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Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream — NDC 13668-610-02 (Billing 13668-0610-02)
This is a package of Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream from Torrent Pharmaceuticals Limited, marketed since Jul 2020 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 13668-610-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 13668 labeler · 610 product · 02 package
- Package marketed since
- Jul 14, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0313668610017
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1053753
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 Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 13668-0610-01 13668-610-01 Main listing | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | 2020-07-14 | — | Active |
| 13668-0610-02 You're viewing this | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | 2020-07-14 | — | Active |
| 13668-0610-05 13668-610-05 | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | 2020-07-14 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream?
Therapeutic equivalents
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
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 6, 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 and Triamcinolone 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.
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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.
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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.
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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.
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UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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?
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 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 Torrent Pharmaceuticals Limited labeler code 13668
- Aprepitant 125 mg Capsule NDC 13668-593-86
- APREPITANT Kit NDC 13668-594-87
- Nystatin 100000 U/g Cream NDC 13668-595-01
- dapsone 75 mg/g Gel NDC 13668-605-05
- Erythromycin 250 mg Tablet, Coated NDC 13668-606-01
- Erythromycin 500 mg Tablet, Coated NDC 13668-607-01
- sacubitril and valsartan 24 mg; 26 mg Tablet NDC 13668-634-05
- sacubitril and valsartan 49 mg; 51 mg Tablet NDC 13668-635-05
- sacubitril and valsartan 97 mg; 103 mg Tablet NDC 13668-636-05
- Penciclovir 10 mg/g Cream NDC 13668-661-10
- Diclofenac Potassium 50 mg Powder, For Solution NDC 13668-672-64
- Dichlorphenamide 50 mg Tablet NDC 13668-676-01
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 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 ▾
DOSAGE AND ADMINISTRATION Nystatin and triamcinolone acetonide cream 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 should not be used with occlusive dressings.
⛔ Contraindications ▾
CONTRAINDICATIONS This preparation is contraindicated in those patients with a history of hypersensitivity to any of its components.
🤒 Adverse Reactions ▾
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 ▾
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 ▾
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 ▾
HOW SUPPLIED Nystatin and triamcinolone acetonide cream USP is supplied in: NDC 13668-610-01 15 g tube NDC 13668-610-02 30 g tube NDC 13668-610-05 60 g tube STORAGE: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Avoid Freezing. Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA .
Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920 8090494 October 2022 Image
📋 Description ▾
DESCRIPTION Nystatin and triamcinolone acetonide cream USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder.
Is hygroscopic and is affected by long exposure to light, heat and air. freely soluble in dimethylformamide and in dimethyl sulfoxide; very slightly soluble in methanol, practically insoluble or insoluble in water in alcohol, in n-propyl alcohol, in n-butyl alcohol, in chloroform and in ether. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.13 Triamcinolone acetonide USP is designated chemically as 9-fluoro-11ß, 16α, 17, 21-tetrahydroxy pregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone.
The white to cream crystalline powder having not more than a slight odour, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, in chloroform, and in methanol. Structural formula: Molecular formula : C 24 H 31 FO 6 Molecular weight : 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 in an aqueous cream base containing aluminium hydroxide gel, ceteareth-15, methylparaben, mono- and di- glycerides, polyoxyl 8 stearate, polysorbate 60, propylparaben, propylene glycol, simethicone emulsion, sorbic acid, noncrystallizing sorbitol solution, titanium dioxide and white petrolatum.
Image Image
⚠️ Precautions ▾
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 thermal 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. Information for the Patient: Patients using this medication should receive the following information and instructions: 1.
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occluded (see DOSAGE AND ADMINISTRATION ). 4. Patients should report any signs of local adverse reactions.
5. When using this medication in the inguinal area, patients should be advised to apply the cream sparingly and to wear loose fitting clothing. 6.
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. 7. 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: Teratogenic Effects: 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:… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 15 g tube label 15 g carton label 15g- tube 15 g carton
About this NDC listing & data coverage
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) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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. |