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ZELSUVMI berdazimer Kit — NDC 83787-0103-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ZELSUVMI berdazimer Kit — NDC 83787-103-31 (Billing 83787-0103-31)

by LNHC, Inc. · 1 KIT in 1 KIT * 1 TUBE in 1 CARTON / 17 g in 1 TUBE * 1 TUBE in 1 CARTON / 14 g in 1 TUBE

This is a package of ZELSUVMI berdazimer Kit from LNHC, Inc., marketed since Apr 2025 and currently FDA-listed; retail pharmacies pay about $61.89 per g (NADAC). It is this product's only package size.

NDC 83787-0103-31
🏷️ FDA NDC (as labeled) 83787-103-31 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 83787-103-31 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
83787 labeler · 103 product · 31 package
Package marketed since
Apr 4, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8378710331 8
Medicaid fills, this package
4,281 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83787-103-31
Product NDC 83787-103
11-digit billing NDC 83787010331
NCPDP billing unit GM — per gram (weight)
RxCUI 2710438, 2710443
Application # NDA217424
SPL Set ID 76b17622-bdb9-41ea-b962-c2acc0df71f7
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-04
Dosage form KIT

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

GPI-14 90350014504020
GCN Seq No 085650
GCN 55169
HICL code 049364
Ingredient (HICL) Berdazimer Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q52
Therapeutic class — specific (HIC3) Topical Nitric Oxide Releasing Agents
AHFS code 84:04.06.00
AHFS class Antivirals (Skin And Mucous Membrane)
FDB label name ZELSUVMI 10.3% GEL
FDB brand name Zelsuvmi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085650
  • GCN: 55169
  • GPI-14 (Medi-Span): 90350014504020
  • HICL (First Databank): 049364
  • AHFS class code: 84:04.06.00
  • RxCUI (RxNorm): 2710438
Why two NDCs? The FDA registers this code as 83787-103-31 — 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 → 83787-0103-31. 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 Nitric Oxide Releasing Agent class.

Pharmacologic class Nitric Oxide Releasing Agent
Drug family (ATC) Antivirals
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 ZELSUVMI 10.3% GEL Ingredient Berdazimer Sodium
📖 What it is MedlinePlus · NLM

