Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream — NDC 68180-0545-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream — NDC 68180-545-01 (Billing 68180-0545-01)

by Lupin Pharmaceuticals, Inc. · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream from Lupin Pharmaceuticals, Inc., no longer marketed (first marketed Nov 2018), no longer in the FDA NDC Directory; retail pharmacies pay about $0.4666 per g (NADAC).

NDC 68180-0545-01
🏷️ FDA NDC (as labeled) 68180-545-01 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.4666 NADAC Per package$7.00 / 15 g Pack sizes3 compare ↓
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68180-545-01
Product NDC 68180-545
11-digit billing NDC 68180054501
NCPDP billing unit GM — per gram (weight)
RxCUI 1053753
UNII BDF1O1C72E, F446C597KA
UPC 0368180545033
Application # ANDA208205
SPL Set ID 09140e74-c5ea-4c45-a5b1-e6f7f9ee1a23
Established class (EPC) Polyene Antifungal; Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
Chemical class Polyenes
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2018-11-29
Route TOPICAL
Dosage form CREAM
Substance NYSTATIN; TRIAMCINOLONE ACETONIDE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90159902253700
GPI class Nystatin-Triamcinolone
GCN Seq No 048529
GCN 14007
HICL code 003161
Ingredient (HICL) Nystatin/Triamcinolone Acet
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 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name NYSTATIN-TRIAMCINOLONE CREAM
FDB brand name Nystatin-Triamcinolone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048529
  • GCN: 14007
  • GPI-14 (Medi-Span): 90159902253700
  • HICL (First Databank): 003161
  • AHFS class code: 48:10.08.00
  • RxCUI (RxNorm): 1053753
Why two NDCs? The FDA registers this code as 68180-545-01 — 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 → 68180-0545-01. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
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-TRIAMCINOLONE CREAM Ingredient Nystatin/Triamcinolone Acet
📖 What it is MedlinePlus · NLM

The combination of nystatin and triamcinolone is used to treat fungal skin infections. It relieves itching, inflammation, and pain. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats cutaneous candidiasis, which is a yeast infection of the skin. The nystatin fights the yeast. The triamcinolone calms redness and itching, so you may feel relief faster t...
  • Usually you apply it to the affected skin twice a day, morning and evening. Massage the cream in gently, or spread the ointment as a thin film. Follow your prescriber's directions.
  • No. Do not use airtight (occlusive) dressings over it. They can greatly increase how much steroid your skin absorbs.
  • Most people have few problems. Some may notice burning, itching, dryness, irritation or acne-like bumps. Let your doctor know if skin thinning, stretch marks or lighter patches app...
📖 Read our full Nystatin and Triamcinolone 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 $0.467 $7.00 / 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 · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Feb 2022 Apr 2022 Jun 2022 $0.719 $0.380
▼ Down 35% over the last 7 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
68180-0545-01 You're viewing this 1 TUBE in 1 CARTON / 15 g in 1 TUBE $0.4666 / g $7.00 2018-11-29 — Discontinued by firm
68180-0545-02 68180-545-02 Main listing 1 TUBE in 1 CARTON / 30 g in 1 TUBE $0.2247 / g $6.74 2018-11-29 — Active
68180-0545-03 68180-545-03 1 TUBE in 1 CARTON / 60 g in 1 TUBE $0.1916 / g $11.49 2018-11-29 — Active

Per g, this pack runs about 144% above the cheapest pack (NDC 68180-0545-03, $0.1916 vs $0.4666 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

