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NYSTATIN 100000 [USP'U]/g Ointment — NDC 69315-307-15 (Billing 69315-0307-15)

by Leading Pharma, LLC · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of NYSTATIN 100000 [USP'U]/g Ointment from Leading Pharma, LLC, marketed since Aug 2019 and currently FDA-listed; retail pharmacies pay about $0.3345 per g (NADAC).

NDC 69315-0307-15
🏷️ FDA NDC (as labeled) 69315-307-15 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.3345 NADAC Per package$5.02 / 15 g Pack sizes2 compare ↓
Also priced by: Part D plans $0.4011/unit — full pricing hub ↓
Product page 69315-0307-30 Also comes in: 30 g 69315-307-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69315-307-15
Product NDC 69315-307
11-digit billing NDC 69315030715
NCPDP billing unit GM — per gram (weight)
RxCUI 884308
UNII BDF1O1C72E
Application # ANDA209082
SPL Set ID 8900ba02-2c6a-4dd4-b82f-45620c06e255
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 2019-08-19
Route TOPICAL
Dosage form OINTMENT
Substance NYSTATIN
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90150080004215
GPI class Nystatin
GCN Seq No 007283
GCN 30150
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 OINT
FDB brand name Nystatin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007283
  • GCN: 30150
  • GPI-14 (Medi-Span): 90150080004215
  • HICL (First Databank): 004129
  • AHFS class code: 08:14.28.00
  • RxCUI (RxNorm): 884308
Why two NDCs? The FDA registers this code as 69315-307-15 — 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 → 69315-0307-15. 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.

Clinical

Label name NYSTATIN 100,000 UNIT/GM OINT 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
  • It treats Candida yeast infections. Creams, ointment and powder are for the skin. The liquid is for the mouth. Tablets are for the digestive tract lining.
  • Place half the dose in each side of your mouth and keep it there as long as you can before swallowing. For babies, use the dropper and avoid feeding for 5 to 10 minutes. Keep going...
  • How do I use the liquid for a mouth infection?
  • Cream and ointment are usually applied twice a day. Powders are used two or three times a day. Keep using it until the area has healed, and follow your prescriber’s directions.
📖 Read our full Nystatin 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 $0.335 $5.02 / 15 g
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 $0.4011 $6.02 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jan 2022 Mar 2022 May 2022 $0.465 $0.329
▼ Down 11% over the last 6 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
69315-0307-15 You're viewing this 1 TUBE in 1 CARTON / 15 g in 1 TUBE $0.3345 / g $5.02 2019-08-19 — Active
69315-0307-30 69315-307-30 Main listing 1 TUBE in 1 CARTON / 30 g in 1 TUBE $0.2776 / g $8.33 2019-08-19 — Active

Per g, this pack runs about 20% above the cheapest pack (NDC 69315-0307-30, $0.2776 vs $0.3345 NADAC).