Berdazimer topical is used to treat molluscum contagiosum (MC; infection caused by a virus that causes little bumps to form on skin anywhere on the body) in adults and children over the age of 1 year. Berdazimer is in a class of medications called nitric oxide releasing agents. How it works to treat MC is not fully understood.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Berdazimer — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Berdazimer (3 interactions) — ranked by severity →
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 gPer package
Retail pharmacies payNADAC · weekly $61.891 —
Medicaid paysCMS SDUD · 12 mo $808.44 —
Medicare drug plans payPart D · Q2 2026 $64.32 —
NADAC price history (per g) — tap or hover for the price & month
Jan 2026 May 2026 Jul 2026 Sep 2026 $61.891 $61.563
▲ Up 1% over the last 6 months.
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
83787-0103-31 You're viewing this Main listing 1 KIT in 1 KIT * 1 TUBE in 1 CARTON / 17 g in 1 TUBE * 1 TUBE in 1 CARTON / 14 g in 1 TUBE 2025-04-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zelsuvmithis 83787-0103-31 LNHC, 1 kit $61.891 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
First FDA approval
Jan 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 5, 2024 RLD RS ⏳ ~8.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11723858 — method of use (U-3788)
US 11040006 — method of use (U-3789)
US 10736839 — method of use (U-3790)
US 10736839 — method of use (U-3791)
US 10736839 — method of use (U-3792)
US 10322081 — method of use (U-3793)
US 10322081 — method of use (U-3794)
US 10322081 — method of use (U-3795)
US 10322081 — method of use (U-3796)
US 10258564 — method of use (U-3797)
US 10258564 — method of use (U-3798)
US 10258564 — method of use (U-3799)
US 9855211 — method of use (U-3800)
US 9855211 — method of use (U-3801)
US 9737561 — method of use (U-3802)
US 9289442 — method of use (U-3803)
US 11285098 — drug product
US 8956658 — drug substance
US 10376538 — drug product
US 9526738 — drug product
US 8282967 — drug substance
US 10265334 — drug product
Exclusivity NCE
2024 2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (22)
PatentTypeUse codeExpires
US 11723858 ↗ Method of use U-3788 Jul 10, 2035
US 11040006 ↗ Method of use U-3789 Jul 10, 2035
US 10736839 ↗ Method of use U-3790 Jul 10, 2035
US 10736839 ↗ Method of use U-3791 Jul 10, 2035
US 10736839 ↗ Method of use U-3792 Jul 10, 2035
US 10322081 ↗ Method of use U-3793 Jul 10, 2035
US 10322081 ↗ Method of use U-3794 Jul 10, 2035
US 10322081 ↗ Method of use U-3795 Jul 10, 2035
US 10322081 ↗ Method of use U-3796 Jul 10, 2035
US 10258564 ↗ Method of use U-3797 Nov 22, 2034
US 10258564 ↗ Method of use U-3798 Nov 22, 2034
US 10258564 ↗ Method of use U-3799 Nov 22, 2034
US 9855211 ↗ Method of use U-3800 Feb 27, 2034
US 9855211 ↗ Method of use U-3801 Feb 27, 2034
US 9737561 ↗ Method of use U-3802 Aug 20, 2030
US 9289442 ↗ Method of use U-3803 Jul 3, 2032
US 11285098 ↗ Drug product — Feb 28, 2034
US 8956658 ↗ Drug substance — May 30, 2026
US 10376538 ↗ Drug product — Aug 20, 2030
US 9526738 ↗ Drug product — Sep 3, 2031
US 8282967 ↗ Drug substance — May 30, 2026
US 10265334 ↗ Drug product — Jul 3, 2032
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Jan 5, 2029
Common questions
Is there a generic version of ZELSUVMI 10.3% GEL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ZELSUVMI 10.3% GEL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerLNHC, Inc.
Application holderLNHC INC
FDA applicationNDA217424 (NDA)
Labeler code83787
First marketedApr 2025
Product typeHuman Prescription Drug
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 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

1 INDICATIONS AND USAGE ZELSUVMI™ is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ZELSUVMI™ is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Dispense equal amounts from Tube A and Tube B per the dosing guide. ( 2.2 ) Mix together and immediately apply a thin layer of ZELSUVMI. ( 2.2 ) Apply once daily to each MC lesion for up to 12 weeks. ( 2.2 ) For topical use only and not for ophthalmic, oral, or intravaginal use. ( 2.2 )

2.1Important Preparation and Administration Instructions ZELSUVMI is supplied in a carton containing the following: Tube A containing berdazimer gel Tube B containing hydrogel Dosing guide Mix together equal amounts of gel from Tube A and Tube B before application [see Dosage and Administration (2.2) ] . Do not premix or store mixed ZELSUVMI. Instruct the patient to refer to the ZELSUVMI “Instructions for Use” for detailed instructions on the preparation and administration of ZELSUVMI [see Instructions for Use] .

2.2Recommended Dosage and Administration Dispense equal amounts (0.5 mL) of gel from Tube A and Tube B on the dosing guide. Immediately put the caps back on Tube A and Tube B tightly. Mix together on the dosing guide.

Immediately apply ZELSUVMI as an even thin layer. Apply ZELSUVMI once daily to each MC lesion for up to 12 weeks. Wash hands after applying ZELSUVMI, unless hands are being treated.

Allow ZELSUVMI to dry for 10 minutes after application. Avoid application to uninvolved skin and avoid transfer of applied ZELSUVMI to other areas, including the eye. Avoid swimming, bathing, or washing for 1 hour after application of ZELSUVMI.

ZELSUVMI is for topical use only and not for ophthalmic, oral, or intravaginal use.

