Nystatin and Triamcinolone Acetonide 100000; 1 [USP'U]/g; mg/g Cream, 15 g — NDC 0168-0081-15 (Billing 00168-0081-15)
by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. · 15 g in 1 TUBE
This is a package of 15 g of Nystatin and Triamcinolone Acetonide 100000; 1 [USP'U]/g; mg/g Cream from E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $0.4920 per g (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC 00168-0081-15
🏷️ FDA NDC (as labeled)
0168-0081-15
billing pads the labeler segment with a zero
This package
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 0168-0081-15 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0168 labeler · 0081 product · 15 package
- Billing quantity
- 15 g per package
- Barcode (UPC-A, from the NDC)
- 3 0168008115 1
- FDA record last changed
- Mar 13, 2024
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2020. 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)
0168-0081-15
Product NDC
0168-0081
11-digit billing NDC
00168008115
NCPDP billing unit
GM — per gram (weight)
Application #
ANDA062599
Chemical class
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Mar 2020)
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
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
- HICL (First Databank): 003161
- AHFS class code: 48:10.08.00
Why two NDCs?
The FDA registers this code as 0168-0081-15 — a 4-4-2 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 labeler segment → 00168-0081-15. 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.
- 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
Clinical
Label name NYSTATIN-TRIAMCINOLONE CREAM Ingredient Nystatin/Triamcinolone Acet
📗 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...
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about nystatin and triamcinolone acetonide?
Ask a pharmacist →
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 | $0.492 | $7.38 / 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
▼ Down 32% over the last 3 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.
- CMS NADAC weekly file · file of Mar 16, 2022
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 7, 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 |
|---|---|---|---|---|---|---|
| 00168-0081-15 You're viewing this Main listing | 15 g in 1 TUBE | $0.4920 / g | $7.38 | 1985-10-08 | — | Discontinued by firm |
| 00168-0081-30 0168-0081-30 | 30 g in 1 TUBE | $0.4762 / g | $14.28 | 1985-10-08 | — | Discontinued by firm |
| 00168-0081-60 0168-0081-60 | 60 g in 1 TUBE | $0.3188 / g | $19.13 | 1985-10-08 | — | Discontinued by firm |
You're viewing the smallest of 3 pack sizes for this product.
Per g, this pack runs about 54% above the cheapest pack (60 g, $0.3188 vs $0.4920 NADAC).
Pack size FAQ
What quantity is in this package?
This package contains 15 g — 15 g in 1 tube.
How does this package differ from NDC 00168-0081-30?
Both are Nystatin and Triamcinolone Acetonide 100000; 1 [USP'U]/g; mg/g Cream — the drug itself is identical. This page's package is the 15 g one, while NDC 00168-0081-30 is the 30 g package. Per-g NADAC also differs: $0.4920 here vs $0.4762 for the 30 g pack.
What NDC number is used to bill for this package of Nystatin and Triamcinolone Acetonide 100000; 1 [USP'U]/g; 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
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Mar 16, 2022
Availability & generic status
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA062599 (ANDA)
Labeler code00168
Product typeHuman Prescription Drug
Portfolio7 products on file
More NDCs from E. Fougera & Co. a division of Fougera Pharmaceu... labeler code 00168
- Betamethasone Dipropionate .5 mg/g Cream NDC 0168-0055-15
- Betamethasone Dipropionate .5 mg/g Ointment NDC 0168-0056-15
- Betamethasone Dipropionate .5 mg/mL Lotion NDC 0168-0057-60
- Fluocinolone Acetonide .1 mg/mL Solution NDC 0168-0059-60
- Fluocinolone Acetonide .25 mg/g Ointment NDC 0168-0064-15
- Hydrocortisone 25 mg/g Cream NDC 0168-0080-16
- ketoconazole 20 mg/g Cream NDC 0168-0099-15
- Swim-EAR 950 mg/mL Solution NDC 0168-0126-91
- Clotrimazole 10 mg/g Cream NDC 0168-0133-15
- fluocinonide .5 mg/mL Solution NDC 0168-0134-60
- Hydrocortisone 25 mg/g Ointment NDC 0168-0146-16
- Clobetasol Propionate .5 mg/g Ointment NDC 0168-0162-15
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
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 30 g (00168-0081-30), 60 g (00168-0081-60). 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?
E. Fougera & Co. a division of Fougera 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.