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Nystatin Oral Suspension 100000 [USP'U]/mL Suspension, 473 mL — NDC 00116-4026-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nystatin Oral Suspension 100000 [USP'U]/mL Suspension, 473 mL — NDC 0116-4026-16 (Billing 00116-4026-16)

by Xttrium Laboratories, Inc. · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Nystatin Oral Suspension 100000 [USP'U]/mL Suspension from Xttrium Laboratories, Inc., marketed since Feb 2026 and currently FDA-listed.

NDC 00116-4026-16
🏷️ FDA NDC (as labeled) 0116-4026-16 billing pads the labeler segment with a zero
This package
Contains473 mL Pack sizes3 compare ↓
Also priced by: Part D plans $0.1064/unit — full pricing hub ↓
Product page 00116-4026-11 Also comes in: 10 cups 0116-4026-11 10 cups 0116-4026-50
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

NDC database record

One package, one record: these facts belong to NDC 0116-4026-16 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0116 labeler · 4026 product · 16 package
Package marketed since
Feb 9, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0116402616 6
FDA record last changed
Jul 24, 2026
⚠️
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) 0116-4026-16
Product NDC 0116-4026
11-digit billing NDC 00116402616
RxCUI 312055
UNII BDF1O1C72E
Application # ANDA062512
SPL Set ID 4a670371-d373-1ba6-e063-6394a90a13b6
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 2026-02-06
Route ORAL
Dosage form SUSPENSION
Substance NYSTATIN
TE code (Orange Book) AA · RLD · RS
Quick answers
  • RxCUI (RxNorm): 312055
Why two NDCs? The FDA registers this code as 0116-4026-16 — a 4-4-2 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 labeler segment → 00116-4026-16. 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

📖 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 $50.33 / 473 ml
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 Marketing startMarketing endStatus
00116-4026-11 0116-4026-11 Main listing 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 2026-02-06 — Active
00116-4026-16 You're viewing this 473 mL in 1 BOTTLE, PLASTIC 2026-02-09 — Active
00116-4026-50 0116-4026-50 5 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 2026-02-09 — Active

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Nystatin Oral Suspension 100000 [USP'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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nystatin 100000 [USP'U]/mL 69315-0504-47 Leading 473 ml $0.057 AA Availability likely —
Nystatin 100000 U/mL 85742-0013-11 Kanchan 473 ml $0.057 AA Availability likely —
Nystatin 100000 [USP'U]/mL 00121-1045-16 PAI 473 ml $0.058 AA Discontinued —
Nystatin 100000 U/mL 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 —
Nystatin 100000 [USP'U]/mL 00904-7276-70 Major 10 cups $0.176 AA FDA listed —
Nystatin 100000 [USP'U]/mL 60687-0800-17 American 10 cups $0.176 AA FDA listed —
Nystatin Oral Suspension 100000 [USP'U]/mLthis 00116-4026-16 Xttrium 473 ml — 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

🧪 Avoiding an ingredient? See Nystatin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 4AJZ4765R9
    A flavoring agent derived from bananas that gives medicine a banana taste. It's added to make oral medications more palatable, especially for children.
  • UNII BUC5I9595W
    A natural flavoring derived from cherry fruit that gives the medicine its cherry taste. It helps mask bitter drug flavors and makes the medication more pleasant to take.
  • 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 CI71S98N1Z
    A mineral salt containing potassium and phosphate, used as a buffer to help maintain the medicine's pH level and stability during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 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.

14 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

LabelerXttrium Laboratories, Inc.
Application holderPHARMOBEDIENT CONSULTING LLC
FDA applicationANDA062512 (ANDA)
Labeler code00116
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio35 products on file

More NDCs from Xttrium Laboratories, Inc. labeler code 00116

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

⏱️ Dosage and Administration 110 words ▾

DOSAGE AND ADMINISTRATION INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS: 4-6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth).

The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans .

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

🤒 Adverse Reactions 78 words ▾

ADVERSE REACTIONS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General ).

Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 52 words ▾

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

🧒 Pediatric Use 7 words ▾

Pediatric Use See DOSAGE AND ADMINISTRATION .

🆘 Overdosage 34 words ▾

OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (See CLINICAL PHARMACOLOGY, Pharmacokinetics ).

🧬 Clinical Pharmacology 125 words ▾

CLINICAL PHARMACOLOGY Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo .

Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

📦 How Supplied / Storage and Handling 53 words ▾

HOW SUPPLIED Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available as a fruit flavored, light creamy yellow, ready-to-use suspension. 60 mL bottle was a calibrated dropper and 1 Pint (473 mL) bottles (0116-4026-16) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.

📦 Storage and Handling 16 words ▾

Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.

📋 Description 88 words ▾

DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: C 47 H 75 NO 17 MW 926.13 Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C Yellow #10, FD&C Red #40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%.

May also contain citric acid, USP for pH adjustment. nystatin chemical structure

⚠️ Precautions 152 words ▾

PRECAUTIONS General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential.

There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Nystatin oral suspension should be given to a pregnant woman only if clearly needed. 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 .

🍼 Nursing Mothers 33 words ▾

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.

🧬 Pharmacokinetics 37 words ▾

Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 35 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label NDC 0116-4026-16 NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL) Each mL contains: 100,000 units Nystatin, USP with the following inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C yellow #10, FD&C red #40, glycerin, USP, magnesium aluminum silicate, methyl paraben, NF, potassium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for Ph adjustment.

Fruit Flavored SHAKE WELL BEFORE USING Rx Only NET: 1 Pint (473 mL) USUAL DOSAGE: For infants: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). USUAL DOSAGE: For Children and Adults: See package insert. WARNINGS: Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AVOID FREEZING Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr.

Mount Prospect, IL 60056 402616BTLLBL REV. 09-25 16 oz bottle label

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label UNIT DOSE Delivers 5 mL NDC 0116-4026-05 NYSTATIN ORAL SUSPENSION, USP 500,000 units / 5 mL Alcohol ≤ 1% v/v SHAKE WELL Institutional Use Only Rx Only Xttrium Laboratories, Inc. Mount Prospect, IL SEE INSERT lid insert insert insert insert

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 (matched by generic name) — 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. CMS lists 4 products for this generic; we show the highest-spend one. 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 Oral Suspension (this brand).

Top reported reactions

Nausea1,982
Diarrhoea1,764
Fatigue1,761
Pneumonia1,631
Dyspnoea1,475
Vomiting1,371
Pain1,215

Age at onset

Neonate25
Infant58
Child157
Adolescent116
Adult2,243
Elderly1,762

Reporter sex

26,085 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization11,759
Life-threatening1,740
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,797 816
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Xttrium Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 cups (00116-4026-11), 10 cups (00116-4026-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Xttrium Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00116-4025-50 · Xttrium 00116-4027-10 · Xttrium →
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.