💊 Dosage Forms and Strengths 67 words ▾

3 DOSAGE FORMS AND STRENGTHS Topical gel: 10.3% berdazimer in an opaque white to off-white gel. ZELSUVMI is supplied as two tubes. Tube A with a blue label contains 14 grams of berdazimer gel and Tube B with a yellow label contains 17 grams of hydrogel. Topical gel: 10.3% berdazimer supplied as two tubes. Tube A contains berdazimer gel and Tube B contains hydrogel. ( 3 )

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions 75 words ▾

5 WARNINGS AND PRECAUTIONS Application Site Reactions: Application site reactions, including allergic contact dermatitis, occurred. Discontinue ZELSUVMI and initiate appropriate therapy. ( 5.1 )

5.1Application Site Reactions Application site reactions, including allergic contact dermatitis, have occurred in patients treated with ZELSUVMI. Suspect allergic contact dermatitis in the event of pain, pruritus, swelling or erythema at the application site lasting longer than 24 hours. If allergic contact dermatitis occurs, discontinue ZELSUVMI and initiate appropriate therapy.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) are application site reactions, including pain (such as burning or stinging sensations, 18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LNHC, Inc. at 1-855-330-7546 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. In three double-blind, vehicle-controlled clinical trials (Trial 1, and Trial 2 and Trial 3, which were similarly designed to Trial 1), 1596 adult and pediatric subjects were treated with ZELSUVMI or vehicle gel topically once daily for up to 12 weeks [see Clinical Studies (14) ].

In these trials 3% of subjects were less than 2 years of age, and 96% of subjects were 2 to 17 years of age. The trial population included 51% male, 88% White, 6% Black, and 6% Other; for ethnicity, 21% of subjects identified as Hispanic/Latino, 78% as non-Hispanic/Latino, and 1% were not reported. Adverse reactions reported by ≥1% of subjects and more frequently than vehicle-treated subjects are listed in Table 1.

Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with MC Treated with ZELSUVMI (and Greater than Vehicle) Day 1 through Week 12 in Trials 1, 2, and 3 ZELSUVMI N=916 Vehicle Gel N=680 Adverse Reaction Mild n (%) Moderate n (%) Severe n (%) Mild n (%) Moderate n (%) Severe n (%) Subjects with any TEAE* 220 (24.0) 192 (21.0) 16 (1.7) 118 (17.4) 47 (6.9) 4 (0.6) Application Site Pain† 113 (12.3) 56 (6.1) 2 (0.2) 30 (4.4) 3 (0.4) 0 Application Site Erythema 48 (5.2) 55 (6.0) 4 (0.4) 7 (1.0) 2 (0.3) 0 Application Site Pruritus 36 (3.9) 15 (1.6) 1 (0.1) 5 (0.7) 2 (0.3) 0 Application Site Exfoliation 18 (2.0) 26 (2.8) 2 (0.2) 0 0 0 Application Site Dermatitis 16 (1.7) 26 (2.8) 3 (0.3) 3 (0.4) 2 (0.3) 0 Application Site Swelling 17 (1.9) 14 (1.5) 1 (0.1) 3 (0.4) 1 (0.1) 0 Pyrexia 14 (1.5) 6 (0.7) 0 6 (0.9) 1 (0.1) 0 Application Site Erosion 7 (0.8) 5 (0.5) 3 (0.3) 1 (0.1) 0 0 Application Site Discoloration 13 (1.4) 1 (0.1) 0 1 (0.1) 0 0 Application Site Vesicles 5 (0.5) 9 (1.0) 0 0 1 (0.1) 0 Vomiting 5 (0.5) 7 (0.8) 0 1 (0.1) 0 0 Application Site Irritation 7 (0.8) 4 (0.4) 0 0 0 0 Upper Respiratory Tract Infection 6 (0.7) 5 (0.5) 0 4 (0.7) 1 (0.1) 0 Application Site Infection 4 (0.4) 4 (0.4) 2 (0.2) 2 (0.3) 1 (0.1) 0 * TEAE – treatment emergent adverse events † Application site pain also includes application site burning and stinging.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on ZELSUVMI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of berdazimer to pregnant rats and rabbits increased malformations in the presence of severe maternal toxicity ( see Data ). The clinical relevance of this finding is unknown given the bioavailability of berdazimer following oral administration is significantly higher than topical application.

