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Ketoconazole 20 mg/g Cream — NDC 71085-008-60 (Billing 71085-0008-60)

by IPG PHARMACEUTICALS, INC. · 1 TUBE in 1 CARTON / 60 g in 1 TUBE

This is a package of Ketoconazole 20 mg/g Cream from IPG PHARMACEUTICALS, INC., marketed since Sep 2026 and currently FDA-listed; retail pharmacies pay about $0.1853 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 71085-0008-60
🏷️ FDA NDC (as labeled) 71085-008-60 billing pads the product segment with a zero
This package
Contains60 g in 1 tube Cost per g$0.1853 NADAC Per package$11.12 / 60 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3497/unit — full pricing hub ↓
Main listing for product 71085-008 · Also comes in: 45 g 71085-008-45
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 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 71085-008-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71085 labeler · 008 product · 60 package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7108500860 2
Medicaid fills, this package
83 prescriptions in the last four reported quarters
FDA record last changed
Sep 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71085-008-60
Product NDC 71085-008
11-digit billing NDC 71085000860
NCPDP billing unit GM — per gram (weight)
Application # ANDA075638
SPL Set ID 5bc5a7b0-f5db-91b4-e063-6294a90aeeb1
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 2026-09-10
Route TOPICAL
Dosage form CREAM
Substance KETOCONAZOLE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 007334
GCN 31850
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% CREAM
FDB brand name Ketoconazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007334
  • GCN: 31850
  • HICL (First Databank): 004132
  • AHFS class code: 08:14.08.00
Why two NDCs? The FDA registers this code as 71085-008-60 — 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 → 71085-0008-60. 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.

Clinical

Label name KETOCONAZOLE 2% CREAM Ingredient Ketoconazole
📖 What it is MedlinePlus · NLM

Ketoconazole cream is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes), tinea versicolor (fungal infection of the skin that causes brown or light colored spots on the chest, back, arms, legs, or neck), and yeast infections of the skin. Prescription ketoconazole shampoo is used to treat tinea versicolor. Over-the-counter ketoconazole shampoo is used t...

Read the full MedlinePlus article ↗
📗 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 gPer package
Retail pharmacies payNADAC · weekly $0.185 $11.12 / 60 g
Medicaid paysCMS SDUD · 12 mo $0.3497 $20.98 / 60 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Jan 2026 Feb 2026 $0.188 $0.184
▼ Down 1% over the last 3 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 Per unit Per pack Marketing startMarketing endStatus
71085-0008-60 You're viewing this Main listing 1 TUBE in 1 CARTON / 60 g in 1 TUBE $0.1853 / g $11.12 2016-12-21 — Active
71085-0008-45 71085-008-45 1 TUBE in 1 CARTON / 45 g in 1 TUBE — — 2026-09-10 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 60 g in 1 tube.
What NDC number is used to bill for this package of Ketoconazole 20 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ketoconazole 20 mg/gthis 71085-0008-60 IPG 1 tube $0.185 AB FDA listed —
Ketoconazole 20 mg/g 00093-3219-15 Teva 1 tube $0.285 AB Availability likely +54%
ketoconazole 20 mg/g 00168-0099-15 E. 1 tube $0.285 AB Availability likely +54%
Ketoconazole 20 mg/g 16714-0955-01 NORTHSTAR 1 tube $0.285 AB Availability likely +54%
Ketoconazole 20 mg/g 21922-0025-04 Encube 1 tube $0.285 AB Availability likely +54%
Ketoconazole 20 mg/g 51672-1298-01 Sun 1 tube $0.285 AB Availability likely +54%
Ketoconazole 20 mg/g 50090-5265-00 A-S 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 50090-6046-00 A-S 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 50090-6069-00 A-S 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 51407-0279-15 Golden 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 63187-0774-15 Proficient 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 63629-8819-01 Bryant 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 63629-8820-01 Bryant 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 68071-1709-03 NuCare 30 g — AB FDA listed —
Ketoconazole 20 mg/g 68071-3512-05 NuCare 15 tubes — AB FDA listed —
Ketoconazole 20 mg/g 68788-8233-03 Preferred 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 70518-4236-00 REMEDYREPACK 1 tube — AB FDA listed —
Ketoconazole Cream 20 mg/g 72189-0422-30 Direct_Rx 30 g — AB FDA listed —
Ketoconazole 20 mg/g 82804-0091-15 Proficient 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 85766-0135-15 Sportpharm 1 tube — AB FDA listed —
Ketoconazole 20 mg/g 87063-0066-15 ASCLEMED 1 tube — 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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

LabelerIPG PHARMACEUTICALS, INC.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA075638 (ANDA)
Labeler code71085
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio12 products on file

More NDCs from IPG PHARMACEUTICALS, INC. labeler code 71085

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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 – Q4 2025 · 4 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
83
Units reimbursed last 4 qtrs
5K
Gross reimbursed last 4 qtrs
$1.7K
Avg / prescription
$20.86
Avg / unit
$0.3497
Latest quarter Q4 2025
32Rx
Medicaid pays / g
$0.3497
gross reimbursed
vs
NADAC / g
$0.1853
acquisition cost
=
Spread
+$0.1644
+89% 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 ⓘ
100% FFS
Fee-for-service · 83 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: 4,950 units · 25.3 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: no data reported 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: no data reported 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
25.325.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 25.3 /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.
← 71083-0020-05 · Theragnostics 71085-0073-60 · IPG →
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.