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NYSTATIN 100000 [USP'U]/mL Suspension — NDC 69315-0504-60 package photo

NYSTATIN 100000 [USP'U]/mL Suspension

by Leading Pharma, LLC · 1 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLE
NDC 69315-0504-60
🏷️ FDA NDC (as labeled) 69315-504-60 billing pads the product segment with a zero
This package
Contains60 mL in 1 bottle Cost per mL$0.1401 NADAC Per package$8.41 / 60 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1480/unit · Part D plans $0.1064/unit — full pricing hub ↓
Also comes in: 473 ml 69315-0504-47
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) 69315-504-60
Product NDC 69315-504
11-digit billing NDC 69315050460
NCPDP billing unit ML — per mL (volume)
RxCUI 312055
UNII BDF1O1C72E
UPC 0369315504475
Application # ANDA214346
SPL Set ID 954205d8-47ba-4c89-95cd-f0066a514cf9
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 2022-12-05
Route ORAL
Dosage form SUSPENSION
Substance NYSTATIN
GPI-14 88100010001805
GCN Seq No 009537
GCN 42440
HICL code 004129
Ingredient (HICL) Nystatin
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W3
Therapeutic class — intermediate (HIC2) Antimycotics
HIC3 code W3A
Therapeutic class — specific (HIC3) Antifungal Antibiotics
AHFS code 08:14.28.00
AHFS class Polyene Antifungals
FDB label name NYSTATIN 100,000 UNIT/ML SUSP
FDB brand name Nystatin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 69315-504-60 — 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 → 69315-0504-60. 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 holderSENORES PHARMACEUTICALS INC
FDA applicationANDA214346 (ANDA)
Labeler code69315
First marketedDec 2022
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/ML SUSP Ingredient Nystatin
📗 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 →
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.

💊 What it looks like

Color yellow
FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII SR60A3XG0F
    Cinnamal is a fragrant organic compound derived from cinnamon oil. It's used in medicines as a flavoring agent and fragrance to make the product taste or smell more pleasant.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