The available data do not allow the calculation of relevant comparisons between the systemic exposure of berdazimer observed in animal studies and the systemic exposure that would be expected in humans after topical use of ZELSUVMI. The background risk of major birth defects and miscarriage for the indicated population 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. Data Animal Data Systemic embryo-fetal development studies were conducted in rats and rabbits. In an embryo-fetal development study in rats, oral dose levels of 28, 95, or 189 mg/kg/day berdazimer were administered during the period of organogenesis.

Maternal mortality and elevated methemoglobin levels were noted in dams receiving doses of 95 and 189 mg/kg/day. The maternal no observable adverse effect level (NOAEL) was 28 mg/kg/day. Fetal skeletal malformations (changes in the lumbar and thoracic centra or arches, missing thoracic arches and centra, additional bone in the thoracic arches, missing lumbar centra and arches, and fused ribs) and visceral malformations (cleft palate) and decreased fetal weights were observed in litters from dams receiving 189 mg/kg/day.

The fetal NOAEL was 95 mg/kg/day. In an embryo-fetal development study in rabbits, oral dose levels of 47, 142, or 284 mg/kg/day berdazimer were administered during the period of organogenesis. Maternal mortality, aborted fetuses, adverse clinical observations, and elevated methemoglobin levels were noted in pregnant rabbits receiving doses of 142 and 284 mg/kg/day.

The maternal NOAEL was 47 mg/kg/day. Decreased fetal weights were noted from pregnant rabbits receiving 284 mg/kg/day. The fetal NOAEL was 142 mg/kg/day.

8.2Lactation Risk Summary There are no data on the presence of berdazimer or its metabolite in either human or animal 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 ZELSUVMI and any potential adverse effects on the breastfed infant from ZELSUVMI or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ZELSUVMI for the topical treatment of MC have been established in pediatric patients 1 year of age and older. Use of ZELSUVMI for this indication is supported by data from three randomized, vehicle-controlled, double-blind trials involving 1596 subjects of which 1575 were pediatric subjects with MC (904 were exposed to ZELSUVMI; 29 subjects were less than 2 years of age, including one subject less than 1 year of age, and 875 were 2 to 17 years of age) [see Clinical Studies (14) ].

The safety and effectiveness of ZELSUVMI have not been established in pediatric patients younger than 1 year of age.

8.5Geriatric Use Of the total number of ZELSUVMI-treated subjects in clinical studies for MC, none were 65 to 74 years of age, and one was 75 years of age and older [see Clinical Studies (14) ] . Clinical studies of ZELSUVMI did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on ZELSUVMI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of berdazimer to pregnant rats and rabbits increased malformations in the presence of severe maternal toxicity ( see Data ). The clinical relevance of this finding is unknown given the bioavailability of berdazimer following oral administration is significantly higher than topical application.

The available data do not allow the calculation of relevant comparisons between the systemic exposure of berdazimer observed in animal studies and the systemic exposure that would be expected in humans after topical use of ZELSUVMI. The background risk of major birth defects and miscarriage for the indicated population 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. Data Animal Data Systemic embryo-fetal development studies were conducted in rats and rabbits. In an embryo-fetal development study in rats, oral dose levels of 28, 95, or 189 mg/kg/day berdazimer were administered during the period of organogenesis.

Maternal mortality and elevated methemoglobin levels were noted in dams receiving doses of 95 and 189 mg/kg/day. The maternal no observable adverse effect level (NOAEL) was 28 mg/kg/day. Fetal skeletal malformations (changes in the lumbar and thoracic centra or arches, missing thoracic arches and centra, additional bone in the thoracic arches, missing lumbar centra and arches, and fused ribs) and visceral malformations (cleft palate) and decreased fetal weights were observed in litters from dams receiving 189 mg/kg/day.

The fetal NOAEL was 95 mg/kg/day. In an embryo-fetal development study in rabbits, oral dose levels of 47, 142, or 284 mg/kg/day berdazimer were administered during the period of organogenesis. Maternal mortality, aborted fetuses, adverse clinical observations, and elevated methemoglobin levels were noted in pregnant rabbits receiving doses of 142 and 284 mg/kg/day.

