NDC 00832-0465-30 — Nyamyc Nystatin 100000 [USP'U]/g Powder

🆔 Identity & classification

FDA NDC (as labeled) 0832-0465-30

Product NDC 0832-0465

11-digit billing NDC 00832046530

NCPDP billing unit GM — per gram (weight)

RxCUI 584414, 646456

UNII BDF1O1C72E

UPC 0308320465159

Application # ANDA065183

SPL Set ID 01b44f91-9b68-464a-9693-b5d3e793bf3c

Established class (EPC) Polyene Antifungal

Chemical class Polyenes

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2005-05-03

Route TOPICAL

Dosage form POWDER

Substance NYSTATIN

GPI-14 90150080002920

GPI class Nyamyc

GCN Seq No 007284

GCN 30160

HICL code 004129

Ingredient (HICL) Nystatin

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 08:14.28.00

AHFS class Polyene Antifungals

FDB label name NYAMYC 100,000 UNIT/GM POWDER

FDB brand name Nyamyc

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AT · RLD · RS

Why two NDCs? The FDA registers this code as 0832-0465-30 — a 4-4-2 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 labeler segment → 00832-0465-30. 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 Polyene Antifungal class.

Pharmacologic class Polyene Antifungal

Drug family (ATC) Antibiotics, Antibiotics, Antibiotics

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

LabelerUpsher-Smith Laboratories, LLC

Application holderUPSHER SMITH LABORATORIES LLC

FDA applicationANDA065183 (ANDA)

Labeler code00832

First marketedMay 2005

Product typeHuman Prescription Drug

Portfolio228 products on file

🔎 All NDCs from Upsher-Smith Laboratories, LLC

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 NYAMYC 100,000 UNIT/GM POWDER Ingredient Nystatin

📖 What it is MedlinePlus · NLM

Topical nystatin is used to treat fungal infections of the skin. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Nystatin treats yeast infections caused by Candida. Depending on the form you're given, it can clear up a yeast infection in your mouth (thrush), on your skin, or in your gastroint...
Shake it well, then swish it around your entire mouth — hold it there as long as you comfortably can before swallowing. If you're giving it to an infant, use the dropper to place h...
How do I use the oral suspension correctly?
Nystatin is generally very well tolerated. The most common complaints with the topical forms are minor — things like burning, itching, or redness right where you apply it. These ar...

📖 Read our full Nystatin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

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

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Nystatin (20 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 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

1 inactive ingredient 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 system	Per g	Per package
Retail pharmacies payNADAC · weekly	$0.312	$9.36 / 30 g
Medicaid paysCMS SDUD · 12 mo	$0.5072	$15.22 / 30 g
Medicare drug plans payPart D · Q2 2026	$0.3442	$10.33 / 30 g

NADAC price history (per g) — tap or hover for the price & month

Flat over the last 24 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Nystop 100000 [USP'U]/g 00574-2008-02	Padagis	60 g	$0.259	AT	Availability likely	save 17%
Nystatin Topical Powder 100000 U/g 42806-0178-15	Epic	15 g	$0.307	AT	FDA listed	save 2%
Nyamyc 100000 [USP'U]/gthis 00832-0465-30	Upsher-Smith	1 bottle	$0.312	AT	Availability likely	—
Nystatin 100000 [USP'U]/g 75907-0060-30	Dr.	30 g	$0.312	AT	Availability likely	—
Klayesta 100000 U/g 42806-0186-15	Epic	15 g	$0.437	AT	Availability likely	+40%
Nystatin 100000 [USP'U]/g 68382-0370-01	Zydus	15 g	$0.437	AT	Availability likely	+40%
Nystatin 100000 [USP'U]/g 69315-0306-15	Leading	15 g	$0.437	AT	Availability likely	+40%
Nystatin 100000 [USP'U]/g 72603-0491-01	Northstar	15 g	$0.437	AT	Availability likely	+40%
Nystatin Topical Powder 100000 U/g 42806-0185-15	Epic	15 g	—	AT	FDA listed	—
Nystop 100000 [USP'U]/g 63629-8696-01	Bryant	15 g	—	AT	FDA listed	—
Nystop 100000 [USP'U]/g 63629-8697-01	Bryant	30 g	—	AT	FDA listed	—
Nystop 100000 [USP'U]/g 63629-8698-01	Bryant	60 g	—	AT	FDA listed	—
Nystatin 100000 [USP'U]/g 70771-1585-01	Zydus	15 g	—	AT	FDA listed	—
Nystop 100000 [USP'U]/g 71335-2845-01	Bryant	15 g	—	AT	FDA listed	—
Nystop 100000 [USP'U]/g 71335-2869-01	Bryant	30 g	—	AT	FDA listed	—
Nystop 100000 [USP'U]/g 72162-1124-02	Bryant	15 g	—	AT	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

🏛️

2005

On the market since

May 2005

📍

2026

Currently FDA-listed

21 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.

