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Tagrit Antifungal Treament Ketoconazole 1% 10 mg/1000g Cream, 100 g — NDC 85384-0002-01 package photo

Tagrit Antifungal Treament Ketoconazole 1% 10 mg/1000g Cream, 100 g

by TAGRID LLC · 100 g in 1 TUBE (85384-0002-1)
NDC 85384-0002-01
🏷️ FDA NDC (as labeled) 85384-0002-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 85384-0002-1
Product NDC 85384-0002
11-digit billing NDC 85384000201
UNII R9400W927I
Application # M005
SPL Set ID 315a8832-c42f-c07a-e063-6394a90a8218
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 OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-18
Route TOPICAL
Dosage form CREAM
Substance KETOCONAZOLE
Why two NDCs? The FDA registers this code as 85384-0002-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 85384-0002-01. 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.

🏭 Manufacturer & labeler

LabelerTAGRID LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85384
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio24 products on file
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

📗 Our plain-language guide HelloPharmacist
  • Tinea versicolor is a fungal infection caused by a yeast that normally lives on everyone's skin. When it overgrows, it creates light or dark patches — most commonly on the chest, b...
  • What exactly is tinea versicolor, and will this clear it up completely?
  • The key is to never dispense it directly onto your hands — the foam starts melting the moment it hits warm skin. Instead, press the nozzle into the cap of the can or any cool surfa...
  • How do I actually apply this foam without making a mess?
📖 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.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 2JYC99Q0WZ
    A plant extract from Artemisia argyi, commonly known as mugwort. It may be used as a flavoring agent, fragrance, or traditional botanical ingredient in some formulations.
  • UNII 04W97Z676Y
    A plant-derived natural substance from Bassia scoparia fruit used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping in the tablet or capsule.
  • UNII 07A108ZKW5
    Bassia scoparia pollen is a natural plant-derived substance used as a filler or bulking agent in medications. It helps add volume and texture to tablets or capsules while remaining inert in the formulation.
  • UNII M89NIB437X
    Borneol is a waxy, plant-derived alcohol obtained from camphor trees or made synthetically. It's used in medicines as a flavoring agent and penetration enhancer to improve how active ingredients are absorbed.
  • UNII V1IA3S3CUS
    A plant extract derived from Cnidium monnieri fruit, commonly used in traditional Asian medicine preparations. In formulations, it may serve as an active botanical ingredient or flavoring agent, though its specific role depends on the product type.
  • UNII LA97176ILS
    A plant-derived ingredient from the root bark of Dictamnus dasycarpus. It may function as a natural extract or traditional ingredient to support formulation stability or consistency in herbal preparations.
  • UNII H51N91QNEB
    A plant extract from the smilax glabra vine used in traditional medicine preparations. It may function as a natural flavoring agent, botanical extract, or ingredient to support the product's intended formulation characteristics.
  • UNII IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.

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

The official label also statesBorneol Sophora Flavescens Root Cnidium monnieri Root Bassia scoparia Fruit Scoparia Pollen Dictamnus Dasycarpus Root Smilax Glabra Whole Artemisia argyi Leaf Tea Tree Oil

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

💲 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tagrit Antifungal Treament Ketoconazole 1% 10 mg/1000gthis 85384-0002-01 TAGRID 100 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
Apr 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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

Medicare Part D (outpatient prescription) spending for Ketoconazole (matched by generic name) — 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. CMS lists 2 products for this generic; we show the highest-spend one. 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85384-0002-01 You're viewing this 100 g in 1 TUBE (85384-0002-1) 2025-04-18 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 FDA registers it as 85384-0002-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85384-0002-01, written without dashes as 85384000201. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 85384-0002-01, the first segment (85384) is the labeler code FDA assigned to TAGRID LLC; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 TAGRID LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TAGRID 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 71 words ▾

Treats fungal infections of the skin, such as folliculitis, athlete's foot, jock itch, ringworm, and seborrheic dermatitis. Effective for relieving symptoms of itching, scaling, redness, and discomfort caused by fungal infections. Helps reduce and control fungal skin infections, including tinea corporis (body fungus), tinea cruris (groin fungus), tinea pedis (foot fungus), and tinea versicolor.

Can be used on areas prone to fungal growth, such as the scalp,face,chest, back, arms, and legs.

⏱️ Dosage and Administration 59 words ▾

Directions 1. Adults and children 12 years and over: Clean and dry the affected area before application. Apply a small amount to the affected area once or twice daily, or as directed by a doctor. Use continuously for up to 4 weeks, or as directed by a healthcare provider. 2. Children under 12 years: Ask a doctor before use.

⚠️ Warnings 80 words ▾

For external use only. on broken, inflamed, or severely irritated skin. lf you are allergic to Ketoconazole or any other ingredients in this product. Avoid contact with the eyes. If the product gets into the eyes, rinse thoroughly with water.

Stop use and ask a doctor if: a rash appears. the condition does not improve within 2-4 weeks of regular use. ask a healthcare provider before use. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 2 words ▾

Ketoconazole 1%

🧪 Inactive Ingredients 24 words ▾

Borneol Sophora Flavescens Root Cnidium monnieri Root Bassia scoparia Fruit Scoparia Pollen Dictamnus Dasycarpus Root Smilax Glabra Whole Artemisia argyi Leaf Tea Tree Oil

🎯 Purpose 2 words ▾

Antifungal Ointment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85384-0001-01 · TAGRID 85384-0003-01 · TAGRID →
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.