The maternal NOAEL was 47 mg/kg/day. Decreased fetal weights were noted from pregnant rabbits receiving 284 mg/kg/day. The fetal NOAEL was 142 mg/kg/day.

🧒 Pediatric Use 110 words ▾

8.4Pediatric Use The safety and effectiveness of ZELSUVMI for the topical treatment of MC have been established in pediatric patients 1 year of age and older. Use of ZELSUVMI for this indication is supported by data from three randomized, vehicle-controlled, double-blind trials involving 1596 subjects of which 1575 were pediatric subjects with MC (904 were exposed to ZELSUVMI; 29 subjects were less than 2 years of age, including one subject less than 1 year of age, and 875 were 2 to 17 years of age) [see Clinical Studies (14) ].

The safety and effectiveness of ZELSUVMI have not been established in pediatric patients younger than 1 year of age.

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use Of the total number of ZELSUVMI-treated subjects in clinical studies for MC, none were 65 to 74 years of age, and one was 75 years of age and older [see Clinical Studies (14) ] . Clinical studies of ZELSUVMI did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

🧬 Clinical Pharmacology 145 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ZELSUVMI is a nitric oxide releasing agent. The mechanism of action for the treatment of molluscum contagiosum is unknown.

12.2Pharmacodynamics The pharmacodynamics of ZELSUVMI are unknown.

12.3Pharmacokinetics Plasma hydrolyzed MAP3 (hMAP3), a structural marker for berdazimer, and nitrate levels were evaluated in n=34 subjects 2 to 12 years of age with MC. Subjects applied ZELSUVMI once-daily for two weeks to a total treatment area of 484 cm 2 (mean lesion count=34), applying a mean dose of approximately 3 mL/day. No subjects had quantifiable plasma hMAP3 concentrations on day 1; two subjects had quantifiable concentrations on day 15.

Mean plasma nitrate levels were similar on days 1 and 15 and remained relatively flat during the PK sampling period (baseline through 1, 3, and 6 hours post-application). There were no apparent differences in methemoglobin levels throughout the study.

🧬 Mechanism of Action 23 words ▾

12.1Mechanism of Action ZELSUVMI is a nitric oxide releasing agent. The mechanism of action for the treatment of molluscum contagiosum is unknown.

📦 How Supplied / Storage and Handling 134 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZELSUVMI (berdazimer) topical gel, 10.3% is supplied in a carton (NDC 83787-103-31) containing: Tube A (14 g) with blue label containing berdazimer sodium in an opaque white to off-white gel (NDC 83787-113-14) Tube B (17 g) with yellow label containing translucent to opaque white to off-white gel (UPC 83787-0000-17) Dosing Guide Storage and Handling Prior to Dispensing : Store ZELSUVMI in a refrigerator between 2°C and 8°C (36°F and 46°F) until dispensed to the patient.

Write the “Discard after” date in the space provided on the carton. After Dispensing : Store ZELSUVMI at room temperature, between 20°C to 25°C (68°F and 77°F) in a dry location. Product contains alcohol and should be kept away from open flame.

Do not freeze. Discard 60 days after removal from refrigeration.

📋 Description 185 words ▾

11 DESCRIPTION ZELSUVMI (berdazimer) topical gel, 10.3%, a nitric oxide releasing agent, contains the drug substance berdazimer sodium, a white to off white powder with the chemical name poly[{[3-(methylamino)propyl]silasesquioxane}-co-{[3-(1-methyl-2-nitroso2-oxidohydrazin-1 yl)propyl]silasesquioxane}-co-silicate (1:3:6 x)], partially hydrolyzed (Si : OH ~ 10 : 5), and the following structural and empirical formula: Structural Formula: * Denotes shared oxygen atom between bonded constituents; resulting bonds are Si-O-Si or Si‑OH Empirical formula: [(C4H9N3NaO3.5Si)3(C4H10NO1.5Si)1(SiO2)6(HO0.5)5] 0.1n Due to the insoluble nature of berdazimer sodium, the molecular formula, molecular mass, and average molecular weight range cannot be determined.

