Nystatin 100000 [USP'U]/g Ointment — NDC 45802-048-11 (Billing 45802-0048-11)
This is a package of Nystatin 100000 [USP'U]/g Ointment from Padagis Israel Pharmaceuticals Ltd, marketed since Sep 2006 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.
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 1, 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
- 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 1, 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 | $0.4813 | $14.44 / 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 |
|---|---|---|---|---|---|---|
| 45802-0048-11 You're viewing this Main listing | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.2375 / g | $7.13 | 2006-11-08 | — | Active |
| 45802-0048-35 45802-048-35 | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.2331 / g | $3.50 | 2006-09-15 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 60% 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 [USP'U]/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 [USP'U]/g 45802-0059-11 | Padagis | 1 tube | $0.151 | AT | Availability likely | save 36% |
| Nystatin 100000 [USP'U]/g 51672-1289-01 | Sun | 1 tube | $0.198 | AT | Availability likely | save 17% |
| Nystatin 100000 [USP'U]/g 59651-0907-14 | Aurobindo | 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 1/g 33342-0481-15 | Macleods | 1 tube | $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 [USP'U]/gthis 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 | — |
| 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 50090-2854-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-1385-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 68071-4293-03 | NuCare | 30 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 71335-2830-01 | Bryant | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 72162-2496-02 | Bryant | 1 tube | — | AT | FDA listed | — |
| Mycostatin 100000 [USP'U]/g 72189-0408-15 | Direct_Rx | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 63629-8695-01 | Bryant | 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 63629-8694-01 | 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 [USP'U]/g 68071-2556-05 | NuCare | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 50090-3772-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 50090-3799-00 | A-S | 1 tube | — | AT | FDA listed | — |
| Nystatin 100000 [USP'U]/g 68788-4099-01 | Preferred | 1 tube | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 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 Sep 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.
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 1, 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
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 USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia] albicans and other Candida species.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Nystatin Ointment USP should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder. This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.
⛔ Contraindications ▾
CONTRAINDICATIONS Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Nystatin Ointment USP is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei , and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida [Monilia] albicans and other Candida species.
It exhibits no appreciable activity against bacteria. Nystatin Ointment USP provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment.
Cure is effected both clinically and mycologically in most cases of localized candidiasis.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Nystatin Ointment USP (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows: 15 g tube (NDC 45802- 048 -35) 30 g tube (NDC 45802- 048 -11) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 01-23 7K600 RC PH1
📦 Storage and Handling ▾
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 01-23 7K600 RC PH1
📋 Description ▾
DESCRIPTION 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 structural formula
⚠️ Precautions ▾
PRECAUTIONS Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken. This preparation is not for ophthalmic use.
📄 Package Label / Principal Display Panel ▾
Principal Display Panel NDC 45802-048-35 Rx Only Nystatin Ointment 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. Nystatin Ointment USP carton serialization-template.jpg