13 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 DailyMedingredient 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 mLPer package
Retail pharmacies payNADAC · weekly $0.140 $8.41 / 60 ml
Medicaid paysCMS SDUD · 12 mo $0.1480 $8.88 / 60 ml
Medicare drug plans payPart D · Q2 2026 $0.1064 $6.38 / 60 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Jan 2026 Apr 2026 Aug 2026 $0.162 $0.120
▼ Down 7% over the last 11 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nystatin 100000 [USP'U]/mL 00121-1045-16 PAI 473 ml $0.058 AA Discontinued save 58%
Nystatin 100000 U/mL 85742-0013-11 Kanchan 473 ml $0.058 AA Availability likely save 58%
Nystatin 100000 U/mL 62135-0813-46 Chartwell 60 ml $0.140 AA Availability likely
Nystatin 100000 [USP'U]/mLthis 69315-0504-60 Leading 1 bottle $0.140 AA Availability likely
Nystatin 100000 [USP'U]/mL 00121-0868-00 PAI 10 cups $0.176 AA FDA listed +25%
Nystatin 100000 [USP'U]/mL 00904-7276-70 Major 10 cups $0.176 AA FDA listed +25%
Nystatin 100000 [USP'U]/mL 60687-0800-17 American 10 cups $0.176 AA FDA listed +25%
Nystatin Oral Suspension 100000 [USP'U]/mL 00116-4026-11 Xttrium 10 cups AA FDA listed
Nystatin 100000 [USP'U]/mL 00121-0810-02 Pharmaceutical 60 ml AA FDA listed
Nystatin 100000 [USP'U]/mL 00121-4810-00 Pharmaceutical 10 cups AA FDA listed
Nystatin 100000 [USP'U]/mL 17856-0508-01 ATLANTIC 72 cups AA FDA listed
Nystatin 100000 [USP'U]/mL 17856-1045-01 ATLANTIC 72 cups AA Discontinued
Nystatin 100000 [USP'U]/mL 50090-1740-00 A-S 60 ml AA FDA listed
Nystatin 100000 [USP'U]/mL 50090-5315-00 A-S 60 ml AA FDA listed
Nystatin 100000 [USP'U]/mL 51672-4117-00 Taro 3785 ml Discontinued
Nystatin 100000 [USP'U]/mL 55154-4314-05 Cardinal 5 cups AA FDA listed
Nystatin 100000 [USP'U]/mL 55154-5788-05 Cardinal 5 cups AA FDA listed
Nystatin 100000 [USP'U]/mL 63629-8520-01 Bryant 473 ml AA FDA listed
Nystatin 100000 [USP'U]/mL 64950-0372-06 Genus 60 ml AA FDA listed
Nystatin 100000 [USP'U]/mL 68071-3543-06 NuCare 1 bottle AA FDA listed
Nystatin 100000 [USP'U]/mL 68788-8561-04 Preferred 473 ml AA FDA listed
Nystatin 100000 U/mL 68999-0813-24 Chartwell 10 cups AA FDA listed
Nystatin 100000 U/mL 72162-2645-02 Bryant 473 ml AA FDA listed
Nystatin 100000 U/mL 81033-0015-01 Kesin 100 cups AA 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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 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 69315-0504-60, 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
77.9K
Units reimbursed last 4 qtrs
8M
Gross reimbursed last 4 qtrs
$1.18M
Avg / prescription
$15.15
Avg / unit
$0.1480
Latest quarter Q4 2025
13.3KRx
Medicaid pays / mL
$0.1480
gross reimbursed
vs
NADAC / mL
$0.1401
acquisition cost
=
Spread
+$0.0079
+6% vs cost
What Medicaid paid per mL (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
31% FFS 69% MCO
Fee-for-service · 23,795 Rx Managed care · 54,134 Rx
State Medicaid map
Alaska: 2,680 units · 366 per 100k residents AK Maine: 32,172 units · 2,306 per 100k residents ME Washington: 98,292 units · 1,258 per 100k residents WA Idaho: 11,692 units · 595 per 100k residents ID Montana: 4,337 units · 383 per 100k residents MT North Dakota: 7,729 units · 987 per 100k residents ND Minnesota: 72,805 units · 1,269 per 100k residents MN Wisconsin: 39,497 units · 668 per 100k residents WI Michigan: 194,906 units · 1,942 per 100k residents MI New York: 540,892 units · 2,764 per 100k residents NY Vermont: 10,824 units · 1,673 per 100k residents VT New Hampshire: 21,856 units · 1,559 per 100k residents NH Oregon: 46,780 units · 1,105 per 100k residents OR Nevada: 107,801 units · 3,375 per 100k residents NV Wyoming: no data reported WY South Dakota: 822 units · 89.4 per 100k residents SD Iowa: 40,728 units · 1,270 per 100k residents IA Illinois: 151,464 units · 1,207 per 100k residents IL Indiana: 317,212 units · 4,623 per 100k residents IN Ohio: 411,950 units · 3,496 per 100k residents OH Pennsylvania: 487,639 units · 3,762 per 100k residents PA New Jersey: 147,103 units · 1,583 per 100k residents NJ Massachusetts: 346,243 units · 4,946 per 100k residents MA California: 899,582 units · 2,309 per 100k residents CA Utah: 12,038 units · 352 per 100k residents UT Colorado: 42,823 units · 729 per 100k residents CO Nebraska: 16,855 units · 852 per 100k residents NE Missouri: 102,053 units · 1,647 per 100k residents MO Kentucky: 135,457 units · 2,993 per 100k residents KY West Virginia: 95,085 units · 5,372 per 100k residents WV Virginia: 359,447 units · 4,124 per 100k residents VA Maryland: 224,254 units · 3,629 per 100k residents MD Connecticut: 172,833 units · 4,778 per 100k residents CT Rhode Island: 59,104 units · 5,398 per 100k residents RI Arizona: 148,284 units · 1,995 per 100k residents AZ New Mexico: 29,222 units · 1,382 per 100k residents NM Kansas: 20,589 units · 700 per 100k residents KS Arkansas: 39,747 units · 1,296 per 100k residents AR Tennessee: 117,270 units · 1,646 per 100k residents TN North Carolina: 352,553 units · 3,254 per 100k residents NC South Carolina: 208,654 units · 3,883 per 100k residents SC Delaware: 24,574 units · 2,384 per 100k residents DE Oklahoma: 70,127 units · 1,730 per 100k residents OK Louisiana: 96,114 units · 2,101 per 100k residents LA Mississippi: 59,129 units · 2,011 per 100k residents MS Alabama: 108,075 units · 2,116 per 100k residents AL Georgia: 314,654 units · 2,853 per 100k residents GA D.C.: 20,597 units · 3,033 per 100k residents DC Hawaii: 31,034 units · 2,163 per 100k residents HI Texas: 515,758 units · 1,691 per 100k residents TX Florida: 595,231 units · 2,633 per 100k residents FL
Units reimbursed · per 100k residents
89.45,398
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 Rhode Island 5,398 /100k
2 West Virginia 5,372 /100k
3 Massachusetts 4,946 /100k
4 Connecticut 4,778 /100k
5 Indiana 4,623 /100k
6 Virginia 4,124 /100k
7 South Carolina 3,883 /100k
8 Pennsylvania 3,762 /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.
473 ml69315-0504-47 179,426 Rx · $2,665,055
1 bottle this page69315-0504-60 77,929 Rx · $1,180,497
Drug total (last 4 qtrs): 257,355 Rx · 35,188,433 units · $3,845,552 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

