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Ketoconazole 20 mg/g Cream — NDC 71085-008-45 (Billing 71085-0008-45)

by IPG PHARMACEUTICALS, INC. · 1 TUBE in 1 CARTON / 45 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.

NDC 71085-0008-45
🏷️ FDA NDC (as labeled) 71085-008-45 billing pads the product segment with a zero
This package
Contains45 g in 1 tube Pack sizes2 compare ↓
Product page 71085-0008-60 Also comes in: 60 g 71085-008-60
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71085-008-45
Product NDC 71085-008
11-digit billing NDC 71085000845
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
Why two NDCs? The FDA registers this code as 71085-008-45 — 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 → 71085-0008-45. 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

📗 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 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.
Try another pack size: 60 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
71085-0008-60 71085-008-60 Main listing 1 TUBE in 1 CARTON / 60 g in 1 TUBE $0.1853 / g $11.12 2016-12-21 — Active
71085-0008-45 You're viewing this 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 / 45 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/g 00093-3219-15 Teva 1 tube $0.285 AB Availability likely —
ketoconazole 20 mg/g 00168-0099-15 E. 1 tube $0.285 AB Availability likely —
Ketoconazole 20 mg/g 16714-0955-01 NORTHSTAR 1 tube $0.285 AB Availability likely —
Ketoconazole 20 mg/g 21922-0025-04 Encube 1 tube $0.285 AB Availability likely —
Ketoconazole 20 mg/g 51672-1298-01 Sun 1 tube $0.285 AB Availability likely —
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 —
Ketoconazole 20 mg/gthis 71085-0008-45 IPG 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
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 ↗

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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by IPG PHARMACEUTICALS, INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (71085-0008-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
IPG PHARMACEUTICALS, INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 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.