigerator (up to 8°C [46ºF]) (11 to 13 hours inside the nest). Subsequent time for bringing thawed ADSTILADRIN to room temperature is approximately 2 hours 30 minutes outside of the cardboard nest (6 hours inside the nest). Inspection and Preparing ADSTILADRIN for instillation Visually inspect all 4 vials for visible particles and discoloration.

The suspension is clear to slightly opalescent and may contain opalescent flecks. Do not use if visible particles or discoloration are observed. Mix gently.

Do not shake. Items required for instillation: 70% isopropyl ethanol pads Four (4) thawed vials of ADSTILADRIN Four (4) vented vial adapters suitable for a standard 20 mL vial Two (2) standard 50 or 60 mL polypropylene Luer lock syringes or one (1) Luer lock syringe equal to or greater than 75 mL (max 100 mL) Two (2) Luer lock adapters One (1) straight, or intermittent, urethral catheter with a proximal funnel opening that will accommodate the Luer lock adapter. Use only catheters made of vinyl/PVC (uncoated or coated with hydrogel), red rubber latex or silicone to instill ADSTILADRIN.

Do not use catheters coated or embedded with silver or antibiotics. Using aseptic technique, remove the cap from an ADSTILADRIN vial. Prior to vial access, wipe the access diaphragm with 70% isopropyl alcohol pad, allowing it to air dry before proceeding.

Attach… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 113 words ▾

3 DOSAGE FORMS AND STRENGTHS ADSTILADRIN is a sterile, clear to opalescent suspension for intravesical instillation, supplied as single-use vials. ADSTILADRIN is provided in a carton containing four (4) vials. All vials have a nominal concentration of 3 × 10 11 viral particles (vp)/mL.

Each vial of ADSTILADRIN contains an extractable volume of not less than 20 mL. ADSTILADRIN is a suspension for intravesical instillation, supplied as single-use vials. ( 3 ) ADSTILADRIN is provided in a carton containing four (4) vials.

All vials have a nominal concentration of 3 × 10 11 viral particles (vp)/mL. Each vial of ADSTILADRIN contains an extractable volume of not less than 20 mL. ( 3 )

⛔ Contraindications 45 words ▾

4 CONTRAINDICATIONS ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product [ see Description (11) ]. ADSTILADRIN is contraindicated in patients with hypersensitivity to interferon alfa or any component of the product. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Delaying cystectomy could lead to the development of metastatic bladder cancer, which can be lethal. ( 5.1 ) Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals. ( 5.2 )

5.1Risk of Muscle Invasive or Metastatic Bladder Cancer with Delayed Cystectomy Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS. Of the patients with CIS treated with ADSTILADRIN on Study CS-003 who underwent subsequent radical cystectomy and for whom pathologic data were available, 14% (n = 6) had muscle-invasive (T2 or greater) disease at cystectomy.

Median time from persistence or recurrence of CIS to cystectomy in these patients was 235 days (range 38 to 582 days). Two additional patients who did not undergo cystectomy experienced progression to muscle-invasive disease during the treatment period. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.

5.2Risk of Disseminated Adenovirus Infection Immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection because of the possible presence of low levels of replication-competent adenovirus in ADSTILADRIN. Individuals who are immunosuppressed or immune-deficient should not come into contact with ADSTILADRIN.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals at 1-888-337-7464 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 safety of ADSTILADRIN was evaluated in Study CS-003, a multicenter, single-arm, open-label study in 157 U.S. patients [ see Clinical Studies (14 ) ] with high-risk BCG‑unresponsive NMIBC, 107 of whom had BCG-unresponsive carcinoma in situ (CIS) with or without papillary tumors.

Patients received 75 mL (3 x 10 11 vp/mL) ADSTILADRIN administered intravesically once every 3 months for up to 12 months [ see Clinical Studies (14 ) ]. All patients with an absence of high-risk recurrence or progression were offered continued treatment every 3 months beyond 12 months. The median number of instillations of ADSTILADRIN was 2 (range 1 to 5).