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 and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/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 and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68462-0799-17 Glenmark 1 tube $0.289 — FDA listed save 38%
Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 33342-0482-15 Macleods 1 tube $0.289 AT Availability likely save 38%
Nystatin And Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 45802-0880-14 Padagis 1 tube $0.289 AT Availability likely save 38%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 51672-1263-01 Sun 1 tube $0.289 AT Availability likely save 38%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 62332-0606-15 Alembic 1 tube $0.289 AT Availability likely save 38%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 51672-1272-01 Sun 1 tube $0.318 AT Availability likely save 32%
Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 33342-0483-15 Macleods 1 tube $0.345 AT Availability likely save 26%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 72578-0088-01 Viona 1 tube $0.345 AT Availability likely save 26%
nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 45802-0244-14 Padagis 1 tube $0.345 AT Availability likely save 26%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 62332-0585-15 Alembic 1 tube $0.345 AT Availability likely save 26%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 21922-0031-04 Encube 1 tube $0.345 AT Availability likely save 26%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/gthis 68180-0545-01 Lupin 1 tube $0.467 AT Discontinued —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68462-0314-17 Glenmark 1 tube $0.490 — FDA listed +5%
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 00316-0223-15 Crown 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 13668-0610-01 Torrent 1 tube — — FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 46708-0606-15 Alembic 1 tube — AT FDA listed —
Nystatin And Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-8688-01 Bryant 1 tube — AT FDA listed —
Nystatin And Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-8689-01 Bryant 1 tube — AT FDA listed —
Nystatin And Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-8690-01 Bryant 1 tube — AT FDA listed —
Nystatin And Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68071-2491-03 NuCare 1 tube — AT FDA listed —
Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 68071-3972-03 NuCare 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68071-5037-03 NuCare 30 g — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68788-8245-03 Preferred 1 tube — — FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68788-8553-03 Preferred 1 tube — AT Discontinued —
Nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 68788-8662-03 Preferred 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 68788-8808-03 Preferred 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 70518-1114-00 REMEDYREPACK 1 tube — AT FDA listed —
Nystatin And Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 71335-2894-01 Bryant 1 tube — AT FDA listed —
Nystatin And Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 72162-1433-02 Bryant 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-2497-01 Bryant 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 71335-2857-01 Bryant 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-2495-01 Bryant 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 71335-2847-01 Bryant 1 tube — AT FDA listed —
nystatin and triamcinolone acetonide 100000 [USP'U]/g; 1 mg/g 72162-1403-02 Bryant 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 70771-1447-01 Zydus 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 63629-2496-01 Bryant 1 tube — AT FDA listed —
Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g 72162-1275-02 Bryant 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 years 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.

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 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • 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 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.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • 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 CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • 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 X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

13 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

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN LTD
FDA applicationANDA208205 (ANDA)
Labeler code68180
First marketedNov 2018
Product typeHuman Prescription Drug
Portfolio404 products on file
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 40 words ▾

INDICATIONS AND USAGE Nystatin and Triamcinolone Acetonide Cream USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.

⏱️ Dosage and Administration 64 words ▾

DOSAGE AND ADMINISTRATION Nystatin and Triamcinolone Acetonide Cream USP is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS , Laboratory Tests). Nystatin and Triamcinolone Acetonide Cream USP should not be used with occlusive dressings.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.

🤒 Adverse Reactions 95 words ▾

ADVERSE REACTIONS A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur.

The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria.

🆘 Overdosage 31 words ▾

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS , General) ; however, acute overdosage and serious adverse effects with dermatologic use are unlikely.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Nystatin Nystatin exerts its antifungal activity against a variety of pathogenic and nonpathogenic yeasts and fungi by binding to sterols in the cell membrane. The binding process renders the cell membrane incapable of functioning as a selective barrier. Nystatin provides specific anticandidal activity to Candida (Monilia) albicans and other Candida species, but is not active against bacteria, protozoa, trichomonads, or viruses.

Nystatin is not absorbed from intact skin or mucous membranes. Triamcinolone Acetonide Triamcinolone acetonide is primarily effective because of its anti-inflammatory, antipruritic and vasoconstrictive actions, characteristic of the topical corticosteroid class of drugs. The pharmacologic effects of the topical corticosteroids are well known; however, the mechanisms of their dermatologic actions are unclear.

Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION ).

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.

Some of the topical corticosteroids and their metabolites are also excreted into the bile. Nystatin and Triamcinolone Acetonide During clinical studies of mild to severe manifestations of cutaneous candidiasis, patients treated with nystatin and triamcinolone acetonide showed a faster and more pronounced clearing of erythema and pruritus than patients treated with nystatin or triamcinolone acetonide alone.

📦 How Supplied / Storage and Handling 86 words ▾

HOW SUPPLIED Nystatin and Triamcinolone Acetonide Cream USP is supplied in 30 g, and 60 g tubes. NDC numbers are as follows: 30 g Tube 68180-545-02 60 g tube 68180-545-03 STORAGE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid Freezing.

LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 India November 2024 ID: 278152 Image

📋 Description 188 words ▾

DESCRIPTION Nystatin and Triamcinolone Acetonide Cream USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei . It is a yellow to light tan powder with a cereal like odor, practically insoluble in water, and practically insoluble in alcohol.

Structural formula: C 47 H 75 NO 17 MW = 926.23 Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16 α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream colored crystalline powder has a slight odor, is practically insoluble in water, and sparingly soluble in dehydrated alcohol. Structural formula: C 24 H 31 FO 6 MW = 434.50 Nystatin and Triamcinolone Acetonide Cream USP is a soft, smooth cream having a light yellow to buff color.

Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide USP in an aqueous perfumed vanishing cream base with cetearyl alcohol and ceteareth-20, dried aluminum hydroxide gel, methylparaben, mono- and di-glycerides, noncrystallizing sorbitol solution, polyoxyl (8) stearate, polysorbate 60, propylene glycol, propylparaben, simethicone emulsion, sorbic acid, titanium dioxide and white petrolatum. image image

💬 Information for Patients ~2 min read ▾

INFORMATION FOR PATIENTS Patients using this medication should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occluded (see DOSAGE AND ADMINISTRATION ). Patients should report any signs of local adverse reactions.

When using this medication in the inguinal area, patients should be advised to apply the cream sparingly and to wear loose fitting clothing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Patients should be advised on preventive measures to avoid reinfection.

Laboratory Tests If there is a lack of therapeutic response, appropriate microbiological studies (e.g KOH smears and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens, before instituting another course of therapy. A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression due to corticosteroids. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

Pregnancy Category C There are no teratogenic studies with combined nystatin and triamcinolone acetonide. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Therefore, any topical corticosteroid preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical preparations containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether any component of this preparation is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised during the use of this preparation by a nursing woman. Pediatric Use In clinical studies of a limited number of pediatric patients ranging from two months through 12 years, nystatin and triamcinolone acetonide cream formulation cleared or significantly ameliorated the disease state in most patients. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen.

Chronic corticosteroid therapy may interfere with the growth and development of children.

⚠️ Precautions 202 words ▾

PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions that augment systemic absorption include application of the more potent steroids; use over large surface areas, prolonged use, and the addition of occlusive dressings (see DOSAGE AND ADMINISTRATION ). Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of internal homeostasis.

If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, or substitute a less potent steroid. Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS , Pediatric Use). If irritation or hypersensitivity develops with the combination nystatin and triamcinolone acetonide, treatment should be discontinued and appropriate therapy instituted.

📄 Package Label / Principal Display Panel 71 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin and Triamcinolone Acetonide Cream USP 60 g Tube NDC 68180-545-03 Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. Nystatin and Triamcinolone Acetonide Cream USP 60 g Tube Carton NDC 68180-545-03 Rx only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. image image

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 tube68180-0545-02 3,888 Rx · $80,496
1 tube68180-0545-03 1,943 Rx · $54,698
Drug total (last 4 qtrs): 5,831 Rx · 254,162 units · $135,193 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (68180-0545-02), 1 tube (68180-0545-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Lupin Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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.