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Ketoconazole 20 mg/mL Shampoo, Suspension, 120 mL — NDC 72603-0878-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ketoconazole 20 mg/mL Shampoo, Suspension, 120 mL — NDC 72603-878-01 (Billing 72603-0878-01)

by Northstar Rx LLC · 120 mL in 1 BOTTLE

This is a package of 120 mL of Ketoconazole 20 mg/mL Shampoo, Suspension from Northstar Rx LLC, marketed since Dec 2025 and currently FDA-listed; retail pharmacies pay about $0.0754 per mL (NADAC). It is this product's only package size.

NDC 72603-0878-01
🏷️ FDA NDC (as labeled) 72603-878-01 billing pads the product segment with a zero
Rx only Generic 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 72603-878-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72603 labeler · 878 product · 01 package
Package marketed since
Dec 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
120 mL per package
Barcode (UPC-A, from the NDC)
3 7260387801 1
Medicaid fills, this package
10,985 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) 72603-878-01
Product NDC 72603-878
11-digit billing NDC 72603087801
NCPDP billing unit ML — per mL (volume)
RxCUI 106336
UNII R9400W927I
Application # ANDA076419
SPL Set ID c4f711dc-d0ea-4beb-9a78-b7e3594ee4be
Established class (EPC) Azole Antifungal
Mechanism of action Cytochrome P450 3A4 Inhibitors; Cytochrome P450 3A5 Inhibitors; P-Glycoprotein Inhibitors
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-01
Route TOPICAL
Dosage form SHAMPOO, SUSPENSION
Substance KETOCONAZOLE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90154045004510
GCN Seq No 015568
GCN 31271
HICL code 004132
Ingredient (HICL) Ketoconazole
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 08:14.08.00
AHFS class Azole Antifungals
FDB label name KETOCONAZOLE 2% SHAMPOO
FDB brand name Ketoconazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 015568
  • GCN: 31271
  • GPI-14 (Medi-Span): 90154045004510
  • HICL (First Databank): 004132
  • AHFS class code: 08:14.08.00
  • RxCUI (RxNorm): 106336
Why two NDCs? The FDA registers this code as 72603-878-01 — 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 → 72603-0878-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cortisol Synthesis Inhibitor class.

Pharmacologic class Cortisol Synthesis Inhibitor, Azole Antifungal
Drug family (ATC) Anticorticosteroids, Imidazole and triazole derivatives, Imidazole derivatives
How it works Cytochrome P450 2B6 Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 17A1 Inhibitors, P-Glycoprotein 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.

Clinical

Label name KETOCONAZOLE 2% SHAMPOO Ingredient Ketoconazole
📗 Our plain-language guide HelloPharmacist
  • It depends on the form. The tablets treat serious fungal infections like blastomycosis and histoplasmosis. The creams, foam and shampoos treat skin and scalp conditions like ringwo...
  • Take them with a meal, since that helps your body absorb them best. Follow your prescriber's directions. If you take acid-reducing medicine, ask me how to time it, because it can l...
  • Nausea, stomach upset, headache and dizziness are among the more common ones. Call your doctor right away if you notice yellow skin or eyes, dark urine, unusual tiredness, fainting...
  • The tablets have caused serious liver injury, sometimes fatal, even in people with no known liver problems. That's why you'll have liver blood tests before and during treatment. Av...
📖 Read our full Ketoconazole guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.075 $9.05 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.1451 $17.41 / 120 ml
Medicare drug plans payPart D · Q2 2026 $0.1120 $13.44 / 120 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2026 Mar 2026 Jun 2026 Sep 2026 $0.083 $0.075
▼ Down 9% over the last 9 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
72603-0878-01 You're viewing this Main listing 120 mL in 1 BOTTLE 2025-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ketoconazole 20 mg/mL 00713-0592-04 Cosette 120 ml $0.075 AB Availability likely —
Ketoconazole 20 mg/mL 45802-0465-64 Padagis 120 ml $0.075 AB Availability likely —
Ketoconazole 20 mg/mL 63646-0010-04 TOLMAR 120 ml $0.075 AB Discontinued —
Ketoconazole 20 mg/mL 70954-0662-10 ANI 120 ml $0.075 AB Availability likely —
Ketoconazole 20 mg/mL 72578-0156-12 Viona 120 ml $0.075 AB Availability likely —
Ketoconazole 20 mg/mLthis 72603-0878-01 Northstar 120 ml $0.075 AB Availability likely —
Ketoconazole 20 mg/mL 50090-3288-00 A-S 118.28 ml — AB FDA listed —
Ketoconazole 20 mg/mL 50090-7538-00 A-S 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 63629-8675-01 Bryant 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 68071-3930-04 NuCare 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 68071-5294-04 NuCare 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 68788-8257-01 Preferred 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 68788-8868-01 Preferred 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 70771-1874-07 Zydus 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 71205-0105-72 Proficient 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 71335-2839-01 Bryant 120 ml — AB FDA listed —
Ketoconazole 20 mg/mL 71713-0097-04 THIRTY 120 ml — AB Discontinued —
Ketoconazole 20 mg/mL 72162-1409-02 Bryant 120 ml — 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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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.