Serious adverse reactions occurred in 11% of patients who received ADSTILADRIN. Serious adverse reactions occurring in >1% of patients included coronary artery disease and hematuria (blood in urine). Permanent discontinuation of ADSTILADRIN due to an adverse reaction occurred in 3 (1.9%) patients.

Adverse reactions that resulted in permanent discontinuation of ADSTILADRIN included bladder spasm instillation site discharge, and benign neoplasm of the bladder. Dosage interruptions of ADSTILADRIN due to an adverse reaction occurred in 54 (34%) patients. Adverse reactions in >10% of patients that required dosage interruption included instillation site discharge, bladder spasm, and micturition urgency.

The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination) urgency, creatinine increased, hematuria (blood in urine), phosphate decreased, chills, dysuria, and pyrexia (fever). Tables 1 and 2 summarize adverse reactions and laboratory abnormalities, respectively, in patients on ADSTILADRIN in CS-003. Clinically relevant adverse reaction in <10% of patients who received ADSTILADRIN include syncope (fainting) (1.3%).

Table 1: Adverse Reactions (>10%) in Patients with NMIBC in CS-003 Adverse Reaction Graded per NCI CTCAE v4.03; there were no Grade 4 or 5 reactions. ADSTILADRIN Grade 1 and 2 (n=157) % ADSTILADRIN Grade 3 (n=157)% General disorders and administration site conditions - - Instillation site discharge 33 0 Fatigue 24 0 Pyrexia 16 0 Chills 15 0 Renal and urinary disorders - - Bladder spasm 20 1 Micturition urgency 19 1 Hematuria 17 1 Dysuria 16 0 Clinically relevant adverse reactions in <10% of patients who received ADSTILADRIN included coronary artery disease (1.3%), acute coronary syndrome (1.3%), atrial fibrillation (1.3%), dehydration (1.3%), hypoglycemia (low blood sugar) (1.3%), syncope (fainting) (1.3%), heart failure (0.6%), pericarditis, (0.6%), brain edema (swelling) (0.6%), bile duct stone (0.6%), and sepsis (0.6%).

Table 2 summarizes the laboratory abnormalities in CS-003. Table 2: Selected Laboratory Abnormalities (>15.0%) That Worsened from Baseline in Patients with NMIBC in CS-003 Laboratory Abnormality ADSTILADRIN The denominator used to calculate the rate varied from 148 to 156 based on the number of patients with a baseline value and at least one post-treatment value. (All Grades, %) ADSTILADRIN (Grade 3 or 4, %) Chemistry - - Glucose… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Immunocompromise/immunodeficiency: Avoid in patients with immunocompromise or immunodeficiency. ( 8 )

8.1Pregnancy Risk Summary Adequate and well-controlled studies with ADSTILADRIN have not been conducted in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with ADSTILADRIN. Advise pregnant women of the potential risk to a fetus. 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.

8.2Lactation Risk Summary There is no information regarding the presence of ADSTILADRIN in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ADSTILADRIN and any potential adverse effects on the breastfed infant from ADSTILADRIN or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential No nonclinical or clinical studies were performed to evaluate the effect of ADSTILADRIN on fertility. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating ADSTILADRIN. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with ADSTILADRIN and for 6 months following the last dose.

Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ADSTILADRIN and for 3 months following the last dose.

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

8.5Geriatric Use Clinical studies of ADSTILADRIN in BCG-unresponsive high-risk NMIBC with CIS did not include sufficient numbers of patients younger than 65 years of age to determine whether safety and effectiveness differ from older patients.

8.6Gender-specific Use In clinical studies with ADSTILADRIN, no overall differences in safety or efficacy were observed between females and males.

🤰 Pregnancy 67 words ▾

8.1Pregnancy Risk Summary Adequate and well-controlled studies with ADSTILADRIN have not been conducted in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with ADSTILADRIN. Advise pregnant women of the potential risk to a fetus. 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.