ZELSUVMI (berdazimer) topical gel is an opaque white to off-white gel containing 10.3% berdazimer (equivalent to 10.9% berdazimer sodium). ZELSUVMI is supplied as two gel components that are mixed before administration: Tube A (14 g): an opaque white to off-white gel containing 240 mg of berdazimer sodium per gram of gel and the inactive ingredients cyclomethicone, hexylene glycol, hydroxypropyl cellulose, and isopropyl alcohol. Tube B (17 g): a translucent to opaque white to off-white gel containing the inactive ingredients benzoic acid, carboxymethylcellulose sodium, cyclomethicone, ethanol (13% v/v), glycerin, potassium phosphate monobasic, and purified water.

Structural Formula

💬 Information for Patients 182 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Application Site Reactions Advise patients to discontinue ZELSUVMI and seek medical attention immediately if signs or symptoms of application site reactions lasting more than 24 hours occur [see Warnings and Precautions (5.1) ]. Administration Instructions Advise patients that ZELSUVMI is for external use only and is not for ophthalmic, oral, or intravaginal use [see Dosage and Administration (2.2) ] .

Inform patients that ZELSUVMI is supplied with two gel components that must be mixed together immediately before application. Instruct patients not to premix or store mixed ZELSUVMI [see Dosage and Administration ( 2.1 , 2.2 )] . Advise patients to wash hands after applying ZELSUVMI (unless hands are being treated) and avoid transfer of the product to other areas of the skin, including the eye [see Dosage and Administration (2.2) ].

Instruct patients to carefully follow the instructions for preparing and administering ZELSUVMI in the ZELSUVMI FDA-approved patient labeling [see Instructions For Use ]. Manufactured for: LNHC, Inc. Durham, NC 27703

🧬 Pharmacokinetics 111 words ▾

12.3Pharmacokinetics Plasma hydrolyzed MAP3 (hMAP3), a structural marker for berdazimer, and nitrate levels were evaluated in n=34 subjects 2 to 12 years of age with MC. Subjects applied ZELSUVMI once-daily for two weeks to a total treatment area of 484 cm 2 (mean lesion count=34), applying a mean dose of approximately 3 mL/day. No subjects had quantifiable plasma hMAP3 concentrations on day 1; two subjects had quantifiable concentrations on day 15.

Mean plasma nitrate levels were similar on days 1 and 15 and remained relatively flat during the PK sampling period (baseline through 1, 3, and 6 hours post-application). There were no apparent differences in methemoglobin levels throughout the study.

🧬 Pharmacodynamics 8 words ▾

12.2Pharmacodynamics The pharmacodynamics of ZELSUVMI are unknown.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The efficacy of ZELSUVMI was evaluated in 3 multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials in subjects with MC (Trials 1, 2, and 3; NCT04535531 , NCT03927703 , and NCT03927716 , respectively). Trial 1 enrolled 891 subjects, Trial 2 enrolled 355 subjects, and Trial 3 enrolled 352 subjects. Subjects were randomized 1:1 in Trial 1, and 2:1 in Trials 2 and 3 to receive ZELSUVMI or vehicle applied to MC lesions once daily for up to 12 weeks.

In the three trials, 3% of subjects were less than 2 years of age and 96% of subjects were 2 to 17 years of age. The trial population included 51% male, 88% White, 6% Black, and 6% Other; for ethnicity, 21% of subjects identified as Hispanic/Latino, 78% as non-Hispanic/Latino, and 1% were not reported. Subjects had 3-70 baseline MC lesions.

At baseline, the average MC lesion count was 20.2. The primary efficacy endpoint was the proportion of subjects achieving complete clearance at Week 12. Complete clearance was defined as the subject having a total MC lesion count of 0 at assessment.

The key secondary efficacy endpoint was complete clearance rate at Week 8. Efficacy was demonstrated in Trials 1 and 2. The results are summarized in Table 2.

