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Ertaczo Sertaconazole Nitrate 20 mg/g Cream — NDC 73159-0004-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ertaczo Sertaconazole Nitrate 20 mg/g Cream — NDC 73159-004-60 (Billing 73159-0004-60)

by Lacer Pharma, LLC · 1 TUBE in 1 CARTON / 60 g in 1 TUBE

This is a package of Ertaczo Sertaconazole Nitrate 20 mg/g Cream from Lacer Pharma, LLC, marketed since Nov 2024 and currently FDA-listed. It is this product's only package size.

NDC 73159-0004-60
🏷️ FDA NDC (as labeled) 73159-004-60 billing pads the product segment with a zero
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 73159-004-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
73159 labeler · 004 product · 60 package
Package marketed since
Nov 26, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7315900460 2
Medicaid fills, this package
18,267 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) 73159-004-60
Product NDC 73159-004
11-digit billing NDC 73159000460
NCPDP billing unit GM — per gram (weight)
RxCUI 250511, 580294
UNII 1DV05410M5
Application # NDA021385
SPL Set ID 27d51f01-3282-34ea-e063-6394a90a91ed
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-11-26
Route TOPICAL
Dosage form CREAM
Substance SERTACONAZOLE NITRATE

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

GPI-14 90154070103720
GCN Seq No 030866
GCN 43590
HICL code 012849
Ingredient (HICL) Sertaconazole Nitrate
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 Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name ERTACZO 2% CREAM
FDB brand name Ertaczo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 030866
  • GCN: 43590
  • GPI-14 (Medi-Span): 90154070103720
  • HICL (First Databank): 012849
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 250511
Why two NDCs? The FDA registers this code as 73159-004-60 — 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 → 73159-0004-60. 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 Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Imidazole and triazole derivatives, Imidazole derivatives
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 ERTACZO 2% CREAM Ingredient Sertaconazole Nitrate
📖 What it is MedlinePlus · NLM

Sertaconazole is used to treat tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Sertaconazole is in a class of medications called imidazoles. It works by slowing the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats athlete’s foot between the toes (interdigital tinea pedis). Ertaczo is approved for healthy adults and children 12 and older when certain fungi cause the infection.
  • Apply it twice a day for 4 weeks. Cover the area between your toes and the healthy skin around it. If you just bathed, dry your feet well first. Wash your hands afterward and skip...
  • Please finish the full course your prescriber recommends. Symptoms can improve before the infection is fully treated.
  • Some people get skin irritation, dryness, burning, or tenderness where they apply it. If irritation develops, stop using it and call your doctor.
📖 Read our full Sertaconazole Topical guide →

Supplement & herbal interactions

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

Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $15.15 $908.98 / 60 g
Medicare drug plans payPart D · Q2 2026 $15.64 $938.61 / 60 g
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
73159-0004-60 You're viewing this Main listing 1 TUBE in 1 CARTON / 60 g in 1 TUBE 2024-11-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ertaczo 20 mg/gthis 73159-0004-60 Lacer 1 tube — — FDA listed —
Ertaczo 20 mg/g 85437-0004-60 Coral 1 tube — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Nov 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

🧪 Avoiding an ingredient? See Sertaconazole Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII FC72KVT52F
    A clear, viscous liquid derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in formulations like syrups, gels, and topical products.
  • UNII HYE7O27HAO
    Glyceryl isostearate is a fatty substance derived from vegetable oils or animal fats. In medicines, it acts as an emulsifier to blend water and oil components together, and helps form a smooth texture in creams, ointments, and other topical products.
  • UNII 0324G66D0E
    Glycol stearate is a waxy compound made by combining stearic acid with ethylene glycol. It acts as an emulsifier and thickener, helping keep oil and water mixed together smoothly in liquid or semi-solid medicines.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 33GX5WQC0M
    PEG-32 stearate is a synthetic compound made by combining polyethylene glycol (PEG) with stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, and may also serve as a solubilizer to improve how the active drug dissolves in the formulation.
  • UNII 8LQC57C6B0
    A synthetic compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients together, and also serves as a thickener in creams and lotions.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • 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.

9 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

LabelerLacer Pharma, LLC
Application holderLACER PHARMA LLC
FDA applicationNDA021385 (NDA)
Labeler code73159
First marketedNov 2024
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Lacer Pharma, LLC labeler code 73159

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 83 words ▾

1 INDICATIONS AND USAGE ERTACZO ® cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum , Trichophyton mentagrophytes, and Epidermophyton floccosum . ERTACZO cream, 2% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum .

( 1 )

⏱️ Dosage and Administration 120 words ▾

2 DOSAGE AND ADMINISTRATION Apply ERTACZO cream, 2% twice daily for 4 weeks. Apply a sufficient amount of ERTACZO cream, 2% to cover both the affected areas between the toes and the immediately surrounding healthy skin. Use ERTACZO cream, 2% for the full treatment time recommended by the physician, even though symptoms may have improved.

Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing. Wash hands after use. Avoid the use of occlusive dressings or wrappings.

For topical use. Not for ophthalmic, oral, or intravaginal use. Apply ERTACZO cream, 2% to the affected and immediate surrounding area(s) twice daily for 4 weeks.

( 2 ) Not for ophthalmic, oral, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream, 2%. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base. Cream, 2%. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 39 words ▾

5 WARNINGS AND PRECAUTIONS

5.1Local Adverse Reactions If irritation develops, discontinue treatment and institute appropriate therapy. Physicians should exercise caution when prescribing ERTACZO cream, 2%, to patients known to be sensitive to azole antifungals since cross-reactivity may occur.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lacer Pharma, LLC at 1-888-403-8874 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 clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving ERTACZO cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, and application site skin tenderness.

In a dermal sensitization trial, 8 of 202 evaluable subjects tested with ERTACZO cream, 2%, and 4 of 202 evaluable subjects tested with vehicle exhibited a erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of ERTACZO cream, 2%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on ERTACZO cream, 2% use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of sertaconazole nitrate to pregnant rats and rabbits during organogenesis at doses 40 and 80 times, respectively, the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison.

In rats, when maternal dosing was continued until weaning, a reduction in live birth indices and an increase in the number of still-born pups was observed at doses 20 and 40 times the MRHD based on BSA comparison ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss and other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Animal embryofetal development studies have not been conducted with ERTACZO cream, 2%. Embryofetal development studies performed in pregnant rats and rabbits administered oral doses of sertaconzaole nitrate up to 160 mg/kg/day (40 times [rats] and 80 times [rabbits] the MRHD based on a BSA comparison) during the period of organogenesis revealed no malformations or embryofetal developmental toxicity.

In a pre- and postnatal development study, pregnant rats were administered oral doses of sertaconazole nitrate from pregnancy day 6 to lactation day 20. A reduction in live birth indices and an increase in the number of still-born pups were seen at doses 20 and 40 times the MRHD based on BSA comparison.

8.2Lactation Risk Summary There are no data available on the presence of sertaconazole in human or animal milk, its effects on the breastfed infant, or its effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ERTACZO cream, 2% and any potential adverse effects on the breastfed infant from ERTACZO cream, 2% or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ERTACZO cream, 2%, have not been established in pediatric patients younger than 12 years of age.

8.5Geriatric Use Clinical trials of ERTACZO cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no available data on ERTACZO cream, 2% use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of sertaconazole nitrate to pregnant rats and rabbits during organogenesis at doses 40 and 80 times, respectively, the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison.

In rats, when maternal dosing was continued until weaning, a reduction in live birth indices and an increase in the number of still-born pups was observed at doses 20 and 40 times the MRHD based on BSA comparison ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss and other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Animal embryofetal development studies have not been conducted with ERTACZO cream, 2%. Embryofetal development studies performed in pregnant rats and rabbits administered oral doses of sertaconzaole nitrate up to 160 mg/kg/day (40 times [rats] and 80 times [rabbits] the MRHD based on a BSA comparison) during the period of organogenesis revealed no malformations or embryofetal developmental toxicity.

In a pre- and postnatal development study, pregnant rats were administered oral doses of sertaconazole nitrate from pregnancy day 6 to lactation day 20. A reduction in live birth indices and an increase in the number of still-born pups were seen at doses 20 and 40 times the MRHD based on BSA comparison.

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use The safety and effectiveness of ERTACZO cream, 2%, have not been established in pediatric patients younger than 12 years of age.

🧓 Geriatric Use 29 words ▾

8.5Geriatric Use Clinical trials of ERTACZO cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology 200 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sertaconazole nitrate is an azole antifungal [see Clinical Pharmacology (12.4) ] .

12.2Pharmacokinetics In a multiple-dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42 - 140 cm 2 ; mean, 93 cm 2 ), ERTACZO cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 g sertaconazole nitrate per 100 cm 2 ). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used.

12.3Microbiology Mechanism of Action Sertaconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. Ergosterol is a key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.

Activity In Vitro and in Clinical Infections Sertaconazole nitrate has been shown to be active against isolates of the following microorganisms in clinical infections [see Indications and Usage (1) ] : Trichophyton rubrum Trichophyton mentagrophytes Epidermophyton floccosum

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Sertaconazole nitrate is an azole antifungal [see Clinical Pharmacology (12.4) ] .