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of NYSTATIN 100000 [USP'U]/g Ointment?
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
Nystatin 100000 [USP'U]/g 45802-0059-11 Padagis 1 tube $0.151 AT Availability likely save 55%
Nystatin 100000 [USP'U]/g 51672-1289-01 Sun 1 tube $0.198 AT Availability likely save 41%
Nystatin 100000 [USP'U]/g 59651-0907-14 Aurobindo 1 tube $0.198 AT Availability likely save 41%
Nystatin 100000 [USP'U]/g 00472-0166-15 Actavis 1 tube $0.233 AT Availability likely save 30%
Nystatin 100000 [USP'U]/g 00713-0686-15 Cosette 1 tube $0.233 AT Availability likely save 30%
Nystatin 100000 U/g 13668-0534-01 Torrent 15 g $0.233 AT Availability likely save 30%
Nystatin 100000 1/g 33342-0481-15 Macleods 1 tube $0.233 AT Availability likely save 30%
Nystatin 100000 U/g 72578-0089-01 Viona 15 g $0.233 AT Availability likely save 30%
Nystatin 100000 [USP'U]/g 45802-0048-11 Padagis 1 tube $0.238 AT Availability likely save 29%
Nystatin 100000 [USP'U]/gthis 69315-0307-15 Leading 1 tube $0.334 AT FDA listed —
Nystatin 100000 U/g 50090-5845-00 A-S 15 g — AT FDA listed —
Nystatin 100000 [USP'U]/g 63187-0464-15 Proficient 1 tube — AT FDA listed —
Nystatin 100000 U/g 63629-2515-01 Bryant 30 g — AT FDA listed —
Nystatin 100000 U/g 63629-2516-01 Bryant 15 g — AT FDA listed —
Nystatin 100000 U/g 70771-1357-01 Zydus 15 g — AT FDA listed —
Nystatin 100000 [USP'U]/g 71205-0437-15 Proficient 1 tube — AT FDA listed —
Nystatin 100000 U/g 72162-2007-02 Bryant 15 g — AT FDA listed —
Nystatin 100000 [USP'U]/g 72162-2333-02 Bryant 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 63187-0703-15 Proficient 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 63187-0847-15 Proficient 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 50090-2854-00 A-S 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 72162-1385-02 Bryant 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 68071-4293-03 NuCare 30 g — AT FDA listed —
Nystatin 100000 [USP'U]/g 71335-2830-01 Bryant 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 72162-2496-02 Bryant 1 tube — AT FDA listed —
Mycostatin 100000 [USP'U]/g 72189-0408-15 Direct_Rx 15 g — AT FDA listed —
Nystatin 100000 [USP'U]/g 63629-8695-01 Bryant 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 50090-2763-00 A-S 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 63629-8694-01 Bryant 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 66267-0952-30 NuCare 30 g — AT FDA listed —
Nystatin 100000 [USP'U]/g 66267-0953-15 NuCare 15 g — AT FDA listed —
Nystatin 100000 [USP'U]/g 68071-2556-05 NuCare 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 50090-3772-00 A-S 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 50090-3799-00 A-S 1 tube — AT FDA listed —
Nystatin 100000 [USP'U]/g 68788-4099-01 Preferred 1 tube — 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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.

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

LabelerLeading Pharma, LLC
Application holderLYNE LABORATORIES INC
FDA applicationANDA209082 (ANDA)
Labeler code69315
First marketedAug 2019
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.

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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

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 Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.

⏱️ Dosage and Administration 26 words ▾

DOSAGE AND ADMINISTRATION Nystatin Ointment Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.

🤒 Adverse Reactions 65 words ▾

ADVERSE REACTIONS The frequency of adverse events reported in patients using Nystatin Ointment 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 ). CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.

🤰 Pregnancy 65 words ▾

Pregnancy: Teratogenic Effects Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations 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 ).

🧬 Clinical Pharmacology 156 words ▾

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 67 words ▾

HOW SUPPLIED Nystatin Ointment, USP (100,000 nystatin units per gram) is a yellow ointment available as follows: NDC 69315-307-15 15 gram tube NDC 69315-307-30 30 gram tube STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R0-12/17

📋 Description 51 words ▾

DESCRIPTION Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 Nystatin Ointment is for dermatologic use. Nystatin Ointment for topical use contains 100,000 USP nystatin units per gram in a polyethylene and mineral oil base. Chemical-structure

💬 Information for Patients ~1 min read ▾

INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are 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. Laboratory Tests If there is lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin.

No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility. Pregnancy: Teratogenic Effects Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation.

It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus. Nursing Mothers It is not known whether nystatin is excreted in human milk.

Caution should be exercised when nystatin is prescribed for a nursing woman. Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION ).

⚠️ Precautions 127 words ▾

PRECAUTIONS General Nystatin Ointment should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

General Nystatin Ointment should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

🍼 Nursing Mothers 25 words ▾

Nursing Mothers It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 38 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

📄 Package Label / Principal Display Panel 8 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton-100000unit15gm Container-100000unit15gm Carton-100000unit30gm Container-100000unit30gm

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 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.
← 69315-0306-15 · Leading 69315-0308-02 · Leading →
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.