🆔 Identity & classification

FDA NDC (as labeled) 0713-0676-53

Product NDC 0713-0676

11-digit billing NDC 00713067653

NCPDP billing unit ML — per mL (volume)

RxCUI 1085745

UNII F446C597KA

UPC 0307130676533

Application # ANDA089129

SPL Set ID b93b6763-446b-3277-497b-2ee50dcef80c

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 2016-09-13

Route TOPICAL

Dosage form LOTION

Substance TRIAMCINOLONE ACETONIDE

GPI-14 90550085104110

GPI class Triamcinolone Acetonide

GCN Seq No 007600

GCN 31261

HICL code 002891

Ingredient (HICL) Triamcinolone Acetonide

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 Q5P

Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal

AHFS code 48:10.08.00

AHFS class Corticosteroids (Respiratory Tract)

FDB label name TRIAMCINOLONE 0.1% LOTION

FDB brand name Triamcinolone Acetonide

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AT · RLD · RS

Why two NDCs? The FDA registers this code as 0713-0676-53 — 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 → 00713-0676-53. 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

LabelerCosette Pharmaceuticals, Inc.

Application holderCOSETTE PHARMACEUTICALS NC LABORATORIES LLC

FDA applicationANDA089129 (ANDA)

Labeler code00713

First marketedSep 2016

Product typeHuman Prescription Drug

Portfolio99 products on file

🔎 All NDCs from Cosette Pharmaceuticals, Inc.

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

Label name TRIAMCINOLONE 0.1% LOTION Ingredient Triamcinolone Acetonide

📖 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Triamcinolone Acetonide — tap one for details:

St. John's WortMajor Bitter MelonModerate Black PepperModerate Bulbine NatalensisModerate CannabisModerate DanshenModerate Delta-9-tetrahydrocannabinol (thc)Moderate DiosminModerate

🌿 Every supplement checked against Triamcinolone Acetonide (104 interactions) — ranked by severity →

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.

ZINC Insignificant Depletion CALCIUM Moderate Depletion CHROMIUM Moderate Depletion MAGNESIUM Moderate Depletion POTASSIUM Moderate Depletion +3 more

🧪 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 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 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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 77K6Z421KU
Sorbitan monopalmitate is an emulsifier made from sorbitol, a natural sugar alcohol, combined with palmitic acid. It helps mix oil and water ingredients together in medications and keeps them evenly blended throughout the product's shelf life.
UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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.

8 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$0.277	$16.60 / 60 ml
Medicaid paysCMS SDUD · 12 mo	$0.3869	$23.21 / 60 ml
Medicare drug plans payPart D · Q2 2026	$0.3040	$18.24 / 60 ml

NADAC price history (per mL) — tap or hover for the price & month

▼ Down 16% over the last 24 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Triamcinolone Acetonide 1 mg/mLthis 00713-0676-53	Cosette	1 bottle	$0.277	AT	Availability likely	—
Triamcinolone Acetonide 1 mg/mL 42571-0385-19	MICRO	60 ml	$0.277	AT	Availability likely	—
Triamcinolone Acetonide 1 mg/mL 70752-0130-05	QUAGEN	60 ml	$0.277	AT	Availability likely	—
Triamcinolone Acetonide 1 mg/mL 71656-0040-60	Saptalis	60 ml	$0.277	AT	Availability likely	—
Triamcinolone Acetonide 1 mg/mL 72162-2070-06	Bryant	60 ml	—	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

🏛️

2016

On the market since

Sep 2016

📍

2026

Currently FDA-listed

10 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00713-0676-53, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

22K

Units reimbursed last 4 qtrs

1.4M

Gross reimbursed last 4 qtrs

$544.5K

Avg / prescription

$24.73

Avg / unit

$0.3869

Latest quarter Q4 2025

5KRx

Medicaid pays / mL

$0.3869

gross reimbursed

vs

NADAC / mL

$0.2767

acquisition cost

=

Spread

+$0.1102

+40% vs cost

What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

37% FFS 63% MCO

Fee-for-service · 8,106 Rx Managed care · 13,913 Rx

State Medicaid map

Units reimbursed · per 100k residents

7.71,302

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Alaska 1,302 /100k

2 Michigan 1,190 /100k

3 Rhode Island 1,162 /100k

4 New Mexico 1,064 /100k

5 Oregon 989 /100k

6 Kentucky 972 /100k

7 New York 935 /100k

8 Louisiana 921 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 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

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

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 NDC	Description	Marketing start	Status
00713-0676-53 You're viewing this	1 BOTTLE in 1 CARTON (0713-0676-53) / 60 mL in 1 BOTTLE	2016-09-13	Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 19 words ▾

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

⏱️ Dosage and Administration 59 words ▾

DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film from three to four 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 21 words ▾

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

🤒 Adverse Reactions 78 words ▾

ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 92 words ▾

Pregnancy Category C 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. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.

Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time.

🧒 Pediatric Use 113 words ▾

Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced 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.

🆘 Overdosage 17 words ▾

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

🧬 Clinical Pharmacology 60 words ▾

CLINICAL PHARMACOLOGY 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.

📦 How Supplied / Storage and Handling 49 words ▾

HOW SUPPLIED Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AVOID FREEZING. SHAKE WELL BEFORE USING Rx Only Distributed by: Cosette Pharmaceuticals, Inc, South Plainfield, NJ 07080 Iss. 02/2021 8-0676CPLNC1 VC7495

📋 Description 86 words ▾

DESCRIPTION Triamcinolone Acetonide Lotion, USP is supplied in the following strength: 0.1%. Each mL of Triamcinolone Acetonide Lotion, USP, 0.1%, contains 1 mg triamcinolone acetonide, USP in a lotion base containing citric acid, cetyl alcohol, simethicone emulsion 30%, polysorbate 20, propylene glycol, purified water, sorbitan monopalmitate, and stearyl alcohol. Triamcinolone Acetonide is a topical corticosteroid known chemically as 9-Fluoro-11β, 16 α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone.

The molecular formula is C 24 H 31 FO 6 . It has the following structure. Triamcinolone Acetonide Lotion-1

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

contact dermatitis: A skin rash caused by touching something that irritates the skin or triggers an allergy.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

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

🔗 Related NDC lookups

🧪 All Triamcinolone Acetonide NDCsSame ingredient 🏭 All Cosette labeler NDCsLabeler code 00713 📚 All Corticosteroid NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Anti-Inflammatory Steroidal.

Hydrocortisone 00096-0732-04 Hydrocortisone Acetate 24385-0190-03

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Triamcinolone Acetonide 1 mg/mL Lotion

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

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

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

📄 Full prescribing information FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class