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Nystatin 100000 [USP'U]/g Cream — NDC 45802-059-35 (Billing 45802-0059-35)
This is a package of Nystatin 100000 [USP'U]/g Cream from Padagis Israel Pharmaceuticals Ltd, marketed since Sep 2006 and currently FDA-listed; retail pharmacies pay about $0.1983 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 45802-059-35 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 45802 labeler · 059 product · 35 package
- Package marketed since
- Jan 25, 2007
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4580205935 2
- Medicaid fills, this package
- 47,427 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
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): 007282
- GCN: 30140
- GPI-14 (Medi-Span): 90150080003710
- HICL (First Databank): 004129
- AHFS class code: 08:14.28.00
- RxCUI (RxNorm): 543546
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 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 6, 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 | $0.198 | $2.97 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | $0.3551 | $5.33 / 15 g |
| Medicare drug plans payPart D · Q2 2026 | $0.3523 | $5.28 / 15 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 |
|---|---|---|---|---|---|---|
| 45802-0059-11 45802-059-11 Main listing | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.1510 / g | $4.53 | 2006-09-21 | — | Active |
| 45802-0059-35 You're viewing this | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.1983 / g | $2.97 | 2007-01-25 | — | Active |
Per g, this pack runs about 31% above the cheapest pack (NDC 45802-0059-11, $0.1510 vs $0.1983 NADAC).
This pack accounts for about 33% of this product's recent Medicaid fills; most go to a different pack size. 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 [USP'U]/g Cream?
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 [USP'U]/g 00713-0678-15 | Cosette | 1 tube | $0.198 | AT | Availability likely | — |
| Nystatin 100000 U/g 13668-0595-01 | Torrent | 15 g | $0.198 | AT | Availability likely | — |
| Nystatin 100000 1/g 33342-0469-15 | Macleods | 1 tube | $0.198 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/gthis 45802-0059-35 | Padagis | 1 tube | $0.198 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 51672-1289-01 | Sun | 1 tube | $0.198 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 59651-0907-14 | Aurobindo | 1 tube | $0.198 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 00472-0166-15 | Actavis | 1 tube | $0.233 | AT | Availability likely | +18% |
| Nystatin 100000 [USP'U]/g 45802-0048-11 | Padagis | 1 tube | $0.238 | AT | Availability likely | +20% |
| Nystatin 100000 [USP'U]/g 69315-0307-15 | Leading | 1 tube | $0.334 | AT | FDA listed | +69% |
| Nystatin Cream 100000 [USP'U]/g 00316-0221-15 | Crown | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 50090-2763-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 50090-2854-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 50090-3772-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 U/g 50090-7303-00 | A-S | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63187-0703-15 | Proficient | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63187-0847-15 | Proficient | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63629-8694-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63629-8695-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 66267-0952-30 | NuCare | 30 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 66267-0953-15 | NuCare | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 67296-1519-01 | RedPharm | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 68071-2556-05 | NuCare | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 68071-3911-05 | NuCare | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 68071-4293-03 | NuCare | 30 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 68788-4099-01 | Preferred | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 U/g 68788-8631-01 | Preferred | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 71205-0723-30 | Proficient | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 71335-2830-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-1385-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-2496-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 U/g 72162-2576-02 | Bryant | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72189-0278-15 | DIRECT | 15 g | — | AT | FDA listed | — |
| Mycostatin 100000 [USP'U]/g 72189-0408-15 | Direct_Rx | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 82804-0045-15 | Proficient | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63187-0464-15 | Proficient | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-2333-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 50090-3799-00 | A-S | 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
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 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 Padagis Israel Pharmaceuticals Ltd labeler code 45802
- Nystatin 100000 [USP'U]/g Ointment NDC 45802-048-11
- Triamcinolone Acetonide 5 mg/g Ointment NDC 45802-049-35
- Betamethasone Valerate 1.2 mg/g Aerosol, Foam NDC 45802-053-01
- Triamcinolone Acetonide .25 mg/g Ointment NDC 45802-054-05
- Triamcinolone Acetonide 1 mg/g Ointment NDC 45802-055-05
- Gentamicin Sulfate 1 mg/g Cream NDC 45802-056-11
- Bacitracin 500 [USP'U]/g Ointment NDC 45802-060-01
- Triamcinolone Acetonide .25 mg/g Cream NDC 45802-063-05
- Triamcinolone Acetonide 1 mg/g Cream NDC 45802-064-05
- Triamcinolone Acetonide 5 mg/g Cream NDC 45802-065-35
- Azelastine Hydrochloride and Fluticasone Propionate 137 ug; 50 ug Spray, Metered NDC 45802-066-01
- BRIMONIDINE 5 mg/g Gel NDC 45802-078-30
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 Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Very moist lesions are best treated with nystatin topical dusting powder. Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
⛔ Contraindications ▾
CONTRAINDICATIONS Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The frequency of adverse events reported in patients using Nystatin Cream USP 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 ).
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects: Category C - 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 ).
🧓 Geriatric Use ▾
Geriatric Use - Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics Nystatin Cream USP 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 levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of 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 Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: 15 g tube (NDC 45802- 059 -35) 30 g tube (NDC 45802- 059 -11) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula is C 47 H 75 NO 17 , and the molecular weight is 926.13. Structural formula: Nystatin Cream USP is for dermatologic use.
Nystatin Cream USP for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: emulsifying wax, glycerin, isopropyl myristate, lactic acid, purified water, sodium hydroxide, and sorbic acid. chemical structure
💬 Information for Patients ▾
Information for Patients - Patients using this medication should receive the following information and instructions: 1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is 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 Cream USP 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 Patients - Patients using this medication should receive the following information and instructions: 1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is 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. Carcinogenesis, Mutagenesis, 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: Category C - 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 ). Geriatric Use - Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🍼 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.
🧬 Pharmacokinetics ▾
Pharmacokinetics Nystatin Cream USP is not absorbed from intact skin or mucous membrane.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, 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 ▾
Principal Display Panel NDC 45802- 059 -11 Rx Only Nystatin Cream USP (100,000 USP Nystatin Units) NET WT 30 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. A white Nystatin Cream USP package with blue and black text serialization-template.jpg