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Nystatin 100000 [USP'U]/mL Suspension, 60 mL — NDC 00121-0868-02 package photo

Nystatin 100000 [USP'U]/mL Suspension, 60 mL

by PAI Holdings, LLC dba PAI Pharma · 60 mL in 1 BOTTLE, DROPPER (0121-0868-02)
NDC 00121-0868-02
🏷️ FDA NDC (as labeled) 0121-0868-02 billing pads the labeler segment with a zero
This package
Contains60 mL Cost per mL$0.1401 NADAC Per package$8.41 / 60 ml Pack sizes5 compare ↓
Also priced by: Medicaid pays $0.1605/unit · Part D plans $0.1064/unit — full pricing hub ↓
Also comes in: 10 cups 00121-0868-00 10 cups 00121-0868-40 10 cups 00121-0868-50 473 ml 00121-0868-16
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 6, 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 ↗
Past resolved recalls for this product (1)
Class II · Jul 29, 2021 · Terminated — Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. (PAI Holdings, LLC. dba Pharmaceutical Associates Inc) · FDA recall D-0721-2021

🆔 Identity & classification

FDA NDC (as labeled) 0121-0868-02
Product NDC 0121-0868
11-digit billing NDC 00121086802
NCPDP billing unit ML — per mL (volume)
RxCUI 312055
UNII BDF1O1C72E
UPC 0301210868160, 0301210868023
Application # ANDA203621
SPL Set ID 28b4e26e-206a-4e8a-abfe-774b780e91c3
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 2020-07-17
Route ORAL
Dosage form SUSPENSION
Substance NYSTATIN
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 0121-0868-02 — 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 → 00121-0868-02. 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

