NDC 45802-0138-11 — Ciclopirox olamine 7.7 mg/g Cream

🆔 Identity & classification

FDA NDC (as labeled) 45802-138-11

Product NDC 45802-138

11-digit billing NDC 45802013811

NCPDP billing unit GM — per gram (weight)

RxCUI 309289

UNII 50MD4SB4AP

Application # ANDA077364

SPL Set ID 1a74ed86-997a-4b86-b54a-b2b2c94e8abb

Mechanism of action Protein Synthesis Inhibitors

Physiologic effect Decreased DNA Replication; Decreased Protein Synthesis; Decreased RNA Replication

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2006-07-19

Route TOPICAL

Dosage form CREAM

Substance CICLOPIROX OLAMINE

GCN Seq No 040971

GCN 94677

HICL code 003203

Ingredient (HICL) Ciclopirox Olamine

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 84:04.08.20

AHFS class Hydroxypyridones (Skin, Mucous Membrane)

FDB label name CICLOPIROX 0.77% CREAM

FDB brand name Ciclopirox

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 45802-138-11 — 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 → 45802-0138-11. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Other antifungals for topical use class.

Drug family (ATC) Other antifungals for topical use, Other antiinfectives and antiseptics

How it works Protein Synthesis Inhibitors

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.

🏭 Manufacturer & labeler

LabelerPadagis Israel Pharmaceuticals Ltd

Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD

FDA applicationANDA077364 (ANDA)

Labeler code45802

First marketedJul 2006

Product typeHuman Prescription Drug

Portfolio175 products on file

🔎 All NDCs from Padagis Israel Pharmaceuticals Ltd

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.

🩺 Clinical

Label name CICLOPIROX 0.77% CREAM Ingredient Ciclopirox Olamine

📗 Our plain-language guide HelloPharmacist

It's treating a fungal infection living inside your nail. Ciclodan (the 8% nail lacquer solution) works specifically on onychomycosis — a fungal infection of the nail plate caused...
What is this medicine actually treating — my nail or a skin infection?
Nail infections are slow to treat because nails grow slowly. Clinical studies used ciclopirox nail lacquer for 48 weeks — that's nearly a year. Even then, complete clearing of the...
How long will I have to use this before I see results?

📖 Read our full Ciclopirox Topical guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

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.

💲 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 system	Per g	Per package
Retail pharmacies payNADAC · weekly	$0.169	$5.06 / 30 g
Medicaid paysCMS SDUD · 12 mo	$0.3291	$9.87 / 30 g
Medicare drug plans payPart D · Q2 2026	$0.3074	$9.22 / 30 g

NADAC price history (per g) — tap or hover for the price & month

▼ Down 13% over the last 24 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ciclopirox olamine 7.7 mg/gthis 45802-0138-11	Padagis	1 tube	$0.169	AB	Availability likely	—
Ciclopirox Olamine 7.7 mg/g 00713-0638-15	Cosette	1 tube	$0.208	AB	Availability likely	+23%
Ciclopirox Olamine 7.7 mg/g 51672-1318-01	Sun	1 tube	$0.208	AB	Availability likely	+23%
Ciclopirox Olamine 7.7 mg/g 68462-0297-17	Glenmark	15 g	$0.208	AB	Availability likely	+23%
Ciclopirox Olamine 7.7 mg/g 63629-8624-01	Bryant	1 tube	—	AB	FDA listed	—
Ciclopirox Olamine 7.7 mg/g 63629-8625-01	Bryant	1 tube	—	AB	FDA listed	—
Ciclopirox olamine 7.7 mg/g 63629-8626-01	Bryant	1 tube	—	AB	FDA listed	—
Ciclopirox olamine 7.7 mg/g 71335-2865-01	Bryant	1 tube	—	AB	FDA listed	—
Ciclopirox Olamine 7.7 mg/g 72162-1397-02	Bryant	1 tube	—	AB	FDA listed	—
Ciclopirox Olamine 7.7 mg/g 80425-0225-01	Advanced	30 g	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2006

On the market since

Jul 2006

📍

2026

Currently FDA-listed

20 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ 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 45802-0138-11, 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

9K

Units reimbursed last 4 qtrs

389.6K

Gross reimbursed last 4 qtrs

$128.2K

Avg / prescription

$14.22

Avg / unit

$0.3291

Latest quarter Q1 2026

2.1KRx

Medicaid pays / g

$0.3291

gross reimbursed

vs

NADAC / g

$0.1687

acquisition cost

=

Spread

+$0.1604

+95% 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 ⓘ

55% FFS 45% MCO

Fee-for-service · 4,991 Rx Managed care · 4,023 Rx

State Medicaid map

Units reimbursed · per 100k residents

3.9533

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 Hawaii 533 /100k

2 D.C. 402 /100k

3 California 358 /100k

4 New York 346 /100k

5 Florida 296 /100k

6 New Jersey 202 /100k

7 Mississippi 131 /100k

8 Washington 113 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 tube this page45802-0138-11 9,014 Rx · $128,201

1 tube45802-0138-18 6,128 Rx · $119,627

1 tube45802-0138-35 1,340 Rx · $14,248

Drug total (last 4 qtrs): 16,482 Rx · 982,177 units · $262,076 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Ciclopirox (matched by generic name) — the program that covers self-administered drugs. 6 manufacturers.