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 Ketoconazole 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.

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.

Manufacturer & labeler

LabelerNorthstar Rx LLC
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA076419 (ANDA)
Labeler code72603
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio414 products on file

More NDCs from Northstar Rx LLC labeler code 72603

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 ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 120 words ▾

INDICATIONS AND USAGE Ketoconazole Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites.

Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

⏱️ Dosage and Administration 42 words ▾

DOSAGE AND ADMINISTRATION Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water. One application of the shampoo should be sufficient.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Ketoconazole Shampoo, 2% is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Clinical Trials Experience In 11 double-blind trials in 264 patients using ketoconazole shampoo, 2% for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported.

In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of ketoconazole shampoo, 2% (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups.

Post-marketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. The following adverse drug reactions have been identified during post-marketing experience with ketoconazole shampoo, 2%: there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.

🤰 Pregnancy 99 words ▾

Pregnancy: Teratogenic effects: Pregnancy Category C - There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp.

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

🧒 Pediatric Use 11 words ▾

Pediatric Use- Safety and effectiveness in children have not been established.

🆘 Overdosage 35 words ▾

OVERDOSAGE Ketoconazole Shampoo, 2% is intended for external use only. In the event of accidental ingestion, supportive and symptomatic measures should be employed. Induced emesis and gastric lavage should not be performed to avoid aspiration.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum orbiculare ( Malassezia furfur ). This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs.

Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable.

Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months). An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of ketoconazole shampoo, 2% was significantly less than that of 2.5% selenium sulfide shampoo. A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity and no photoallergenic potential due to ketoconazole shampoo, 2%.

Mode of Action- Interpretations of in vivo studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated, but not proven, that the therapeutic effect of ketoconazole in tinea (pityriasis) versicolor is due to the reduction of Pityrosporum orbiculare ( Malassezia furfur ) and that the therapeutic effect in dandruff is due to the reduction of Pityrosporum ovale. Support for the therapeutic effect in tinea versicolor comes from a three-arm, parallel, double-blind, placebo controlled study in patients who had moderately severe tinea (pityriasis) versicolor.

Successful response rates in the primary efficacy population for each of both three-day and single-day regimens of ketoconazole shampoo, 2% were statistically significantly greater (73% and 69%, respectively) than a placebo regimen (5%). There had been mycological confirmation of fungal disease in all cases at baseline. Mycological clearing rates were 84% and 78%, respectively, for the three-day and one-day regimens of the 2% shampoo and 11% in the placebo regimen.

While the differences in the rates of successful response between either of the two active treatments and placebo were statistically significant, the difference between the two active regimens was not. Microbiology- Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, C. tropicalis, Pityrosporum ovale ( Malassezia ovale ) and Pityrosporum orbiculare ( M. furfur ) .

Development of resistance by these microorganisms to ketoconazole has not been reported.

📦 How Supplied / Storage and Handling 26 words ▾

HOW SUPPLIED Ketoconazole Shampoo, 2% is a red-orange liquid and is available as follows: 4 fl. oz. (120 mL) nonbreakable plastic bottle (NDC 72603- 878 -01)

📦 Storage and Handling 17 words ▾

STORAGE Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light.

📋 Description 81 words ▾

DESCRIPTION Ketoconazole Shampoo, 2% is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty acid diethanolamide, disodium laureth sulfosuccinate, FD & C Red No. 40, hydrochloric acid, imidurea, laurdimonium hydroxypropyl hydrolyzed collagen, PEG-120 methyl glucose dioleate, purified water, sodium chloride, sodium hydroxide, and sodium lauryl ether sulfate.

Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]piperazine and has the following structural formula: Chemical Structure

💬 Information for Patients 107 words ▾

Information for Patients- Patients should be advised of the following: • Ketoconazole Shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided. • The following have been reported with the use of ketoconazole shampoo, 2%: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. • Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, angioedema, or shortness of breath should discontinue Ketoconazole Shampoo, 2% and contact their physician immediately.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of ketoconazole shampoo, 2%. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Information for Patients- Patients should be advised of the following: • Ketoconazole Shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided. • The following have been reported with the use of ketoconazole shampoo, 2%: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. • Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, angioedema, or shortness of breath should discontinue Ketoconazole Shampoo, 2% and contact their physician immediately.

Carcinogenesis, Mutagenesis, Impairment of Fertility- Long-term studies to assess the carcinogenic potential of ketoconazole shampoo, 2% have not been conducted. A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg were not genotoxic.

The Ames Salmonella microsomal activator assay was also negative. Pregnancy: Teratogenic effects: Pregnancy Category C - There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp. Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

Nursing Mothers- There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when Ketoconazole Shampoo, 2% is administered to a nursing woman.

