![NYSTATIN 100000 [USP'U]/g Powder, 15 g — NDC 69315-0306-15 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=089e6444-2bd1-443e-acf0-dfeaa69faef9&name=Container-100000unit15gm.jpg)
NYSTATIN 100000 [USP'U]/g Powder, 15 g
by Leading Pharma, LLC · 15 g in 1 BOTTLE, PLASTIC (69315-306-15)
NDC 69315-0306-15
🏷️ FDA NDC (as labeled)
69315-306-15
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $0.6389/unit · Part D plans $0.3744/unit — full pricing hub ↓
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 →
⚠️
Other active recalls for Nystatin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 23, 2026 — Subpotent Drug: Low out of specification assay results performed during long-term stability testing. (Padagis US LLC) · FDA recall D-0677-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
69315-306-15
Product NDC
69315-306
11-digit billing NDC
69315030615
NCPDP billing unit
GM — per gram (weight)
RxCUI
646456
UNII
BDF1O1C72E
UPC
0369315306307, 0369315306604
Application #
ANDA208838
SPL Set ID
089e6444-2bd1-443e-acf0-dfeaa69faef9
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
2018-04-23
Route
TOPICAL
Dosage form
POWDER
Substance
NYSTATIN
GPI-14
90150080002920
GPI class
Nystatin
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
NYSTATIN 100,000 UNIT/GM POWD
FDB brand name
Nystatin
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 69315-306-15 — 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 → 69315-0306-15. 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
LabelerLeading Pharma, LLC
Application holderLYNE LABORATORIES INC
FDA applicationANDA208838 (ANDA)
Labeler code69315
First marketedApr 2018
Product typeHuman Prescription Drug
Portfolio83 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 NYSTATIN 100,000 UNIT/GM POWD 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nystatin — tap one for details:
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.
💬 Questions about NYSTATIN?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 | $0.421 | $6.32 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | $0.6389 | $9.58 / 15 g |
| Medicare drug plans payPart D · Q2 2026 | $0.3744 | $5.62 / 15 g |
NADAC price history (per g) — tap or hover for the price & month
▲ Up 17% 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 | $0.257 | AT | Availability likely | save 39% |
| Nystatin Topical Powder 100000 U/g 42806-0178-15 | Epic | 15 g | $0.307 | AT | FDA listed | save 27% |
| Nystatin 100000 [USP'U]/g 75907-0060-30 | Dr. | 30 g | $0.313 | AT | Availability likely | save 26% |
| Nyamyc 100000 [USP'U]/g 00832-0465-15 | Upsher-Smith | 1 bottle | $0.421 | AT | Availability likely | — |
| Klayesta 100000 U/g 42806-0186-15 | Epic | 15 g | $0.421 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 68382-0370-01 | Zydus | 15 g | $0.421 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/gthis 69315-0306-15 | Leading | 15 g | $0.421 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 72603-0491-01 | Northstar | 15 g | $0.421 | AT | Availability likely | — |
| 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
🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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 69315-0306-15, 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 – Q1 2026 · 5 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
18.9K
Units reimbursed last 4 qtrs
401.3K
Gross reimbursed last 4 qtrs
$256.4K
Avg / prescription
$13.55
Avg / unit
$0.6389
Latest quarter Q1 2026
4.2KRx
Medicaid pays / g
$0.6389
gross reimbursed
vs
NADAC / g
$0.4214
acquisition cost
=
Spread
+$0.2175
+52% 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 ⓘ
Fee-for-service · 6,351 Rx Managed care · 12,571 Rx
State Medicaid map
Units reimbursed · per 100k residents
10.3567
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Drug total (last 4 qtrs): 113,194 Rx · 5,560,080 units · $2,442,684 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 Nystatin — the program that covers self-administered drugs. 22 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 Nystatin. 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
$16.29M
Claims incl. refills
853.7K
Beneficiaries
614.3K
Spend / beneficiary
$26.52
Spend / claim
$19.08
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 Nystatin — the ingredient across all brands.
Top reported reactions
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 69315-0306-15 You're viewing this | 15 g in 1 BOTTLE, PLASTIC (69315-306-15) | $0.4214 / g | $6.32 | 2018-04-23 | Active |
| 69315-0306-30 | 30 g in 1 BOTTLE, PLASTIC (69315-306-30) | $0.3134 / g | $9.40 | 2018-04-23 | Active |
| 69315-0306-60 | 60 g in 1 BOTTLE, PLASTIC (69315-306-60) | $0.2574 / g | $15.44 | 2018-04-23 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Per g, this pack runs about 64% above the cheapest pack (60 g, $0.2574 vs $0.4214 NADAC).
This pack accounts for about 17% of this product's recent Medicaid fills; most go to the 60 g pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 69315-0306-15?
NDC 69315-0306-15 contains 15 g — 15 g in 1 bottle, plastic.
What is the difference between NDC 69315-0306-15 and NDC 69315-0306-30?
Both are NYSTATIN 100000 [USP'U]/g Powder — the drug itself is identical. NDC 69315-0306-15 is the 15 g package, while NDC 69315-0306-30 is the 30 g package. Per-g NADAC also differs: $0.4214 here vs $0.3134 for the 30 g pack.
What NDC number is used to bill for this package of NYSTATIN 100000 [USP'U]/g Powder?
Bill NDC 69315-0306-15 — the 11-digit billing format is 69315030615. 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
⛔ Contraindications
🧬 Clinical Pharmacology
📦 How Supplied / Storage and Handling
📋 Description
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species . Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.
⛔ Contraindications ▾
CONTRAINDICATIONS Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.
🧬 Clinical Pharmacology ▾
CLINCAL 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 ▾
HOW SUPPLIED Nystatin topical powder is supplied as 100,000 units nystatin per gram in plastic squeeze bottles: 15g (NDC 69315-306-15) 30g (NDC 69315-306-30) 60g (NDC 69315-306-60) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed. Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R1-01/20
📋 Description ▾
DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 nystatin units per gram dispersed in talc. Chemical-structure
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.