🗺️ 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 00832-0465-30, 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

10.8K

Units reimbursed last 4 qtrs

402.8K

Gross reimbursed last 4 qtrs

$204.3K

Avg / prescription

$18.96

Avg / unit

$0.5072

Latest quarter Q4 2025

583Rx

Medicaid pays / g

$0.5072

gross reimbursed

vs

NADAC / g

$0.3119

acquisition cost

=

Spread

+$0.1953

+63% 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 ⓘ

51% FFS 49% MCO

Fee-for-service · 5,445 Rx Managed care · 5,330 Rx

State Medicaid map

Units reimbursed · per 100k residents

2.4549

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 West Virginia 549 /100k

2 South Dakota 369 /100k

3 Maine 357 /100k

4 Kentucky 353 /100k

5 New York 341 /100k

6 Pennsylvania 330 /100k

7 Iowa 296 /100k

8 Connecticut 269 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 bottle00832-0465-60 28,945 Rx · $716,211

1 bottle00832-0465-15 15,589 Rx · $231,320

1 bottle this page00832-0465-30 10,775 Rx · $204,278

Drug total (last 4 qtrs): 55,309 Rx · 2,517,424 units · $1,151,808 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Nyamyc — the program that covers self-administered drugs. 1 manufacturer.

⚠️ 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 Nyamyc. 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

$227.2K

Claims incl. refills

9.4K

Beneficiaries

6.8K

Spend / beneficiary

$33.63

Spend / claim

$24.30

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 NDC	Description	Per unit	Per pack	Marketing start	Status
00832-0465-15	1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15) / 15 g in 1 BOTTLE, PLASTIC	$0.4365 / g	$6.55	2005-05-03	Active
00832-0465-30 You're viewing this	1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30) / 30 g in 1 BOTTLE, PLASTIC	$0.3119 / g	$9.36	2005-05-03	Active
00832-0465-60	1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-60) / 60 g in 1 BOTTLE, PLASTIC	$0.2587 / g	$15.52	2012-03-09	Active

Per g, this pack runs about 21% above the cheapest pack (NDC 00832-0465-60, $0.2587 vs $0.3119 NADAC).

This pack accounts for about 19% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00832-0465-30?

NDC 00832-0465-30 is listed by the FDA — 1 bottle, plastic in 1 carton / 30 g in 1 bottle, plastic.

What NDC number is used to bill for this package of Nyamyc Nystatin 100000 [USP'U]/g Powder?

Bill NDC 00832-0465-30 — the 11-digit billing format is 00832046530. 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.

📄 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 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 43 words ▾

INDICATIONS AND USAGE Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use.

⏱️ Dosage and Administration 59 words ▾

DOSAGE AND ADMINISTRATION Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS Nyamyc® (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.

🤒 Adverse Reactions 40 words ▾

ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. [see PRECAUTIONS: General ].

🤰 Pregnancy 65 words ▾

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nyamyc® (Nystatin Topical Powder, USP) should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

🧒 Pediatric Use 22 words ▾

Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. [see DOSAGE AND ADMINISTRATION ].

🧓 Geriatric Use 55 words ▾

Geriatric Use Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 155 words ▾

CLINICAL PHARMACOLOGY Pharmacokinetics Nystatin is not absorbed from intact skin or mucous membrane. Microbiology Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.

On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well.

This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED Nyamyc® (Nystatin Topical Powder, USP) 100,000 units nystatin per gram is available as follow: Bottles of 15 g (NDC 0832-0465-15) Bottles of 30 g (NDC 0832-0465-30) Bottles of 60 g (NDC 0832-0465-60) STORAGE Nyamyc® (Nystatin Topical Powder, USP) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat (40°C/104°F). Keep tightly closed.

Keep out of reach of children. Nyamyc is a registered trademark of Upsher-Smith Laboratories, LLC.

📦 Storage and Handling 50 words ▾

STORAGE Nyamyc® (Nystatin Topical Powder, USP) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat (40°C/104°F). Keep tightly closed. Keep out of reach of children. Nyamyc is a registered trademark of Upsher-Smith Laboratories, LLC.

📋 Description 37 words ▾

DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Nyamyc® (Nystatin Topical Powder, USP) is for dermatologic use. Nyamyc® (Nystatin Topical Powder, USP) contains 100,000 USP nystatin units per gram dispersed in talc. Chemical Structure

💬 Information for Patients 93 words ▾

INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.

If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

fungal infection: An infection caused by a fungus, such as a yeast or mold, rather than by bacteria or a virus.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

mucocutaneous: Involving both the skin and the moist linings of the body, such as the mouth, eyes, or nose.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Nystatin NDCsSame ingredient 🏭 All Upsher-Smith labeler NDCsLabeler code 00832 📚 All Polyene Antifungal NDCsDrug class 📖 Read the Nystatin drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Antifungals.

Nystatin/Triamcinolone Acet 00168-0081-15 Miconazole Nitrate 00316-0225-15 Gentian Violet 00395-1003-92 Tolnaftate 00536-1315-43

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.