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Nystatin 100000 U/mL Suspension, 60 mL — NDC 62135-0813-46 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nystatin 100000 U/mL Suspension, 60 mL — NDC 62135-813-46 (Billing 62135-0813-46)

by Chartwell RX, LLC · 60 mL in 1 BOTTLE

This is a package of 60 mL of Nystatin 100000 U/mL Suspension from Chartwell RX, LLC, marketed since Apr 1971 and currently FDA-listed; retail pharmacies pay about $0.1400 per mL (NADAC).

NDC 62135-0813-46
🏷️ FDA NDC (as labeled) 62135-813-46 billing pads the product segment with a zero
This package
Contains60 mL Cost per mL$0.1400 NADAC Per package$8.40 / 60 ml Pack sizes2 compare ↓
Also priced by: Part D plans $0.1064/unit — full pricing hub ↓
Product page 62135-0813-47 Also comes in: 473 ml 62135-813-47
Rx only Brand 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) 62135-813-46
Product NDC 62135-813
11-digit billing NDC 62135081346
NCPDP billing unit ML — per mL (volume)
RxCUI 312055
UNII BDF1O1C72E
UPC 0362135813475, 0362135813468
Application # NDA050299
SPL Set ID 9954118e-abe6-4388-98c9-4473d39b2e28
Established class (EPC) Polyene Antifungal
Chemical class Polyenes
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1971-04-14
Route ORAL
Dosage form SUSPENSION
Substance NYSTATIN
TE code (Orange Book) AA · RLD · RS

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

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
Quick answers
  • GSN (GCN sequence number): 009537
  • GCN: 42440
  • GPI-14 (Medi-Span): 88100010001805
  • HICL (First Databank): 004129
  • AHFS class code: 08:14.28.00
  • RxCUI (RxNorm): 312055
Why two NDCs? The FDA registers this code as 62135-813-46 — 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 → 62135-0813-46. 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/ML SUSP Ingredient Nystatin
📖 What it is MedlinePlus · NLM

Nystatin is used to treat fungal infections of the inside of the mouth and lining of the stomach and intestines. 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 mLPer package
Retail pharmacies payNADAC · weekly $0.140 $8.40 / 60 ml
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 $0.1064 $6.38 / 60 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.162 $0.140
▼ Down 13% over the last 10 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
62135-0813-46 You're viewing this 60 mL in 1 BOTTLE $0.1400 / mL $8.40 2024-06-27 — Active
62135-0813-47 62135-813-47 Main listing 473 mL in 1 BOTTLE $0.0569 / mL $26.93 2024-04-10 — Active

You're viewing the smallest of 2 pack sizes for this product.

Per mL, this pack runs about 146% above the cheapest pack (473 mL, $0.0569 vs $0.1400 NADAC).

This pack shows little to no recent Medicaid volume — the 473 ml pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 60 mL — 60 ml in 1 bottle.
How does this package differ from NDC 62135-0813-47?
Both are Nystatin 100000 U/mL Suspension — the drug itself is identical. This page's package is the 60 mL one, while NDC 62135-0813-47 is the 473 ml package. Per-mL NADAC also differs: $0.1400 here vs $0.0569 for the 473 ml pack.
What NDC number is used to bill for this package of Nystatin 100000 U/mL Suspension?
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]/mL 69315-0504-47 Leading 473 ml $0.057 AA Availability likely save 59%
Nystatin 100000 U/mL 85742-0013-11 Kanchan 473 ml $0.057 AA Availability likely save 59%
Nystatin 100000 [USP'U]/mL 00121-1045-16 PAI 473 ml $0.058 AA Discontinued save 58%
Nystatin 100000 U/mLthis 62135-0813-46 Chartwell 60 ml $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 an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
1971
On the market since
Apr 1971
📍
2026
Currently FDA-listed
55 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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 A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 25IH6R4SGF
    Edetate calcium disodium is a chelating agent, a chemical that binds to metal ions. It's used in some medications to prevent unwanted metals from interfering with the drug's stability and effectiveness.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 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 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.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderCHARTWELL MOLECULES LLC
FDA applicationNDA050299 (NDA AUTHORIZED GENERIC)
Labeler code62135
First marketedApr 1971
Product typeHuman Prescription Drug
Portfolio521 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 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 30 words ▾