⚠️ 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 Ciclopirox. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$3.34M

Claims incl. refills

125.3K

Beneficiaries

93.6K

Spend / beneficiary

$35.64

Spend / claim

$26.62

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 Ciclopirox Olamine — the ingredient across all brands.

Top reported reactions

Device Dislocation78

Device Malfunction78

Rash25

Fatigue22

Pruritus21

Condition Aggravated17

Pain17

Age at onset

Adult50

Elderly25

Reporter sex

Male · 61%

Female · 39%

Unknown · 1%

Serious outcomes

Hospitalization200

Life-threatening37

Disabling26

Reports over time (by year) — tap or hover for the count & year

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
45802-0138-11 You're viewing this	1 TUBE in 1 CARTON (45802-138-11) / 30 g in 1 TUBE	$0.1687 / g	$5.06	2006-07-19	Active
45802-0138-18	1 TUBE in 1 CARTON (45802-138-18) / 90 g in 1 TUBE	$0.1025 / g	$9.23	2006-12-14	Active
45802-0138-35	1 TUBE in 1 CARTON (45802-138-35) / 15 g in 1 TUBE	$0.2077 / g	$3.11	2006-09-05	Active

Per g, this pack runs about 65% above the cheapest pack (NDC 45802-0138-18, $0.1025 vs $0.1687 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 55% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 45802-0138-11?

NDC 45802-0138-11 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.

What NDC number is used to bill for this package of Ciclopirox olamine 7.7 mg/g Cream?

Bill NDC 45802-0138-11 — the 11-digit billing format is 45802013811. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 49 words ▾

INDICATIONS AND USAGE Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

⏱️ Dosage and Administration 75 words ▾

DOSAGE AND ADMINISTRATION Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream, the diagnosis should be redetermined.

Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

⚠️ Warnings 15 words ▾

WARNINGS Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.

🤒 Adverse Reactions 92 words ▾

ADVERSE REACTIONS In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 years have not been established.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Ciclopirox is a hydroxypyridone antifungal agent that acts by chelation of polyvalent cations (Fe 3+ or Al 3+ ), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. Pharmacokinetics Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm 2 on the back followed by occlusion for 6 hours.

The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible.

Penetration studies in human cadaverous skin from the back, with ciclopirox olamine cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations. Autoradiographic studies with human cadaverous skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum.

Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to ciclopirox olamine cream.

📦 How Supplied / Storage and Handling 32 words ▾

HOW SUPPLIED Ciclopirox Olamine Cream USP, 1.0% is available as follows: 15 g tube (NDC 45802- 138 -35) 30 g tube (NDC 45802- 138 -11) 90 g tube (NDC 45802- 138 -18)

📦 Storage and Handling 32 words ▾

STORAGE Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 03-26 3D914 RC I PH3 PADAGIS is a registered trademark of Padagis US LLC.

📋 Description 111 words ▾

DESCRIPTION Ciclopirox Olamine Cream USP, 1.0% is for topical use. Each gram of ciclopirox olamine cream contains 10 mg of ciclopirox olamine equivalent to 7.70 mg of ciclopirox in a water miscible vanishing cream base consisting of benzyl alcohol NF, cetyl alcohol NF, lactic acid USP, light mineral oil NF, myristyl alcohol NF, octyldodecanol NF, polysorbate 60 NF, purified water USP, sorbitan monostearate NF, and stearyl alcohol NF. Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine).

The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is: Ciclopirox olamine cream has a pH of 7.

Chemical Structure Image

💬 Information for Patients 70 words ▾

Information for Patients The patient should be told to: 1. Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks. 2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization. 3. Avoid the use of occlusive wrappings or dressings.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

broad-spectrum: Describes an antibiotic that works against a wide range of different bacteria.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

pruritus: Itching of the skin.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

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

🔗 Related NDC lookups

🧪 All Ciclopirox Olamine NDCsSame ingredient 🏭 All Padagis labeler NDCsLabeler code 45802 📖 Read the Ciclopirox Olamine drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Antifungals.

Nystatin/Triamcinolone Acet 00168-0081-15 Miconazole Nitrate 00316-0225-15 Gentian Violet 00395-1003-92 Tolnaftate 00536-1315-43

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.