🧒 Pediatric Use 15 words ▾

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

🧓 Geriatric Use 36 words ▾

8.5Geriatric Use Clinical studies of ADSTILADRIN in BCG-unresponsive high-risk NMIBC with CIS did not include sufficient numbers of patients younger than 65 years of age to determine whether safety and effectiveness differ from older patients.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy designed to deliver a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to the bladder urothelium. Intravesical instillation of ADSTILADRIN results in cell transduction and transient local expression of the IFNα2b protein that is anticipated to have anti-tumor effects.

12.2Pharmacodynamics A Phase 1 first-in-human study was performed to determine the safety, tolerability, and maximum tolerated dose (MTD) of ADSTILADRIN in 17 patients with BCG-unresponsive NMIBC. Five dose levels (3 x 10 9 vp/mL, 1 x 10 10 vp/mL, 3 x 10 10 vp/mL, 1 x 10 11 vp/mL, and 3 x 10 11 vp/mL; all in a dose volume of 75 mL) of ADSTILADRIN were tested and quantifiable concentrations of the pharmacodynamic marker IFNα2b protein were detected in the urine of all patients, with the exception of two patients at the lowest dose level.

Measurable concentrations of urine IFNα2b protein up to Day 10 post-dose suggested expression of IFNα2b in the bladder. In a Phase 2 study, all patients had quantifiable concentrations of IFNα2b protein in the urine at Day 2 after dosing with ADSTILADRIN at two different dose levels (1 x 10 11 vp/mL and 3 x 10 11 vp/mL). Measurable concentrations of urine IFNα2b protein was detected up to Day 12 post-dose.

This was more common in patients at the high dose level. Generally, higher IFNα2b concentrations and exposure were observed with increasing doses of ADSTILADRIN.

12.3Pharmacokinetics Nonclinical data Human IFN protein in urine, and vector-specific DNA in blood and tissue samples, were detectable following ADSTILADRIN dosing in monkeys, with higher levels at higher doses. All monkeys had vector-specific DNA in the bladder tissue at necropsy on Days 8 and 98 (i.e., seven days after the first and second dose, respectively). Vector-specific DNA was also detected in a limited number of monkeys in the liver, kidney and gonad.

At Day 148, only one animal showed vector-specific DNA in one tissue (kidney). Clinical data ADSTILADRIN biodistribution and shedding were investigated in two clinical studies. Only a single patient receiving a second dose in one study (Phase 2 study) at dose level of 3 x 10 11 vp/mL (2.25 x 10 13 vp) had measurable vector DNA in blood; no other patients in either study had measurable vector DNA at one hour post-dosing in blood.

In urine, measurable vector DNA was detected in both studies. Generally, a higher frequency of detection of urine samples positive for vector-derived DNA, and persistence of vector-derived DNA, correlated with increasing dose level. At the dose level of 3 x 10 11 vp/mL (2.25 x 10 13 vp), one patient (out of 4 enrolled) had detectable levels of vector DNA at Day 14 in the Phase 1 study and 16 subjects (out of 19 at visit) had detectable levels of vector DNA at Day 12 in the Phase 2 study.

🧬 Mechanism of Action 53 words ▾

12.1Mechanism of Action ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy designed to deliver a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to the bladder urothelium. Intravesical instillation of ADSTILADRIN results in cell transduction and transient local expression of the IFNα2b protein that is anticipated to have anti-tumor effects.

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

16 HOW SUPPLIED/STORAGE AND HANDLING ADSTILADRIN is shipped frozen at ≤ -60°C (≤ -76°F) in an insulated shipping box that will maintain the required temperature for a minimum of 72 hours after being sealed. Each carton (NDC 55566-1050-1) contains a removable cardboard nest of four (4) clear glass vials of ADSTILADRIN. Each vial contains a sterile frozen suspension with an extractable volume of 20 mL and is either sealed with a bromobutyl rubber stopper and a tamper-evident aluminum crimp (NDC 55566-1050-0) or with a bromobutyl rubber stopper embedded within a press-fit closure (NDC 55566-1050-2).

Upon receipt, cartons of ADSTILADRIN can be stored as indicated below: In a freezer ≤ -60°C (≤ -76°F) until expiry date printed on the carton. In a freezer between -25°C to -15°C (-13°F to 5°F) up to 3 months, without exceeding the original expiry date printed on the vial and outer carton. When stored in freezer, the date of placement in freezer should be noted.