Table 2: Complete Clearance Rate at Week 12 and Week 8 in Subjects with MC in Trials 1 and 2 Trial 1 Trial 2 ZELSUVMI (N=444) Vehicle (N=447) ZELSUVMI (N=237) Vehicle (N=118) Complete Clearance Rate at Week 12 (Primary Endpoint) 32.4% 19.7% 30.0% 20.3% Treatment Difference (95% Confidence Interval) 12.8% (7.1%, 18.6%) 9.2% (-0.04%, 18.4%) Complete Clearance Rate at Week 8 (Secondary Endpoint) 19.6% 11.6% 13.9% 5.9% Treatment Difference (95% Confidence Interval) 7.5% (3.0%, 12.0%) 7.8% (1.8%, 13.8%) In Trial 3, the complete clearance rates at Week 12 were 26% versus 22% for ZELSUVMI and vehicle, respectively, with 95% confidence interval (-5%, 14%).

🧪 Nonclinical Toxicology 106 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of berdazimer gel was assessed in a 2-year dermal mouse carcinogenicity study. There were no drug-related tumor findings associated with daily topical administration of berdazimer gel to mice at doses up to 4% berdazimer gel. Berdazimer was mutagenic in a bacterial mutagenicity assay (Ames assay) but was not clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes or in an in vivo micronucleus assay in rats.

There were no berdazimer related effects on male or female fertility and early embryonic parameters in rats at oral doses up to 189 mg/kg/day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 103 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of berdazimer gel was assessed in a 2-year dermal mouse carcinogenicity study. There were no drug-related tumor findings associated with daily topical administration of berdazimer gel to mice at doses up to 4% berdazimer gel. Berdazimer was mutagenic in a bacterial mutagenicity assay (Ames assay) but was not clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes or in an in vivo micronucleus assay in rats.

There were no berdazimer related effects on male or female fertility and early embryonic parameters in rats at oral doses up to 189 mg/kg/day.

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert PATIENT INFORMATION ZELSUVMI™ (zel-SOOV-mee) (berdazimer) topical gel Important information: ZELSUVMI is for use on the skin (for topical use) only. Do not use ZELSUVMI near or in your eyes, mouth, or vagina. What is ZELSUVMI?

ZELSUVMI is a prescription medicine used on the skin (topical) to treat molluscum contagiosum (MC) in adults and children 1 year of age and older. It is not known if ZELSUVMI is safe and effective in children under 1 year of age. Before using ZELSUVMI, tell your healthcare provider about all your medical conditions, including if you: have other skin problems. are pregnant or plan to become pregnant.

It is not known if ZELSUVMI will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ZELSUVMI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ZELSUVMI.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ZELSUVMI? Read the Instructions for Use for detailed information about how to properly prepare and apply ZELSUVMI.

Use ZELSUVMI exactly as your healthcare provider tells you to use it. The ZELSUVMI carton contains: 1 tube that contains berdazimer gel (Tube A) 1 tube that contains hydrogel (Tube B) 1 Dosing Guide The gels contained in Tube A and Tube B must be mixed together on the Dosing Guide before you apply ZELSUVMI to your skin. Do not mix the gels until you are ready to apply ZELSUVMI.

After mixing, apply an even, thin layer of ZELSUVMI right away to each MC bump. Apply ZELSUVMI 1 time each day. Do not apply ZELSUVMI near or in your eyes, mouth, vagina, or areas of your skin where you do not have MC.

Allow ZELSUVMI to dry for 10 minutes and do not swim, take a bath or shower, or wash the areas where you applied ZELSUVMI for 1 hour after you apply it. Wash your hands after applying ZELSUVMI, unless your hands are being treated for MC. If someone else applies ZELSUVMI for you, they should wash their hands after applying ZELSUVMI.

What are the possible side effects of ZELSUVMI? ZELSUVMI may cause serious side effects, including: Application site reactions. Application site reactions, including allergic skin reactions, are common where ZELSUVMI is applied to your skin, but can also be severe.