📦 How Supplied / Storage and Handling 46 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ERTACZO cream, 2%, is white in color and supplied in tubes in the following size: 60-gram tube NDC 73159-004-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 155 words ▾

11 DESCRIPTION ERTACZO (sertaconazole nitrate) cream, 2%, is for topical application. It contains the azole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.

Sertaconazole nitrate is designated chemically as (±)-1-[2,4-dichloro-β-[(7-chlorobenzo-[ b ]thien-3-yl)methoxy]phenethyl]imidazole nitrate. It has a molecular weight of 500.8. The molecular formula is C 20 H 15 Cl 3 N 2 OS ● HNO 3 , and the structural formula is as follows: Sertaconazole nitrate is a white or almost white powder.

It is practically insoluble in water, soluble in methanol, and sparingly soluble in alcohol and in methylene chloride. Each gram of ERTACZO cream, 2%, contains 17.5 mg of sertaconazole (as sertaconazole nitrate, 20 mg) in a white cream base of ethylene glycol, glyceryl isostearate, glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, purified water, and sorbic acid. Sertaconzole nitrate chemical structure

💬 Information for Patients 156 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct the patient of the following: Administration Instructions ERTACZO cream, 2% is for topical use only. Avoid contact with the eyes, mouth, vagina, and other mucous membranes.

Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing. Wash hands after use. Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved.

Avoid the use of occlusive dressings unless otherwise directed by the physician [see Dosage and Administration ( 2 )] . Local Adverse Reactions Inform the physician if the area of application shows signs of increased irritation, redness, itching, burning, blistering, swelling, or oozing [see Warnings and Precautions ( 5.1 )] . Distributed by: Lacer Pharma, LLC Biloxi, MS 39532 USA Manufactured by: DPT Laboratories, Ltd.

San Antonio, TX 78215 ERTACZO is a trademark of Lacer Pharma, LLC 141329

🧬 Pharmacokinetics 88 words ▾

12.2Pharmacokinetics In a multiple-dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42 - 140 cm 2 ; mean, 93 cm 2 ), ERTACZO cream, 2%, was topically applied every 12 hours for a total of 13 doses to the diseased skin (0.5 g sertaconazole nitrate per 100 cm 2 ). Sertaconazole concentrations in plasma measured by serial blood sampling for 72 hours after the thirteenth dose were below the limit of quantitation (2.5 ng/mL) of the analytical method used.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES In two randomized, double-blind clinical trials, subjects 12 years and older with interdigital tinea pedis applied either ERTACZO cream, 2%, or vehicle, twice daily for 4 weeks. Subjects with moccasin-type (plantar) tinea pedis and/or onychomycosis were excluded from the trial. Two weeks after completion of therapy (6 weeks after beginning therapy), subjects were evaluated for signs and symptoms related to interdigital tinea pedis.

Treatment outcomes are summarized in the table below. Treatment Outcomes as Percent (%) of Total Subjects with Interdigital Tinea Pedis Trial 1 Trial 2 Sertaconazole Vehicle Sertaconazole Vehicle Complete Cure* (Primary Efficacy Variable) 13/99 (13.1%) 3/92 (3.3%) 28/103 (27.2%) 5/103 (4.9%) Effective Treatment** 32/99 (32.3%) 11/92 (12.0%) 52/103 (50.5%) 16/103 (15.5%) Mycological Cure*** 49/99 (49.5%) 18/92 (19.6%) 71/103 (68.9%) 20/103 (19.4%) * Complete Cure – Patients who had complete clearing of signs and symptoms and Mycological Cure. ** Effective Treatment – Patients who had minimal residual signs and symptoms of interdigital tinea pedis and Mycological Cure. *** Mycological Cure – Patients who had both negative microscopic KOH preparation and negative fungal culture.

In clinical trials, complete cure in ERTACZO cream, 2%-treated subjects was achieved in 32 of 160 (20%) subjects with Trichophyton rubrum , in 7 of 28 (25%) subjects with Trichophyton mentagrophytes , and in 1 of 13 (15%) subjects with Epidermophyton floccosum .

🧪 Nonclinical Toxicology 127 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate doses of up to 800 mg/kg/day (200 times the MRHD based on a BSA comparison). No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was nonclastogenic in the in vivo mouse sister chromatid exchange assay.

