Nystatin 100000 U/g Ointment, 15 g — NDC 13668-534-01 (Billing 13668-0534-01)
This is a package of 15 g of Nystatin 100000 U/g Ointment from Torrent Pharmaceuticals Limited, marketed since Jan 2019 and currently FDA-listed; retail pharmacies pay about $0.2331 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 13668-534-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 13668 labeler · 534 product · 01 package
- Package marketed since
- Jan 29, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 15 g per package
- Barcode (UPC-A, from the NDC)
- 3 1366853401 6
- Medicaid fills, this package
- 3,305 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 | $0.233 | $3.50 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4681 | $7.02 / 15 g |
| Medicare drug plans payPart D · Q2 2026 | $0.4011 | $6.02 / 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 |
|---|---|---|---|---|---|---|
| 13668-0534-01 You're viewing this | 15 g in 1 TUBE | $0.2331 / g | $3.50 | 2019-01-29 | — | Active |
| 13668-0534-02 13668-534-02 Main listing | 30 g in 1 TUBE | $0.2375 / g | $7.13 | 2019-01-29 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.2331 NADAC).
This pack accounts for about 25% of this product's recent Medicaid fills; most go to the 30 g pack. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 13668-0534-02?
What NDC number is used to bill for this package of Nystatin 100000 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 U/g 13668-0595-01 | Torrent | 15 g | $0.198 | AT | Availability likely | save 15% |
| Nystatin 100000 [USP'U]/g 00472-0166-15 | Actavis | 1 tube | $0.233 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 00713-0686-15 | Cosette | 1 tube | $0.233 | AT | Availability likely | — |
| Nystatin 100000 U/gthis 13668-0534-01 | Torrent | 15 g | $0.233 | AT | Availability likely | — |
| Nystatin 100000 1/g 33342-0481-15 | Macleods | 1 tube | $0.233 | AT | Availability likely | — |
| Nystatin 100000 U/g 72578-0089-01 | Viona | 15 g | $0.233 | AT | Availability likely | — |
| Nystatin 100000 [USP'U]/g 45802-0048-11 | Padagis | 1 tube | $0.238 | AT | Availability likely | +2% |
| Nystatin 100000 [USP'U]/g 69315-0307-15 | Leading | 1 tube | $0.334 | AT | FDA listed | +44% |
| 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 U/g 82804-0045-15 | Proficient | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 68788-8631-01 | Preferred | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 72162-2576-02 | Bryant | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 50090-7303-00 | A-S | 15 g | — | AT | FDA listed | — |
| Nystatin 100000 U/g 67296-1519-01 | RedPharm | 15 g | — | 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 Torrent Pharmaceuticals Limited labeler code 13668
- Minocycline Hydrochloride 75 mg Tablet NDC 13668-486-01
- Minocycline Hydrochloride 100 mg Tablet NDC 13668-487-50
- Lurasidone hydrochloride 60 mg Tablet, Film Coated NDC 13668-509-30
- acyclovir 50 mg/g Ointment NDC 13668-515-01
- Mometasone Furoate 1 mg Ointment NDC 13668-527-01
- Montelukast Sodium 4 mg/500mg Granule NDC 13668-531-94
- Eslicarbazepine acetate 200 mg Tablet NDC 13668-538-05
- Eslicarbazepine acetate 400 mg Tablet NDC 13668-539-05
- Eslicarbazepine acetate 600 mg Tablet NDC 13668-540-05
- Eslicarbazepine acetate 800 mg Tablet NDC 13668-541-05
- Macitentan 10 mg Tablet NDC 13668-542-05
- Esomeprazole Magnesium for delayed-release oral suspension 2.5 mg Granule, Delayed Release NDC 13668-546-94
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 AND 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. )
🤰 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
🧬 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 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 USP, 100,000 units per gram is a pale yellow to yellow color ointment available as follows: NDC 13668-534-01 15 gram tube NDC 13668-534-02 30 gram tube STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Manufactured by: Torrent Pharmaceuticals LTD., Pithampur-454775, INDIA . Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920 8102492 Revised: March 2026 Image
📋 Description ▾
DESCRIPTION Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.09 g/mol Nystatin ointment is for dermatologic use. Nystatin ointment for topical use contains 100,000 USP nystatin units per gram in an ointment base of light mineral oil and white petrolatum. Image
💬 Information for Patients ▾
INFORMATION FOR 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. 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
⚠️ 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.
🍼 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 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 ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Ointment, USP 15 grams (Tube label) Nystatin Ointment, USP 15 grams (Carton label) Tube Label of 15 g Carton Label of 15 g