ADVERSE REACTIONS 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 67 words ▾

HOW SUPPLIED Nystatin Oral Suspension, USP is a bright yellow color suspension with cherry flavor containing 100,000 units of nystatin per mL, supplied as follows: NDC 62135-813-46 – bottle of 60 mL with dropper NDC 62135-813-47 – bottle of 473 mL Store at controlled room temperature between 20°C to 25°C (68°F to 77°F). DO NOT FREEZE Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71884 Rev. 03/2026

📋 Description 113 words ▾

DESCRIPTION Nystatin, USP 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. Its structural formula is: C 47 H 75 NO 17 M.W .926 .13 Nystatin Oral Suspension, USP, is a cherry-flavored, ready-to-use suspension containing 100,000 units of Nystatin, USP per mL. Nystatin, USP contains the following inactive ingredients: artificial (wild) cherry flavor, D&C Yellow 10, edetate calcium disodium, hydrochloric acid, methylparaben, polysorbate 80, propylparaben, purified bentonite, purified water, sodium hydroxide and sucrose. image description

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Discontinue treatment with nystatin if sensitization or irritation is reported during use. Nystatin is not effective in the treatment of systemic mycoses since it is not significantly absorbed from the gastrointestinal tract. Information for the Patient Patient should be advised to retain nystatin in the mouth as long as possible and to continue its use for at least 2 days after symptoms have subsided.

There should be no interruption or discontinuation of the medication until the prescribed course of treatment is completed, even though symptomatic relief may occur within a few days. If symptoms of local irritation develop, the physician should be notified immediately. Laboratory Tests If there is a lack of therapeutic response, appropriate microbiological studies (e.g., KOH smears and/or cultures) should be repeated to confirm the diagnosis of candidiasis and rule out other pathogens before instituting another course of therapy.

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. In mice exposed to nystatin 50 mg/kg by injection, an increased incidence of chromosomal aberrations, consisting primarily of chromatid breaks, was observed in bone marrow cells. However, there have been no studies to determine the mutagenicity of orally-administered nystatin or its effects on fertility in males or females.

Pregnancy Teratogenic effects Teratogenicity studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed.

Nonteratogenic effects In one rat reproductive study, nystatin was administered orally to pregnant rats in single doses of 100, 500, or 3000 mg/kg on the ninth day of gestation, or as multiple doses of 500 mg/kg/day on gestation days 1-20, 1-4, 7-10, 11-14, or 15-18. It was found that nystatin had a slight abortive effect when used during the whole period of pregnancy. No abnormalities were seen in surviving fetuses.

Although no adverse effects or complications have been attributed to the use of intra-vaginal nystatin in neonates born to women treated during pregnancy, no similar studies evaluating complications of oral nystatin have been conducted. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Pediatric Use See DOSAGE AND ADMINISTRATION section for pediatric dosing recommendations.

📄 Package Label / Principal Display Panel 37 words ▾

PRINCIPAL DISPLAY PANEL Nystatin Oral Suspension, USP 100,000 units/mL - NDC 62135-813-46 - 60 ml Bottle Label Nystatin Oral Suspension, USP 100,000 units/mL - NDC 62135-813-47 - 1 Pint (473 mL) Bottle Label image description image description

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

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 ml62135-0813-47 1,018 Rx · $28,637
6 ml this page62135-0813-46 No Medicaid data
Drug total (last 4 qtrs): 1,018 Rx · 142,876 units · $28,637 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.
← 62135-0811-60 · Chartwell 62135-0814-45 · Chartwell →
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.