In addition, the date for when the carton should be discarded if not used, must be written on the outer carton. These dates should be three months apart but should not past the original expiry date. This discard date supersedes the original expiry date.

When thawed, ADSTILADRIN is a clear to opalescent suspension, with nominal concentration of 3 × 10 11 viral particles (vp)/mL. Prior to use, ADSTILADRIN must be brought to room temperature (20°C to 25°C [68°F to 77°F]). ADSTILADRIN may be stored for up to 24 hours at room temperature and a total of up to 7 days refrigerated at 2°C to 8°C (36°F to 46°F), including thawing time.

After withdrawing the suspension into syringes, the syringes may be stored for up to 6 hours at room temperature (20°C to 25°C [68°F to 77°F]). • Protect the vials from light. [ see Dosage and Administration (2.2 ) ]. • DO NOT REFREEZE • ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Follow universal biosafety precautions for handling [ see Dosage and Administration (2.2 ) ]. • Dispose of unused product and disposable materials that may have come in contact with ADSTILADRIN in accordance with local biosafety guidelines applicable for handling and disposal of the biohazard waste.

📋 Description 121 words ▾

11 DESCRIPTION ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation. It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b). ADSTILADRIN has a nominal concentration of 3 x 10 11 vp/mL.

A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s.

1 mL). ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative.

💬 Information for Patients 184 words ▾

17 PATIENT COUNSELING INFORMATION Risk of Metastatic Bladder Cancer with Delayed Cystectomy Inform patients that delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle-invasive or metastatic bladder cancer. Discuss the risk of muscle-invasive or metastatic bladder cancer and that the risk increases the longer cystectomy is delayed in the presence of persisting CIS [ see Warnings and Precautions (5.1) ] . Risk of Disseminated Adenovirus Infection Inform patients and their caregivers that treatment or contact with ADSTILADRIN in those who are immunocompromised, including those receiving immunosuppressive therapy, may increase the risk for disseminated adenovirus infection [ see Warnings and Precautions (5.2) ] .

Shedding of ADSTILADRIN Inform patients and their caregivers that transient and low‑level shedding of ADSTILADRIN may occur in urine. Instruct patients and their caregivers that for 2 days following treatment, voided urine should be disinfected for 15 minutes with an equal volume of bleach before flushing [ see Dosage and Administration (2.2) ] . Manufactured for: Ferring Pharmaceuticals 2770 Kastrup, Denmark U.S.

License No. 2222 ADSTILADRIN®, Ferring and the Ferring Pharmaceuticals logo are trademarks of Ferring. XXXXXXXXXX

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Nonclinical data Human IFN protein in urine, and vector-specific DNA in blood and tissue samples, were detectable following ADSTILADRIN dosing in monkeys, with higher levels at higher doses. All monkeys had vector-specific DNA in the bladder tissue at necropsy on Days 8 and 98 (i.e., seven days after the first and second dose, respectively). Vector-specific DNA was also detected in a limited number of monkeys in the liver, kidney and gonad.

At Day 148, only one animal showed vector-specific DNA in one tissue (kidney). Clinical data ADSTILADRIN biodistribution and shedding were investigated in two clinical studies. Only a single patient receiving a second dose in one study (Phase 2 study) at dose level of 3 x 10 11 vp/mL (2.25 x 10 13 vp) had measurable vector DNA in blood; no other patients in either study had measurable vector DNA at one hour post-dosing in blood.

In urine, measurable vector DNA was detected in both studies. Generally, a higher frequency of detection of urine samples positive for vector-derived DNA, and persistence of vector-derived DNA, correlated with increasing dose level. At the dose level of 3 x 10 11 vp/mL (2.25 x 10 13 vp), one patient (out of 4 enrolled) had detectable levels of vector DNA at Day 14 in the Phase 1 study and 16 subjects (out of 19 at visit) had detectable levels of vector DNA at Day 12 in the Phase 2 study.

