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TRIAMCINOLONE ACETONIDE 1 mg/g Cream, 15 g — NDC 61919-0650-15 package photo

TRIAMCINOLONE ACETONIDE 1 mg/g Cream, 15 g

by DIRECTRX · 15 g in 1 TUBE (61919-650-15)
NDC 61919-0650-15
🏷️ FDA NDC (as labeled) 61919-650-15 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

⚠️
Other active recalls for Triamcinolone Acetonide (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 · Sep 28, 2023 — Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. (Eugia US LLC) · FDA recall D-0041-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 61919-650-15
Product NDC 61919-650
11-digit billing NDC 61919065015
NCPDP billing unit GM — per gram (weight)
RxCUI 1014314, 1085636
UNII F446C597KA
Application # ANDA085692
SPL Set ID 835bbcd1-3869-646c-e053-2a91aa0a796a
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-03-05
Route TOPICAL
Dosage form CREAM
Substance TRIAMCINOLONE ACETONIDE
GPI-14 90550085103710
GPI class Triamcinolone Acetonide
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 61919-650-15 — 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 → 61919-0650-15. 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.

🏷️ 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.

🏭 Manufacturer & labeler

LabelerDIRECTRX
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA085692 (ANDA)
Labeler code61919
First marketedMar 2019
Product typeHuman Prescription Drug
Portfolio49 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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Triamcinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). It is also used as a dental paste to relieve the discomfort of mouth sores. Triamcinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, intra-articular triamcinolone is specifically approved to give short-term relief for knee arthritis, gout flares, bursitis, and similar joint conditions. The extended-release...
  • I'm getting a triamcinolone injection in my knee. Will it actually help, and how long does it last?
  • That's a really important thing to flag with your doctor before your injection or prescription. Triamcinolone can raise blood sugar — even in people whose diabetes is well-controll...
  • I have diabetes. Should I be worried about using triamcinolone?
📖 Read our full Triamcinolone guide →
8
Nutrient depletion considerations

Triamcinolone Acetonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Triamcinolone Acetonide nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • 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 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.

7 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.

💲 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 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 · Q2 2026 $0.1230 $1.85 / 15 g
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triamcinolone Acetonide 1 mg/g 45802-0064-05 Padagis 454 g $0.028 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 45802-0055-05 Padagis 454 g $0.035 AT Availability likely —
triamcinolone acetonide 1 mg/g 00168-0004-15 E. 1 tube $0.100 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 00713-0225-15 Cosette 1 tube $0.100 AT Discontinued —
Triamcinolone Acetonide 1 mg/g 16714-0986-01 NorthStar 1 tube $0.100 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 21922-0062-04 Encube 1 tube $0.100 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 33342-0329-15 Macleods 1 tube $0.100 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 51672-1282-01 Sun 1 tube $0.100 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 67877-0251-15 Ascend 15 g $0.100 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 71656-0042-15 Saptalis 1 tube $0.100 AT Availability likely —
Triamcinolone acetonide 1 mg/g 33342-0333-15 Macleods 1 tube $0.119 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 51672-1284-01 Sun 1 tube $0.119 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 00713-0228-15 Cosette 1 tube $0.119 AT Availability likely —
Triamcinolone acetonide 1 mg/g 16714-0276-01 NorthStar 1 tube $0.119 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 21922-0063-04 Encube 1 tube $0.119 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 00168-0006-15 E. 15 g $0.119 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 64980-0320-05 Rising 1 tube $2.686 AT Availability likely —
Triderm 1 mg/g 00316-0170-01 Crown 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 50090-0162-00 A-S 80 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 50090-0228-00 A-S 15 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 50090-2106-00 A-S 30000 mg — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 50090-6547-00 A-S 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 50090-6566-00 A-S 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 52817-0811-15 TruPharma, 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 61919-0234-30 Direct_Rx 30 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/gthis 61919-0650-15 DIRECTRX 15 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 63187-0025-15 Proficient 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 63187-0053-15 Proficient 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 63187-0870-15 Proficient 1 tube — — FDA listed —
Triamcinolone acetonide 1 mg/g 63629-8778-01 Bryant 15 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 63629-8779-01 Bryant 30 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 63629-8780-01 Bryant 80 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 63629-8781-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 63629-9573-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 63629-9574-01 Bryant 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 66267-0933-80 NuCare 80 g — — FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-2736-03 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-3666-03 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-3852-08 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-3982-05 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-4383-05 NuCare 15 g — — FDA listed —
triamcinolone acetonide 1 mg/g 68071-4391-03 NuCare 30 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-4945-05 NuCare 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68462-0131-17 Glenmark 1 tube — — FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-7797-01 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-8350-01 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-8356-00 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-8753-01 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-1524-00 REMEDYREPACK 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-2285-00 REMEDYREPACK 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-2403-00 REMEDYREPACK 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-2963-00 REMEDYREPACK 1 tube — AT Discontinued —
Triamcinolone Acetonide 1 mg/g 70518-4527-00 REMEDYREPACK 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 71205-0627-15 Proficient 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 71335-2211-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 71335-2712-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 71335-2713-01 Bryant 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72162-1386-04 Bryant 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 72162-1832-03 Bryant 30 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0039-80 Direct_Rx 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0277-15 Direct_Rx 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0330-80 Direct 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0571-80 Direct_rx 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0670-30 Direct_rx 30 g — AT FDA listed —
Dermavyx 72835-0777-02 V2 1 kit — — FDA listed —
Triamcinolone Acetonide 1 mg/g 76420-0203-15 Asclemed 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 76420-0348-00 Asclemed 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 82804-0071-30 Proficient 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 82804-0145-30 Proficient 1 tube — AT FDA listed —
Triadermex 84460-0100-08 Florrax 1 kit — — FDA listed —
Triamcinolone Acetonide 1 mg/g 50090-2244-00 A-S 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 50090-6978-00 A-S 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68462-0797-17 Glenmark 1 tube — — FDA listed —
Triamcinolone Acetonide 1 mg/g 71205-0108-15 Proficient 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-4286-05 NuCare 15 g — — FDA listed —
Triamcinolone Acetonide 1 mg/g 50090-3508-00 A-S 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-1872-08 NuCare 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-3689-00 REMEDYREPACK 1 tube — AT FDA listed —
Kourzeq 1 mg/g 82682-0001-05 MidAmerica 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 76420-0361-00 Asclemed 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 82804-0079-30 Proficient 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 50090-4761-00 A-S 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 50090-7679-00 A-S 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 61919-0619-15 DIRECTRX 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72162-2336-02 Bryant 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 67296-1927-01 RedpharmDrug 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 68071-2362-05 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-8386-05 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 85766-0244-15 Sportpharm 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 67296-2327-01 Redpharm 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

🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Triamcinolone Acetonide — 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 Triamcinolone Acetonide. 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
$17.79M
Claims incl. refills
1.7M
Beneficiaries
1.4M
Spend / beneficiary
$13.01
Spend / claim
$10.45
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Triamcinolone Acetonide — the ingredient across all brands.

Top reported reactions

Pruritus2,650
Rash2,534
Pain2,232
Fatigue2,133
Nausea2,043
Headache1,916
Condition Aggravated1,747

Reporter sex

31,697 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization6,577
Death3,076
Disabling2,415
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,201 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61919-0650-15 You're viewing this 15 g in 1 TUBE (61919-650-15) 2019-03-05 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ 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 price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 FDA registers it as 61919-650-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61919-0650-15, written without dashes as 61919065015. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61919-0650-15, the first segment (61919) is the labeler code FDA assigned to DIRECTRX; the middle segment (0650) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by DIRECTRX. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DIRECTRX 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.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 16 words ▾

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 70 words ▾

Apply to the affected area as a thin film as follows: Triamcinolone Acetonide Cream USP, 0.025% two to four times daily; Triamcinolone Acetonide Cream USP, 0.1% and 0.5% two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

⛔ Contraindications 20 words ▾

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 58 words ▾

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These 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, secondary infection, skin atrophy, striae and miliaria.

🆘 Overdosage 15 words ▾

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

🧬 Clinical Pharmacology 189 words ▾

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is 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. 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. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (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.

📦 How Supplied / Storage and Handling 81 words ▾

Triamcinolone Acetonide Cream USP, 0.025% Triamcinolone Acetonide Cream USP, 0.1% 15 gram tubes NDC 0168-0003-15 15 gram tubes NDC 0168-0004-15 80 gram tubes NDC 0168-0003-80 80 gram tubes NDC 0168-0004-80 1 Lb jars NDC 0168-0004-16 Triamcinolone Acetonide Cream USP, 0.5% 15 gram tubes NDC 0168-0002-15. Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat.

Protect from freezing. Fougera PHARMACEUTICALS INC. E.

FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville New York 11747 I20215G/IF20215G R09/11 #227 46165001A R06/15 #65

📋 Description 122 words ▾

Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. [chemstructure] Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.

Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61919-0645-28 · Direct_Rx 61919-0656-12 · DIRECT →
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.