Nausea2,063
Fatigue1,856
Diarrhoea1,844
Pneumonia1,689
Dyspnoea1,535
Vomiting1,409
Pain1,287

Reporter sex

0 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization12,179
Death3,747
Life-threatening1,753
Disabling743
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,483 0
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 Per unit Per pack Marketing startStatus
69315-0504-47 473 mL in 1 BOTTLE (69315-504-47) $0.0584 / mL $27.64 2022-12-05 Active
69315-0504-60 You're viewing this 1 BOTTLE in 1 PACKAGE (69315-504-60) / 60 mL in 1 BOTTLE $0.1401 / mL $8.41 2022-12-05 Active

Per mL, this pack runs about 140% above the cheapest pack (473 mL, $0.0584 vs $0.1401 NADAC).

This pack accounts for about 30% of this product's recent Medicaid fills; most go to the 473 ml pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 69315-0504-60?
NDC 69315-0504-60 is listed by the FDA — 1 bottle in 1 package / 60 ml in 1 bottle.
What NDC number is used to bill for this package of NYSTATIN 100000 [USP'U]/mL Suspension?
Bill NDC 69315-0504-60 — the 11-digit billing format is 69315050460. 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 21 words

INDICATIONS AND USAGE Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.

⏱️ Dosage and Administration 100 words

DOSAGE AND ADMINISTRATION Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth). Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective.

Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.

Contraindications 19 words

CONTRAINDICATIONS Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.

🤒 Adverse Reactions 47 words

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500 or www.fda.gov/medwatch. Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.

🆘 Overdosage 18 words

OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.

🧬 Clinical Pharmacology 46 words

CLINICAL PHARMACOLOGY Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.

📦 How Supplied / Storage and Handling 84 words

HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension, in the following sizes: 60 mL bottles with a child-resistant cap and calibrated dropper. 1 Pint (473 mL) bottles with a child-resistant cap. Storage This package is child-resistant.

Keep out of reach of children. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing NDC for 60 ml: 69315-504-60 NDC for 473 ml: 69315-504-47 Rx Only

📋 Description 113 words

DESCRIPTION Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B.

Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. Structural formula: Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), sucrose 50% w/v, peppermint oil, NF, cinnamaldehyde, disodium hydrogen phosphate, USP, carboxymethylcellulose sodium, USP, glycerin, USP, saccharin sodium, USP, cherry flavor, methylparaben, NF, propylparaben, NF and purified water, USP.

May also contain sodium hydroxide, NF and/ or hydrochloric acid, NF for pH adjustment. chemstructure

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.