LabelerPAI Holdings, LLC dba PAI Pharma
Application holderPHARMACEUTICAL ASSOCIATES INC
FDA applicationANDA203621 (ANDA)
Labeler code00121
First marketedJul 2020
Product typeHuman Prescription Drug
Portfolio142 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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.140 $8.41 / 60 ml
Medicaid paysCMS SDUD · 12 mo $0.1605 $9.63 / 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 2021 Jul 2022 Dec 2025 Aug 2026 $0.162 $0.097
▲ Up 10% over the last 23 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 [USP'U]/mL 69315-0504-47 Leading 473 ml $0.058 AA Availability likely save 58%
Nystatin 100000 U/mL 85742-0013-11 Kanchan 473 ml $0.058 AA Availability likely save 58%
Nystatin 100000 [USP'U]/mLthis 00121-0868-02 PAI 60 ml $0.140 AA Availability likely —
Nystatin 100000 U/mL 62135-0813-46 Chartwell 60 ml $0.140 AA Availability likely —
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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 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 00121-0868-02, 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
28.7K
Units reimbursed last 4 qtrs
2.8M
Gross reimbursed last 4 qtrs
$448.7K
Avg / prescription
$15.61
Avg / unit
$0.1605
Latest quarter Q4 2025
11KRx
Medicaid pays / mL
$0.1605
gross reimbursed
vs
NADAC / mL
$0.1401
acquisition cost
=
Spread
+$0.0204
+15% 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 ⓘ
34% FFS 66% MCO
Fee-for-service · 9,626 Rx Managed care · 19,108 Rx
State Medicaid map
Alaska: 9,256 units · 1,263 per 100k residents AK Maine: 8,246 units · 591 per 100k residents ME Washington: 41,534 units · 532 per 100k residents WA Idaho: 5,108 units · 260 per 100k residents ID Montana: 8,110 units · 716 per 100k residents MT North Dakota: no data reported ND Minnesota: 26,774 units · 467 per 100k residents MN Wisconsin: 34,364 units · 581 per 100k residents WI Michigan: 75,003 units · 747 per 100k residents MI New York: 158,593 units · 810 per 100k residents NY Vermont: 1,560 units · 241 per 100k residents VT New Hampshire: 8,345 units · 595 per 100k residents NH Oregon: 17,671 units · 417 per 100k residents OR Nevada: 12,130 units · 380 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,119 units · 122 per 100k residents SD Iowa: 51,593 units · 1,609 per 100k residents IA Illinois: 86,571 units · 690 per 100k residents IL Indiana: 46,226 units · 674 per 100k residents IN Ohio: 71,458 units · 606 per 100k residents OH Pennsylvania: 88,317 units · 681 per 100k residents PA New Jersey: 34,728 units · 374 per 100k residents NJ Massachusetts: 83,661 units · 1,195 per 100k residents MA California: 344,049 units · 883 per 100k residents CA Utah: no data reported UT Colorado: 15,579 units · 265 per 100k residents CO Nebraska: 8,459 units · 428 per 100k residents NE Missouri: 45,039 units · 727 per 100k residents MO Kentucky: 52,812 units · 1,167 per 100k residents KY West Virginia: 14,365 units · 812 per 100k residents WV Virginia: 115,035 units · 1,320 per 100k residents VA Maryland: 71,776 units · 1,161 per 100k residents MD Connecticut: 52,463 units · 1,450 per 100k residents CT Rhode Island: 15,103 units · 1,379 per 100k residents RI Arizona: 32,102 units · 432 per 100k residents AZ New Mexico: 24,065 units · 1,138 per 100k residents NM Kansas: 8,064 units · 274 per 100k residents KS Arkansas: 17,349 units · 566 per 100k residents AR Tennessee: 115,712 units · 1,624 per 100k residents TN North Carolina: 191,546 units · 1,768 per 100k residents NC South Carolina: 63,965 units · 1,190 per 100k residents SC Delaware: 14,234 units · 1,381 per 100k residents DE Oklahoma: 30,920 units · 763 per 100k residents OK Louisiana: 60,423 units · 1,321 per 100k residents LA Mississippi: 30,564 units · 1,040 per 100k residents MS Alabama: 40,414 units · 791 per 100k residents AL Georgia: 94,463 units · 856 per 100k residents GA D.C.: 14,030 units · 2,066 per 100k residents DC Hawaii: 6,714 units · 468 per 100k residents HI Texas: 282,494 units · 926 per 100k residents TX Florida: 162,899 units · 720 per 100k residents FL
Units reimbursed · per 100k residents
1222,066
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 D.C. 2,066 /100k
2 North Carolina 1,768 /100k
3 Tennessee 1,624 /100k
4 Iowa 1,609 /100k
5 Connecticut 1,450 /100k
6 Delaware 1,381 /100k
7 Rhode Island 1,379 /100k
8 Louisiana 1,321 /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 ml00121-0868-16 141,810 Rx · $2,418,736
6 ml this page00121-0868-02 28,734 Rx · $448,675
10 cups00121-0868-00 1,089 Rx · $21,518
10 cups00121-0868-40 No Medicaid data
10 cups00121-0868-50 No Medicaid data
Drug total (last 4 qtrs): 171,633 Rx · 24,958,999 units · $2,888,928 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
00121-0868-00 10 TRAY in 1 CASE (0121-0868-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) $0.1755 / mL $87.75 2020-07-17 Active
00121-0868-02 You're viewing this 60 mL in 1 BOTTLE, DROPPER (0121-0868-02) $0.1401 / mL $8.41 2020-07-17 Active
00121-0868-16 473 mL in 1 BOTTLE (0121-0868-16) $0.0584 / mL $27.64 2020-07-17 Active
00121-0868-40 4 TRAY in 1 CASE (0121-0868-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) — — 2020-07-17 Discontinued by firm
00121-0868-50 5 TRAY in 1 CASE (0121-0868-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05) $0.2269 / mL $56.73 2020-07-17 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 17% 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 00121-0868-02?
NDC 00121-0868-02 contains 60 mL — 60 ml in 1 bottle, dropper.
What is the difference between NDC 00121-0868-02 and NDC 00121-0868-16?
Both are Nystatin 100000 [USP'U]/mL Suspension — the drug itself is identical. NDC 00121-0868-02 is the 60 mL package, while NDC 00121-0868-16 is the 473 ml package. Per-mL NADAC also differs: $0.1401 here vs $0.0584 for the 473 ml pack.
What NDC number is used to bill for this package of Nystatin 100000 [USP'U]/mL Suspension?
Bill NDC 00121-0868-02 — the 11-digit billing format is 00121086802. 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 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 112 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 to 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 77 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 PAI Pharma at 1-800-845-8210 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 130 words ▾

HOW SUPPLIED Nystatin Oral Suspension USP, 100,000 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms: NDC 0121-0868-02: 2 fl oz (60mL) bottle with calibrated dropper NDC 0121-0868-16: 16 fl oz (473mL) bottle NDC 0121-0868-05: 5mL unit dose cup. Case contains 40 unit dose cups of 5 mL (NDC 0121-0868-40) packaged in 4 trays of 10 unit dose cups each, 50 unit dose cups of 5 mL (NDC 0121-0868-50) packaged in 5 trays of 10 unit dose cups each and 100 unit dose cups of 5 mL (NDC 0121-0868-00) packaged in 10 trays of 10 unit dose cups each.

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 74 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 peppermint flavor, cherry flavor, citric acid, D&C Yellow No.

10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose. Nystatin structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00121-0865-00 · PAI 00121-0873-06 · PAI →
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.