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Econazole Nitrate 10 mg/g Cream — NDC 63629-8646-01 package photo

Econazole Nitrate 10 mg/g Cream

by Bryant Ranch Prepack · 1 TUBE in 1 CARTON (63629-8646-1) / 30 g in 1 TUBE
NDC 63629-8646-01
🏷️ FDA NDC (as labeled) 63629-8646-1 billing pads the package segment with a zero
Rx only Generic 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) 63629-8646-1
Product NDC 63629-8646
11-digit billing NDC 63629864601
NCPDP billing unit GM — per gram (weight)
RxCUI 857366
UNII H438WYN10E
Application # ANDA076479
SPL Set ID 4ac65707-a8b2-45de-a3c6-89e3ea845124
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-08-08
Route TOPICAL
Dosage form CREAM
Substance ECONAZOLE NITRATE
GPI-14 90154035103705
GPI class Econazole Nitrate
GCN Seq No 007371
GCN 30430
HICL code 016904
Ingredient (HICL) Econazole Nitrate
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 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name ECONAZOLE NITRATE 1% CREAM
FDB brand name Econazole Nitrate
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 63629-8646-1 — 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 → 63629-8646-01. 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 Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Imidazole and triazole derivatives, Imidazole derivatives
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

LabelerBryant Ranch Prepack
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA076479 (ANDA)
Labeler code63629
First marketedAug 2006
Product typeHuman Prescription Drug
Portfolio4,433 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

Label name ECONAZOLE NITRATE 1% CREAM Ingredient Econazole Nitrate
📖 What it is MedlinePlus · NLM

Econazole is used to treat skin infections such as athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Econazole is an antifungal cream or foam that you apply to your skin to clear up fungal infections. Depending on which form you have, it can treat athlete's foot (the kind between...
  • Many people notice some relief fairly soon after starting treatment. That said, it's really important to keep going for the full course your doctor recommends — even if your skin l...
  • How long does it take to work, and how long do I need to use it?
  • Econazole is generally very well tolerated. The most common side effects are mild — a little burning, itching, or redness right where you apply it. Those were reported in less than...
📖 Read our full Econazole Topical guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Econazole Nitrate — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Econazole Nitrate (3 interactions) — ranked by severity →
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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 0240V77G50
    A synthetic compound made by combining polyethylene glycol with oleic acid (a natural fatty acid). It acts as an emulsifier and solubilizer to help mix water and oil-based ingredients in the medicine.
  • UNII 3EW5AXE5X5
    A synthetic surfactant derived from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and improves how the medicine dissolves and is absorbed in the body.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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 · Q2 2026 $0.4803 $14.41 / 30 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Econazole Nitrate 10 mg/g 45802-0466-11 Padagis 1 tube $0.360 AB Availability likely —
Econazole Nitrate 10 mg/g 51672-1303-01 Sun 1 tube $0.399 AB Availability likely —
Econazole Nitrate 10 mg/g 59651-0945-14 Aurobindo 1 tube — AB FDA listed —
Econazole Nitrate 10 mg/g 63629-8645-01 Bryant 1 tube — AB FDA listed —
Econazole Nitrate 10 mg/gthis 63629-8646-01 Bryant 1 tube — AB FDA listed —
Econazole Nitrate 10 mg/g 63629-8647-01 Bryant 1 tube — AB FDA listed —
Econazole Nitrate 10 mg/g 68788-8170-03 Preferred 1 tube — AB FDA listed —
Econazole Nitrate 10 mg/g 68788-8174-01 Preferred 1 tube — AB FDA listed —
Econazole Nitrate 10 mg/g 68788-8884-03 Preferred 1 tube — AB FDA listed —
Econazole Nitrate 10 mg/g 72162-1410-04 Bryant 1 tube — AB FDA listed —
Econazole Nitrate 10 mg/g 21922-0111-04 Encube 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

🏛️
2006
On the market since
Aug 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.

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

Medicare Part D (outpatient prescription) spending for Econazole Nitrate — the program that covers self-administered drugs. 3 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 Econazole Nitrate. 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
$1.65M
Claims incl. refills
37.4K
Beneficiaries
29.7K
Spend / beneficiary
$55.48
Spend / claim
$44.08
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 Econazole Nitrate — the ingredient across all brands.

Top reported reactions

Fatigue60
Rash50
Dyspnoea47
Pain47
Nausea44
Diarrhoea42
Dizziness41

Age at onset

Adolescent1
Adult62
Elderly79

Reporter sex

919 reports
Male · 47%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization331
Death53
Disabling26
Life-threatening23
Reports over time (by year) — tap or hover for the count & year
2025 2026 54 33
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 NDCDescription Marketing startStatus
63629-8646-01 You're viewing this 1 TUBE in 1 CARTON (63629-8646-1) / 30 g in 1 TUBE 2006-11-10 Active

🧭 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 ✓ 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 ✓ 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 FDA registers it as 63629-8646-1, 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: 63629-8646-01, written without dashes as 63629864601. 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 63629-8646-01, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (8646) 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 Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.

📄 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 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 52 words ▾

INDICATIONS AND USAGE Econazole Nitrate Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

⏱️ Dosage and Administration 122 words ▾

DOSAGE AND ADMINISTRATION Sufficient Econazole Nitrate Cream, 1% should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Econazole Nitrate Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

⚠️ Warnings 9 words ▾

WARNINGS Econazole Nitrate Cream is not for ophthalmic use.

🤒 Adverse Reactions 43 words ▾

ADVERSE REACTIONS During clinical trials, approximately 3% of patients treated with econazole nitrate cream, 1% reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of pruritic rash has also been reported.

🔄 Drug Interactions 73 words ▾

Drug Interactions Warfarin Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.

🤰 Pregnancy 108 words ▾

Pregnancy Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose.

Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed.

🆘 Overdosage 36 words ▾

OVERDOSE Overdosage of econazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and >160 mg/kg, respectively.

🧬 Clinical Pharmacology 164 words ▾

CLINICAL PHARMACOLOGY After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes . Inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis.

Less than 1% of the applied dose was recovered in the urine and feces. Microbiology: Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Dermatophytes Yeasts Epidermophyton floccosum Trichophyton mentagrophytes Candida albicans Microsporum audouini Trichophyton rubrum Malassezia furfur Microsporum canis Trichophyton tonsurans Microsporum gypseum Econazole nitrate exhibits broad-spectrum antifungal activity against the following organisms in vitro , but the clinical significance of these data is unknown .

Dermatophytes Yeasts Trichophyton verrucosum Candida guillermondii Candida parapsilosis Candida tropicalis

📦 How Supplied / Storage and Handling 54 words ▾

HOW SUPPLIED Econazole Nitrate Cream, 1% is available as follows: 30 g tube (NDC 63629-8646-1) Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 53 words ▾

DESCRIPTION Econazole Nitrate Cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol-7 stearate, and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chlorophenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows:

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63629-8645-01 · Bryant 63629-8647-01 · Bryant →
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.