Nystatin 100000 U/mL Suspension, 473 mL
by Chartwell RX, LLC · 473 mL in 1 BOTTLE (62135-813-47)
NDC 62135-0813-47
🏷️ FDA NDC (as labeled)
62135-813-47
billing pads the product segment with a zero
This package
Also priced by: Medicaid pays $0.2004/unit · Part D plans $0.1064/unit — full pricing hub ↓
Also comes in:
60 ml 62135-0813-46
Rx only
Brand
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)
62135-813-47
Product NDC
62135-813
11-digit billing NDC
62135081347
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
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 62135-813-47 — 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 → 62135-0813-47. 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
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.
🩺 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...
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.
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.
💲 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.058 | $27.62 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.2004 | $94.79 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1064 | $50.33 / 473 ml |
NADAC price history (per mL) — tap or hover for the price & month
▼ Down 7% over the last 9 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 |
|---|---|---|---|---|---|---|
| Nystatin 100000 [USP'U]/mL 00121-1045-16 | PAI | 473 ml | $0.058 | AA | Discontinued | — |
| Nystatin 100000 U/mLthis 62135-0813-47 | Chartwell | 473 ml | $0.058 | AA | Availability likely | — |
| Nystatin 100000 [USP'U]/mL 69315-0504-47 | Leading | 473 ml | $0.058 | AA | Availability likely | — |
| Nystatin 100000 U/mL 85742-0013-11 | Kanchan | 473 ml | $0.058 | AA | Availability likely | — |
| Nystatin 100000 [USP'U]/mL 00121-0868-00 | PAI | 10 cups | $0.176 | AA | FDA listed | +200% |
| Nystatin 100000 [USP'U]/mL 00904-7276-70 | Major | 10 cups | $0.176 | AA | FDA listed | +200% |
| Nystatin 100000 [USP'U]/mL 60687-0800-17 | American | 10 cups | $0.176 | AA | FDA listed | +200% |
| 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.
🗺️ 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 62135-0813-47, 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
1K
Units reimbursed last 4 qtrs
142.9K
Gross reimbursed last 4 qtrs
$28.6K
Avg / prescription
$28.13
Avg / unit
$0.2004
Latest quarter Q4 2025
379Rx
Medicaid pays / mL
$0.2004
gross reimbursed
vs
NADAC / mL
$0.0584
acquisition cost
=
Spread
+$0.1420
+243% 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 ⓘ
Fee-for-service · 263 Rx Managed care · 755 Rx
State Medicaid map
Units reimbursed · per 100k residents
9.9287
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): 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.
🔬 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 |
|---|---|---|---|---|---|
| 62135-0813-46 | 60 mL in 1 BOTTLE (62135-813-46) | $0.1401 / mL | $8.41 | 2024-06-27 | Active |
| 62135-0813-47 You're viewing this | 473 mL in 1 BOTTLE (62135-813-47) | $0.0584 / mL | $27.64 | 2024-04-10 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0584 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 62135-0813-47?
NDC 62135-0813-47 contains 473 mL — 473 ml in 1 bottle.
What is the difference between NDC 62135-0813-47 and NDC 62135-0813-46?
Both are Nystatin 100000 U/mL Suspension — the drug itself is identical. NDC 62135-0813-47 is the 473 mL package, while NDC 62135-0813-46 is the 60 ml package. Per-mL NADAC also differs: $0.0584 here vs $0.1401 for the 60 ml pack.
What NDC number is used to bill for this package of Nystatin 100000 U/mL Suspension?
Bill NDC 62135-0813-47 — the 11-digit billing format is 62135081347. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⛔ Contraindications
🤒 Adverse Reactions
🆘 Overdosage
🧬 Clinical Pharmacology
📦 How Supplied / Storage and Handling
📋 Description
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans .
⏱️ Dosage and Administration ▾
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 ▾
CONTRAINDICATIONS Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.
🤒 Adverse Reactions ▾
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 ▾
OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.
🧬 Clinical Pharmacology ▾
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 ▾
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 ▾
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
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.