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NYSTATIN 100000 [USP'U]/g Cream — NDC 59651-0907-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NYSTATIN 100000 [USP'U]/g Cream — NDC 59651-907-14 (Billing 59651-0907-14)

by Aurobindo Pharma Limited · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of NYSTATIN 100000 [USP'U]/g Cream from Aurobindo Pharma Limited, marketed since Mar 2025 and currently FDA-listed; retail pharmacies pay about $0.1983 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 59651-0907-14
🏷️ FDA NDC (as labeled) 59651-907-14 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.1983 NADAC Per package$2.97 / 15 g Pack sizes2 compare ↓
Also priced by: Part D plans $0.3523/unit — full pricing hub ↓
Main listing for product 59651-907 · Also comes in: 30 g 59651-907-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 59651-907-14 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59651 labeler · 907 product · 14 package
Package marketed since
Mar 21, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5965190714 6
FDA record last changed
Jul 24, 2026
⚠️
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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-907-14
Product NDC 59651-907
11-digit billing NDC 59651090714
NCPDP billing unit GM — per gram (weight)
RxCUI 543546
UNII BDF1O1C72E
Application # ANDA219527
SPL Set ID 7d8a30ab-465e-4804-a06b-afd689e16683
Established class (EPC) Polyene Antifungal
Chemical class Polyenes
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-21
Route TOPICAL
Dosage form CREAM
Substance NYSTATIN
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90150080003710
GCN Seq No 007282
GCN 30140
HICL code 004129
Ingredient (HICL) Nystatin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 08:14.28.00
AHFS class Polyene Antifungals
FDB label name NYSTATIN 100,000 UNIT/GM CREAM
FDB brand name Nystatin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • 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
Why two NDCs? The FDA registers this code as 59651-907-14 — a 5-3-2 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 product segment → 59651-0907-14. 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.

Clinical

Label name NYSTATIN 100,000 UNIT/GM CREAM Ingredient Nystatin
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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.
📖 Read our full Nystatin guide →
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.

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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.198 $2.97 / 15 g
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 $0.3523 $5.28 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Apr 2026 May 2026 Jul 2026 Sep 2026 $0.205 $0.195
▼ Down 3% over the last 6 months.
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
59651-0907-14 You're viewing this Main listing 1 TUBE in 1 CARTON / 15 g in 1 TUBE $0.1983 / g $2.97 2025-03-21 — Active
59651-0907-30 59651-907-30 1 TUBE in 1 CARTON / 30 g in 1 TUBE $0.1510 / g $4.53 2025-03-21 — Active

Per g, this pack runs about 31% above the cheapest pack (NDC 59651-0907-30, $0.1510 vs $0.1983 NADAC).

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of NYSTATIN 100000 [USP'U]/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nystatin 100000 [USP'U]/g 45802-0059-11 Padagis 1 tube $0.151 AT Availability likely save 24%
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]/g 51672-1289-01 Sun 1 tube $0.198 AT Availability likely —
Nystatin 100000 [USP'U]/gthis 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 —
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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 03J11K103C
    Algeldrate is an aluminum-based compound that neutralizes stomach acid. It's used in antacid formulations as the active therapeutic ingredient, though classified here as an excipient in combination products where it works alongside other components to relieve heartburn and indigestion.
  • UNII 867H4YOZ8Z
    A waxy compound made from plant or animal oils mixed with ethylene oxide. It helps oils and water blend together in creams and lotions, and makes the product easier to spread and absorb.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII KC98RO82HJ
    A waxy substance made from glycerin and fatty acids. It acts as an emulsifier to help mix oil and water components, and as a thickener to give the medicine proper texture and consistency.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 2P9L47VI5E
    A waxy compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and thickener, helping blend oil and water-based ingredients and giving the medicine a smooth, stable consistency.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

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.

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA219527 (ANDA)
Labeler code59651
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio1,456 products on file

More NDCs from Aurobindo Pharma Limited labeler code 59651

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.

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 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

INDICATIONS AND USAGE Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

⏱️ Dosage and Administration 24 words ▾

DOSAGE AND ADMINISTRATION Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.

🤒 Adverse Reactions 40 words ▾

ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin cream 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 59 words ▾

Pregnancy Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

🧒 Pediatric Use 22 words ▾

Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION .)

🧓 Geriatric Use 54 words ▾

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 155 words ▾

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 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 67 words ▾

HOW SUPPLIED Nystatin Cream USP is yellow to light green smooth cream and supplied as follows: Tube of 15 g NDC 59651-907-14 Tube of 30 g NDC 59651-907-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: May 2024

📋 Description 76 words ▾

DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Structural formula: C 47 H 75 NO 17 Molecular Weight: 926.13 Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, cream base containing aluminum hydroxide gel, ceteareth-15, mono and diglycerides, polyoxyl 8 stearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives. str

💬 Information for Patients 93 words ▾

INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: 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. 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.

If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Nystatin cream 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 PATIENT Patients using this medication should receive the following information and instructions: 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. 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.

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 the effects on male or female fertility. Pregnancy Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity.

Nystatin cream 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 25 words ▾

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 38 words ▾

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 the effects on male or female fertility.

📄 Package Label / Principal Display Panel 104 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO Keep this and all medications out of the reach of children. 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. AUROBINDO 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube59651-0907-30 65 Rx · $1,225
1 tube this page59651-0907-14 No Medicaid data
Drug total (last 4 qtrs): 65 Rx · 2,475 units · $1,225 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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.
← 59651-0906-01 · Aurobindo 59651-0908-90 · Aurobindo →
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.