Nystatin 100000 [USP'U]/mL Suspension, 473 mL
by Taro Pharmaceuticals U.S.A., Inc. · 473 mL in 1 BOTTLE (51672-4117-9)
NDC 51672-4117-09
🏷️ FDA NDC (as labeled)
51672-4117-9
billing pads the package segment with a zero
This package
Contains473 mL
Pack sizes3 compare ↓
Also priced by: Part D plans $0.1064/unit — full pricing hub ↓
Rx only
Generic
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Jul 16, 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 ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Feb 1988. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
51672-4117-9
Product NDC
51672-4117
11-digit billing NDC
51672411709
NCPDP billing unit
ML — per mL (volume)
RxCUI
312055
UNII
BDF1O1C72E
Application #
ANDA062876
SPL Set ID
01c469b3-ec10-452c-8c02-3e7d22e40297
Established class (EPC)
Polyene Antifungal
Chemical class
Polyenes
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Feb 1988)
Marketing start
1988-02-29
Route
ORAL
Dosage form
SUSPENSION
Substance
NYSTATIN
GPI-14
88100010001805
GPI class
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
Why two NDCs?
The FDA registers this code as 51672-4117-9 — a 5-4-1 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 package segment → 51672-4117-09. 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
LabelerTaro Pharmaceuticals U.S.A., Inc.
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA062876 (ANDA)
Labeler code51672
First marketedFeb 1988
Product typeHuman Prescription Drug
Portfolio52 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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 | 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.
🔁 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 | 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 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]/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]/mLthis 51672-4117-09 | Taro | 473 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
🏛️
1988
On the market since
Feb 1988
📍
2026
Currently FDA-listed
38 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.
📊 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 | Marketing start | Status |
|---|---|---|---|
| 51672-4117-00 | 3785 mL in 1 BOTTLE (51672-4117-0) | 1988-02-29 | Discontinued by firm |
| 51672-4117-04 | 1 BOTTLE, DROPPER in 1 CARTON (51672-4117-4) / 60 mL in 1 BOTTLE, DROPPER | 1988-02-29 | Discontinued by firm |
| 51672-4117-09 You're viewing this | 473 mL in 1 BOTTLE (51672-4117-9) | 1988-02-29 | Discontinued by firm |
Pack size FAQ
What quantity is in NDC 51672-4117-09?
NDC 51672-4117-09 contains 473 mL — 473 ml in 1 bottle.
What is the difference between NDC 51672-4117-09 and NDC 51672-4117-00?
Both are Nystatin 100000 [USP'U]/mL Suspension — the drug itself is identical. NDC 51672-4117-09 is the 473 mL package, while NDC 51672-4117-00 is the 3785 ml package.
What NDC number is used to bill for this package of Nystatin 100000 [USP'U]/mL Suspension?
Bill NDC 51672-4117-09 — the 11-digit billing format is 51672411709. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Finished prescription product
No longer marketed (per FDA listing data)
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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 51672-4117-9, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51672-4117-09, written without dashes as 51672411709. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51672-4117-09, the first segment (51672) is the labeler code FDA assigned to Taro Pharmaceuticals U.S.A., Inc.; the middle segment (4117) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (51672-4117-04), 3785 ml (51672-4117-00). 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?
Taro Pharmaceuticals U.S.A., 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.
📄 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 ▾
INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
⏱️ Dosage and Administration ▾
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 ▾
CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
🤒 Adverse Reactions ▾
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.
🤰 Pregnancy ▾
Pregnancy
🧒 Pediatric Use ▾
Pediatric Use See DOSAGE AND ADMINISTRATION .
🆘 Overdosage ▾
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 ▾
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 ▾
HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin U/mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in: 2 fl oz (60 mL) bottles with 0.5 mL, 1 mL, 1.5 mL, 2 mL calibrated dropper NDC 51672-4117-4 1 Pint (473 mL) bottles NDC 51672-4117-9 1 Gallon (3785 mL) bottles (For repackaging only) NDC 51672-4117-0 SHAKE WELL BEFORE USING Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PHARMACIST: Dispense in a tight, light-resistant container as defined in USP.
📦 Storage and Handling ▾
Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PHARMACIST: Dispense in a tight, light-resistant container as defined in USP.
📋 Description ▾
DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension, for oral administration, is cherry/mint flavored, containing 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤1% v/v), benzaldehyde, edetate calcium disodium, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, sucrose (49.8% w/v), xanthan gum.
Chemical Structure
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.