Nystatin 100000 1/g Ointment — NDC 33342-481-30 (Billing 33342-0481-30)
This is a package of Nystatin 100000 1/g Ointment from Macleods Pharmaceuticals Limited, marketed since Jan 2021 and currently FDA-listed; retail pharmacies pay about $0.2375 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 33342-481-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 33342 labeler · 481 product · 30 package
- Package marketed since
- Jan 29, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 3334248130 6
- Medicaid fills, this package
- 34,798 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Nystatin (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007283
- GCN: 30150
- GPI-14 (Medi-Span): 90150080004215
- HICL (First Databank): 004129
- AHFS class code: 08:14.28.00
- RxCUI (RxNorm): 884308
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Polyene Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Topical nystatin is used to treat fungal infections of the skin. 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 ↗- 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.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nystatin — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.238 | $7.13 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4019 | $12.06 / 30 g |
| Medicare drug plans payPart D · Q2 2026 | $0.4011 | $12.03 / 30 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 33342-0481-15 33342-481-15 | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.2331 / g | $3.50 | 2021-01-29 | — | Active |
| 33342-0481-30 You're viewing this Main listing | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.2375 / g | $7.13 | 2021-01-29 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 77% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Nystatin 100000 1/g Ointment?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nystatin 100000 1/g 33342-0469-15 | Macleods | 1 tube | $0.198 | AT | Availability likely | save 17% |
| Nystatin 100000 [USP'U]/g 00472-0166-15 | Actavis | 1 tube | $0.233 | AT | Availability likely | save 2% |
| Nystatin 100000 [USP'U]/g 00713-0686-15 | Cosette | 1 tube | $0.233 | AT | Availability likely | save 2% |
| Nystatin 100000 U/g 13668-0534-01 | Torrent | 15 g | $0.233 | AT | Availability likely | save 2% |
| Nystatin 100000 U/g 72578-0089-01 | Viona | 15 g | $0.233 | AT | Availability likely | save 2% |
| Nystatin 100000 1/gthis 33342-0481-30 | Macleods | 1 tube | $0.238 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 45802-0048-11 | Padagis | 1 tube | $0.238 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 69315-0307-15 | Leading | 1 tube | $0.334 | AT | FDA listed | +41% |
| Nystatin 100000 U/g 50090-5845-00 | A-S | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63187-0464-15 | Proficient | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 U/g 63629-2515-01 | Bryant | 30 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 63629-2516-01 | Bryant | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 70771-1357-01 | Zydus | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 71205-0437-15 | Proficient | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 U/g 72162-2007-02 | Bryant | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-2333-02 | Bryant | 1 tube | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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 N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
-
UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Macleods Pharmaceuticals Limited labeler code 33342
- Nebivolol 5 mg Tablet NDC 33342-458-07
- Nebivolol 10 mg Tablet NDC 33342-459-07
- Nebivolol 20 mg Tablet NDC 33342-460-07
- Pirfenidone Capsule, 267 mg 267 mg Capsule NDC 33342-461-38
- Triamterene and Hydrochlorothiazide 37.5 mg; 25 mg Capsule NDC 33342-467-11
- Nystatin 100000 1/g Cream NDC 33342-469-15
- Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g Cream NDC 33342-482-15
- Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g Ointment NDC 33342-483-15
- Rivaroxaban 2.5 mg Tablet, Film Coated NDC 33342-488-09
- Varenicline .5 mg Tablet, Film Coated NDC 33342-489-19
- Varenicline 1 mg Tablet, Film Coated NDC 33342-490-19
- Carbidopa, Levodopa and Entacapone 12.5 mg; 50 mg; 200 mg Tablet, Film Coated NDC 33342-491-11
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Nystatin Ointment, is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION Nystatin Ointment Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
⛔ Contraindications ▾
CONTRAINDICATIONS Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The frequency of adverse events reported in patients using Nystatin Ointment preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General.) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-338 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ).
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric use Safety and effectiveness have been established in the pediatric population from birth to 16 years. See DOSAGE AND ADMINISTRATION
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics Nystatin is not absorbed from intact skin or mucous membrane. Microbiology Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.
On repeated subculturing with increasing concentrations of nystatin, Candida albicans does not develop resistance to nystatin.Generally, resistance to nystatin does not develop during therapy. However, other species of 47 75 17 Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.
Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellowish ointment available as follows: NDC 33342-481-15 15 gram tube NDC 33342-481-30 30 gram tube Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev.
01/2021
📋 Description ▾
DESCRIPTION Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 structure.jpg
💬 Information for Patients ▾
INFORMATION FOR THE PATIENTS Patients using these medications should receive the following information and instructions : 1. The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.
2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. 3.
If symptoms of irritation develop, the patient should be advised to notify the physician promptly.
⚠️ Precautions ▾
PRECAUTIONS General Nystatin Ointment should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.
INFORMATION FOR THE PATIENTS Patients using these medications should receive the following information and instructions : 1. The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.
2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. 3.
If symptoms of irritation develop, the patient should be advised to notify the physician promptly. Laboratory Tests If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated. Carcinogenisis, Mutagenisis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin.
No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility. Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity.
Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus. Nursing Mothers It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
Pediatric use Safety and effectiveness have been established in the pediatric population from birth to 16 years. See DOSAGE AND ADMINISTRATION
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenisis, Mutagenisis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 15 g Tube NDC 33342-481-15 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 15 g Carton NDC 33342-481-15 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 30 g Tube NDC 33342-481-30 Nystatin Ointment (100,000 USP Nystatin Units per gram) Pack Count: 30 g Carton NDC 33342-481-30 nystatin-tube-15-gm nystatin-carton-15-gm nystatin-tube-30-gm nystatin-carton-30-gm