There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures. Rats treated orally with up to 160 mg/kg/day of sertaconazole nitrate (40 times the MRHD based on a BSA comparison), exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 124 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year rat dermal carcinogenicity study, topical administration of sertaconazole nitrate cream did not increase the number of neoplastic lesions compared to control animals, at sertaconazole nitrate doses of up to 800 mg/kg/day (200 times the MRHD based on a BSA comparison). No clastogenic potential was observed in a mouse micronucleus test. Sertaconazole nitrate was nonclastogenic in the in vivo mouse sister chromatid exchange assay.

There was no evidence that sertaconazole nitrate induced unscheduled DNA synthesis in primary rat hepatocyte cultures. Rats treated orally with up to 160 mg/kg/day of sertaconazole nitrate (40 times the MRHD based on a BSA comparison), exhibited no toxicity or adverse effects on reproductive performance or fertility in male or female rats.

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert PATIENT INFORMATION ERTACZO ® (er-tack-zo) (sertaconazole nitrate) cream Important information: ERTACZO cream is for use on skin only. Do not use ERTACZO cream in your eyes, mouth, or vagina. What is ERTACZO cream?

ERTACZO cream is a prescription medicine used on the skin (topical) to treat athlete’s foot that is between the toes (interdigital tinea pedis) in adults and children 12 years of age and older with normal immune systems. It is not known if ERTACZO cream is safe and effective in children younger than 12 years of age. Before using ERTACZO cream, tell your healthcare provider about all of your medical conditions, including if you: have any allergies are pregnant or plan to become pregnant.

It is not known if ERTACZO cream will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ERTACZO cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ERTACZO cream.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ERTACZO cream? Use ERTACZO cream exactly as your healthcare provider tells you to use it.

Use ERTACZO cream for the full treatment time, even if your symptoms improve. If you take a bath or shower, dry the affected skin areas well before you apply ERTACZO cream. Apply ERTACZO cream 2 times a day for 4 weeks to the affected skin areas between your toes and to the healthy skin around the affected areas.

Wash your hands after you apply ERTACZO cream. Do not cover the treated skin areas with bandages unless your healthcare provider tells you to. What are the possible side effects of ERTACZO cream?

The most common side effects of ERTACZO cream include: redness, itching, dry skin, burning, blistering, swelling, drainage, and skin tenderness at the treated skin areas. Tell your healthcare provider if you have any of these skin reactions. These are not all the possible side effects of ERTACZO cream.

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 ERTACZO cream?

Store ERTACZO cream at room temperature between 68°F to 77°F (20°C to 25°C). Keep ERTACZO cream and all medicines out of reach of children. General information about the safe and effective use of ERTACZO cream Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

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

You can ask your healthcare provider or pharmacist for information about ERTACZO cream that is written for health professionals. What are the ingredients in ERTACZO cream? Active ingredient: sertaconazole nitrate Inactive ingredients: ethylene glycol, glyceryl isostearate, glycolized saturated glycerides, light mineral oil, methylparaben, polyethylene glycol palmitostearate, polyoxyethylened saturated glycerides, purified water, and sorbic acid Distributed by: Lacer Pharma, LLC Biloxi, MS 39532 USA Manufactured by: DPT Laboratories, Ltd.

San Antonio, TX 78215 ERTACZO is a trademark of Lacer Pharma, LLC 141329 This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 04/2024

📄 Package Label / Principal Display Panel 38 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 60 g Carton NDC 0187-5115-60 ERTACZO ® (sertaconazole nitrate) cream, 2% Rx only For Topical Use Only - Not for Ophthalmic, Oral, or Intravaginal Use Net Wt. 60 g Tube Image Carton Image

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 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
18.3K
Units reimbursed last 4 qtrs
1.1M
Gross reimbursed last 4 qtrs
$16.56M
Avg / prescription
$906.30
Avg / unit
$15.1496
Latest quarter Q1 2026
6.2KRx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 18,267 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,085,532 units · 5,547 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 5,700 units · 97.0 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 1,560 units · 30.5 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
30.55,547
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 New York 5,547 /100k
2 Colorado 97.0 /100k
3 Alabama 30.5 /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 Ertaczo — 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 Ertaczo. 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
$2.15M
Claims incl. refills
1.9K
Beneficiaries
1.2K
Spend / beneficiary
$1,860.26
Spend / claim
$1,163.42
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ertaczo (this brand).

Top reported reactions

Fatigue15
Urethral Valves14
Fall13
Rash11
Asthenia10
Gait Disturbance10
Weight Decreased10

Age at onset

Adolescent1
Adult23
Elderly10

Reporter sex

156 reports
Male · 46%
Female · 54%

Serious outcomes

Death21
Life-threatening7
Disabling6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 27 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — 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

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 Lacer Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lacer Pharma, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 73154-0130-14 · Ardelyx, 73159-0008-60 · Lacer →
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.