Stop using ZELSUVMI and tell your healthcare provider right away if you develop pain, burning, stinging, itching, swelling, or redness of your skin that lasts for more than 24 hours after treatment with ZELSUVMI. The most common side effects of ZELSUVMI include: the following skin side effects at the application site: pain burning stinging redness itching peeling or flaking itchy, dry skin rash swelling breakdown of the outer layer of the skin (erosion) lightening or darkening of the skin blisters irritation infection These are not all of the possible side effects of ZELSUVMI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store ZELSUVMI?

Store ZELSUVMI at room temperature between 68°F to 77°F (20°C to 25°C) in a dry location. Do not premix or store mixed ZELSUVMI. Product contains alcohol and should be kept away from open flame.

Do not freeze ZELSUVMI. After use, immediately put caps back on Tube A (berdazimer gel) and Tube B (hydrogel) tightly. Throw away if not used within 60 days after receiving ZELSUVMI.

Keep ZELSUVMI and all medicines out of the reach of children. General information about the safe and effective use of ZELSUVMI. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use ZELSUVMI for a condition for which it was not prescribed. Do not give ZELSUVMI to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about ZELSUVMI that is wri… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use 9 words ▾

Instructions For Use IFU Page 1 IFU Step 1

📄 Package Label / Principal Display Panel 19 words ▾

PRINCIPAL DISPLAY PANEL - ZELSUVMI™ Carton Carton Tube A Carton Tube A Tube Tube B Carton Tube B Tube

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q1 2026 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.3K
Units reimbursed last 4 qtrs
10.3K
Gross reimbursed last 4 qtrs
$8.31M
Avg / prescription
$1,941.87
Avg / unit
$808.41
Latest quarter Q1 2026
1.9KRx
Medicaid pays / g
$808.41
gross reimbursed
vs
NADAC / g
$61.8908
acquisition cost
=
Spread
+$746.52
+1206% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
48% FFS 52% MCO
Fee-for-service · 2,068 Rx Managed care · 2,213 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 172 units · 2.2 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 30 units · 0.3 per 100k residents MI New York: 1,112 units · 5.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 21 units · 0.7 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 868 units · 6.9 per 100k residents IL Indiana: 31 units · 0.5 per 100k residents IN Ohio: 128 units · 1.1 per 100k residents OH Pennsylvania: 25 units · 0.2 per 100k residents PA New Jersey: 341 units · 3.7 per 100k residents NJ Massachusetts: 341 units · 4.9 per 100k residents MA California: 834 units · 2.1 per 100k residents CA Utah: no data reported UT Colorado: 12 units · 0.2 per 100k residents CO Nebraska: 13 units · 0.7 per 100k residents NE Missouri: no data reported MO Kentucky: 668 units · 14.8 per 100k residents KY West Virginia: no data reported WV Virginia: 11 units · 0.1 per 100k residents VA Maryland: 14 units · 0.2 per 100k residents MD Connecticut: 73 units · 2.0 per 100k residents CT Rhode Island: 30 units · 2.7 per 100k residents RI Arizona: 589 units · 7.9 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 90 units · 1.3 per 100k residents TN North Carolina: 828 units · 7.6 per 100k residents NC South Carolina: 677 units · 12.6 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 2,027 units · 44.3 per 100k residents LA Mississippi: no data reported MS Alabama: 21 units · 0.4 per 100k residents AL Georgia: 20 units · 0.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 930 units · 3.0 per 100k residents TX Florida: 377 units · 1.7 per 100k residents FL
Units reimbursed · per 100k residents
0.144.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 44.3 /100k
2 Kentucky 14.8 /100k
3 South Carolina 12.6 /100k
4 Arizona 7.9 /100k
5 North Carolina 7.6 /100k
6 Illinois 6.9 /100k
7 New York 5.7 /100k
8 Massachusetts 4.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Zelsuvmi — 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 Zelsuvmi. 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
$42.7K
Claims incl. refills
21
Beneficiaries
17
Spend / beneficiary
$2,513.96
Spend / claim
$2,035.11
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) ✓ Available
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) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 LNHC, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
LNHC, 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.
← 83786-0011-03 · LUPIN 83789-0434-00 · EK →
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.