🧬 Pharmacodynamics 190 words ▾

12.2Pharmacodynamics A Phase 1 first-in-human study was performed to determine the safety, tolerability, and maximum tolerated dose (MTD) of ADSTILADRIN in 17 patients with BCG-unresponsive NMIBC. Five dose levels (3 x 10 9 vp/mL, 1 x 10 10 vp/mL, 3 x 10 10 vp/mL, 1 x 10 11 vp/mL, and 3 x 10 11 vp/mL; all in a dose volume of 75 mL) of ADSTILADRIN were tested and quantifiable concentrations of the pharmacodynamic marker IFNα2b protein were detected in the urine of all patients, with the exception of two patients at the lowest dose level.

Measurable concentrations of urine IFNα2b protein up to Day 10 post-dose suggested expression of IFNα2b in the bladder. In a Phase 2 study, all patients had quantifiable concentrations of IFNα2b protein in the urine at Day 2 after dosing with ADSTILADRIN at two different dose levels (1 x 10 11 vp/mL and 3 x 10 11 vp/mL). Measurable concentrations of urine IFNα2b protein was detected up to Day 12 post-dose.

This was more common in patients at the high dose level. Generally, higher IFNα2b concentrations and exposure were observed with increasing doses of ADSTILADRIN.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of ADSTILADRIN was evaluated in CS-003 (NCT02773849), an open-label, multicenter, single-arm trial in 103 adults with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors following transurethral resection, of whom 98 were considered evaluable for response. BCG-unresponsive high-risk NMIBC was defined as persistent disease following adequate BCG therapy, disease recurrence after an initial tumor-free state following adequate BCG therapy, or T1 disease following a single induction course of BCG.

Adequate BCG was defined as the administration of at least five of six doses of an initial induction course plus either of: at least two of three doses of maintenance therapy or at least two of six doses of a second induction course. Prior to treatment, all patients had undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components). Residual CIS (Tis components) not amenable to complete resection was allowed.

The trial excluded patients with extra-vesical (i.e., urethra, ureter, or renal pelvis), muscle invasive (T2-T4), or metastatic urothelial carcinoma. Patients received ADSTILADRIN 75 mL intravesical instillation (3 x 10 11 vp/mL) once every three months for up to 12 months (four doses) or until unacceptable toxicity or recurrent high-grade (HG) NMIBC. Patients without evidence of HG recurrence were allowed to continue ADSTILADRIN treatment every three months.

The major efficacy outcome measures were complete response (CR) at any time (as defined by negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response. Low-grade (Ta) papillary disease was not considered a recurrence for the purposes of evaluating CR. CR was assessed at 3, 6, 9, and 12 months by cystoscopy and cytology.

Random bladder biopsy of five sites was conducted in patients remaining in CR at Month 12. Assessment of durability of CR subsequent to these evaluations was performed per local standards of care. The evaluable CIS study population characteristics were median age of 70 (range 44-89) with 32% >75 years of age; 88% male, 92% White.

Tumor pattern at study entry was CIS with T1 (5%), CIS with high-grade Ta (19%), and CIS (76%). The median number of instillations of prior BCG was 12 (range 8 to 18). Efficacy results are summarized in Table 3.

Table 3: Efficacy Results in Study CS-003 Efficacy Outcome Measure ADSTILADRIN (n=98) Complete Response Rate, % 51% (95% CI) (41%, 61%) Duration of Response Based on patients (n=50) that achieved a complete response; reflects period from the time complete response was achieved. - Median in months (range) 9.7 (3, 52+) % with duration ≥ 12 months 46%

🧪 Nonclinical Toxicology 145 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been conducted to evaluate the effects of ADSTILADRIN on carcinogenesis, mutagenesis, or impairment of fertility.

13.2Animal Toxicology and/or Pharmacology In cynomolgus monkeys, two repeat intravesical administrations of ADSTILADRIN of either 2.5 x 10 11 or 1.25 x 10 13 viral particles (1 x 10 10 or 5x10 11 viral particles/mL, 90 days apart) were associated with inflammation, urothelial hyperplasia, cytoplasmic vacuolation, and focal/multifocal ulceration in the urinary bladder and irritation in the ureter and urethra at necropsy 7 days after the first and second doses. Near complete resolution of these findings was observed following the 57-day recovery period after the second administration, with minimal fibrosis in the lamina propria of the bladder in a limited number of monkeys.