Pediatric Use- Safety and effectiveness in children have not been established.

🍼 Nursing Mothers 38 words ▾

Nursing Mothers- There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when Ketoconazole Shampoo, 2% is administered to a nursing woman.

🔬 Clinical Studies 180 words ▾

Clinical Trials Experience In 11 double-blind trials in 264 patients using ketoconazole shampoo, 2% for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported.

In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of ketoconazole shampoo, 2% (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 74 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility- Long-term studies to assess the carcinogenic potential of ketoconazole shampoo, 2% have not been conducted. A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg were not genotoxic.

The Ames Salmonella microsomal activator assay was also negative.

📄 Package Label / Principal Display Panel 18 words ▾

Package/Label Display Panel NDC 72603-878-01 Rx Only Ketoconazole Shampoo, 2% For Topical Application Only 4 FL OZ front-label

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.
📅 Q4 2025 – Q1 2026 · 2 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
11K
Units reimbursed last 4 qtrs
1.4M
Gross reimbursed last 4 qtrs
$198.1K
Avg / prescription
$18.03
Avg / unit
$0.1451
Latest quarter Q1 2026
11KRx
Medicaid pays / mL
$0.1451
gross reimbursed
vs
NADAC / mL
$0.0754
acquisition cost
=
Spread
+$0.0697
+92% vs cost
What Medicaid paid per mL (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 ⓘ
44% FFS 56% MCO
Fee-for-service · 4,795 Rx Managed care · 6,190 Rx
State Medicaid map
Alaska: 4,200 units · 573 per 100k residents AK Maine: 1,800 units · 129 per 100k residents ME Washington: 251,221 units · 3,216 per 100k residents WA Idaho: 21,840 units · 1,112 per 100k residents ID Montana: 16,920 units · 1,495 per 100k residents MT North Dakota: 2,040 units · 261 per 100k residents ND Minnesota: 18,360 units · 320 per 100k residents MN Wisconsin: 31,440 units · 532 per 100k residents WI Michigan: 52,110 units · 519 per 100k residents MI New York: 147,000 units · 751 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 81,360 units · 1,922 per 100k residents OR Nevada: 17,280 units · 541 per 100k residents NV Wyoming: 1,440 units · 247 per 100k residents WY South Dakota: 1,680 units · 183 per 100k residents SD Iowa: 5,032 units · 157 per 100k residents IA Illinois: 61,560 units · 491 per 100k residents IL Indiana: 4,920 units · 71.7 per 100k residents IN Ohio: 32,040 units · 272 per 100k residents OH Pennsylvania: 14,160 units · 109 per 100k residents PA New Jersey: 11,760 units · 127 per 100k residents NJ Massachusetts: 17,400 units · 249 per 100k residents MA California: 247,473 units · 635 per 100k residents CA Utah: 6,000 units · 176 per 100k residents UT Colorado: 27,840 units · 474 per 100k residents CO Nebraska: 11,640 units · 588 per 100k residents NE Missouri: 24,120 units · 389 per 100k residents MO Kentucky: 20,160 units · 445 per 100k residents KY West Virginia: 4,080 units · 231 per 100k residents WV Virginia: 3,960 units · 45.4 per 100k residents VA Maryland: 33,600 units · 544 per 100k residents MD Connecticut: 5,640 units · 156 per 100k residents CT Rhode Island: 1,920 units · 175 per 100k residents RI Arizona: 26,160 units · 352 per 100k residents AZ New Mexico: 11,520 units · 545 per 100k residents NM Kansas: no data reported KS Arkansas: 20,278 units · 661 per 100k residents AR Tennessee: 8,400 units · 118 per 100k residents TN North Carolina: 7,920 units · 73.1 per 100k residents NC South Carolina: 2,520 units · 46.9 per 100k residents SC Delaware: 3,120 units · 303 per 100k residents DE Oklahoma: 11,401 units · 281 per 100k residents OK Louisiana: 16,920 units · 370 per 100k residents LA Mississippi: 13,920 units · 473 per 100k residents MS Alabama: 13,680 units · 268 per 100k residents AL Georgia: 5,160 units · 46.8 per 100k residents GA D.C.: 7,560 units · 1,113 per 100k residents DC Hawaii: 4,560 units · 318 per 100k residents HI Texas: 16,920 units · 55.5 per 100k residents TX Florida: 12,960 units · 57.3 per 100k residents FL
Units reimbursed · per 100k residents
45.43,216
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 Washington 3,216 /100k
2 Oregon 1,922 /100k
3 Montana 1,495 /100k
4 D.C. 1,113 /100k
5 Idaho 1,112 /100k
6 New York 751 /100k
7 Arkansas 661 /100k
8 California 635 /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 Ketoconazole — the program that covers self-administered drugs. 13 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 Ketoconazole. 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
$20.47M
Claims incl. refills
1.2M
Beneficiaries
831.7K
Spend / beneficiary
$24.61
Spend / claim
$17.69
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.
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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.