Both dose level groups developed antibodies to the adenovirus and human interferon protein.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 25 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been conducted to evaluate the effects of ADSTILADRIN on carcinogenesis, mutagenesis, or impairment of fertility.

📄 Patient Package Insert ~2 min read ▾

PATIENT INFORMATION ADSTILADRIN ® (add-STILL-a-drin) (nadofaragene firadenovec-vncg) Suspension for Intravesical Use Read this Patient Information before you have each ADSTILADRIN treatment. This information is not comprehensive and there may be new information. How to get more information: Talk to your health care provider Call 1-888-337-7464 What is the most important information I should know about ADSTILADRIN?

Individuals who are immunosuppressed or immune-deficient should not prepare, administer, receive or come into contact with ADSTILADRIN. What is ADSTILADRIN used for? ADSTILADRIN is a prescription medicine for the treatment of a certain type of bladder cancer.

What is ADSTILADRIN? ADSTILADRIN is a therapy that contains a copy of the gene for human interferon alfa-2b. When administered into the bladder, the treatment delivers this gene, which is non-replicating, to cells in your bladder wall.

Interferon alfa-2b has anti-tumor effects. The purpose of this gene therapy is to increase the level and length of time your bladder wall is exposed to interferon alfa-2b protein. You should not receive ADSTILADRIN if: You have a sensitivity to interferon alfa or any of its components.

What should I tell my healthcare provider? Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of ADSTILADRIN?

The most common side effects of ADSTILADRIN include: Urinary discharge Fatigue Bladder spasm Urgency to urinate Blood in your urine These common side effects (above) are not all the possible side effects of ADSTILADRIN. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Ferring Pharmaceuticals at 1-888-337-7464. How is ADSTILADRIN used?

Once every 3 months your healthcare provider will administer 75 mL (about 2 and a half ounces) of ADSTILADRIN into your bladder through a urinary catheter and leave it there for 1 hour. During this time your healthcare provider may move you about every 15 minutes. What other information should I know about using ADSTILADRIN?

Take these steps to prepare your toilet bowl after each treatment: Add about half a cup of bleach to the toilet bowl before you urinate. After urinating, wait 15 minutes before flushing the toilet. Repeat these steps every time you urinate for the first 2 days after treatment.

For more information, call 1-888-337-7464 or talk with your health care provider. This Patient Information has been approved by the U.S. Food and Drug Administration.

Issued: 03/2026 Rx Only Manufactured for: Ferring Pharmaceuticals 2770 Kastrup, Denmark ADSTILADRIN®, Ferring and the Ferring Pharmaceuticals logo are trademarks of Ferring.

📄 Recent Major Changes 7 words ▾

Dosage and Administration ( 2.2 ) 03/2026

📄 Package Label / Principal Display Panel 73 words ▾

PRINCIPAL DISPLAY PANEL - Outer Carton NDC 55566-1050-1 Rx Only nadofaragene firadenovec-vncg ADSTILADRIN 75 mL Intravesical Suspension Each carton contains 4 x 20 mL vials Each vial contains 3 x 10 11 viral particles/mL No U.S. standard of potency For Intravesical Instillation Only Sterile suspension Preservative free Discard unused portion U.S. Licence No. 2222 Manufactured for Ferring Pharmaceuticals A/S, 2770 Kastrup, Denmark by FinVector Oy, Kuopio, Finland Principal Display Panel - Outer Carton

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

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

Medicare Part D (outpatient prescription) spending for Adstiladrin — 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 Adstiladrin. 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
$3.17M
Claims incl. refills
51
Beneficiaries
51
Spend / beneficiary
$62,143.94
Spend / claim
$62,143.94
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
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Ferring Pharmaceuticals 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 1 other package presentation of this same product, including 20 ml (55566-1050-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Ferring Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9029 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 55566-1010-01 · Ferring 55566-1502-01 · Ferring →
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.