NDC 43386-0026-02 — Fluocinonide .5 mg/mL Solution

🆔 Identity & classification

FDA NDC (as labeled) 43386-026-02

Product NDC 43386-026

11-digit billing NDC 43386002602

NCPDP billing unit ML — per mL (volume)

RxCUI 310364

UNII 2W4A77YPAN

Application # ANDA206003

SPL Set ID 43b7621c-6628-4b54-af32-32efd0f722da

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 2017-07-21

Route TOPICAL

Dosage form SOLUTION

Substance FLUOCINONIDE

GPI-14 90550060002005

GPI class Fluocinonide

GCN Seq No 007618

GCN 31401

HICL code 003318

Ingredient (HICL) Fluocinonide

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 84:06.08.00

AHFS class Corticosteroids (Skin, Mucous Membrane)

FDB label name FLUOCINONIDE 0.05% SOLUTION

FDB brand name Fluocinonide

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 43386-026-02 — 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 → 43386-0026-02. 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, Corticosteroids, potent (group III)

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

LabelerLupin Pharmaceuticals,Inc.

Application holderNOVEL LABORATORIES INC

FDA applicationANDA206003 (ANDA)

Labeler code43386

First marketedJul 2017

Product typeHuman Prescription Drug

Portfolio89 products on file

🔎 All NDCs from Lupin 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 FLUOCINONIDE 0.05% SOLUTION Ingredient Fluocinonide

📖 What it is MedlinePlus · NLM

Fluocinolone 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). Fluocinolone 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

Fluocinonide is used to calm inflamed, itchy skin — things like eczema (atopic dermatitis), psoriasis, and other inflammatory skin conditions that respond to steroid treatment. It...
What skin problems does fluocinonide actually treat?
Use a thin layer — just enough to cover the affected area — and rub it in gently. How often you apply it depends on your product and condition: some people use it once a day, other...
That's a really common feeling with skin conditions, but with the 0.1% strength products, treatment beyond 2 consecutive weeks is generally not recommended because of the risk of t...

📖 Read our full Fluocinonide guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
UNII P7E6YFV72X
Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
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 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.

5 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	$0.316	$6.33 / 20 ml
Medicaid paysCMS SDUD · 12 mo	$0.6624	$13.25 / 20 ml
Medicare drug plans payPart D · Q2 2026	$0.4094	$8.19 / 20 ml

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

▼ Down 51% 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
fluocinonide .5 mg/mL 00168-0134-60	E.	1 bottle	$0.199	AT	Availability likely	save 37%
Fluocinonide .5 mg/mL 21922-0001-01	Encube	1 bottle	$0.199	AT	Availability likely	save 37%
Fluocinonide .5 mg/mL 70710-1284-03	Zydus	60 ml	$0.199	AT	Availability likely	save 37%
Fluocinonide .5 mg/mL 70752-0154-05	QUAGEN	1 bottle	$0.199	AT	Availability likely	save 37%
Fluocinonide .5 mg/mL 72603-0703-01	NorthStar	1 bottle	$0.199	AT	Availability likely	save 37%
Fluocinonide .5 mg/mL 33342-0320-84	Macleods	1 bottle	$0.316	AT	Availability likely	—
Fluocinonide .5 mg/mLthis 43386-0026-02	Lupin	1 bottle	$0.316	AT	Availability likely	—
Fluocinonide .5 mg/mL 51672-1273-02	Sun	1 bottle	$0.316	AT	Availability likely	—
fluocinonide .5 mg/mL 40032-0026-06	Novel	1 bottle	—	AT	FDA listed	—
Fluocinonide .5 mg/mL 63629-9583-01	Bryant	1 bottle	—	AT	FDA listed	—
Fluocinonide .5 mg/mL 68071-3918-06	NuCare	1 bottle	—	AT	FDA listed	—
Fluocinonide .5 mg/mL 70771-1375-03	Zydus	60 ml	—	AT	FDA listed	—
Fluocinonide .5 mg/mL 71656-0094-20	Saptalis	20 ml	—	AT	FDA listed	—
Fluocinonide .5 mg/mL 72162-1270-06	Bryant	1 bottle	—	AT	FDA listed	—
fluocinonide .5 mg/mL 72162-2146-06	Bryant	1 bottle	—	AT	FDA listed	—
Fluocinonide .5 mg/mL 72162-2490-02	Bryant	1 bottle	—	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

🏛️

2017

On the market since

Jul 2017

📍

2026

Currently FDA-listed

9 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 43386-0026-02, 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

1.6K

Units reimbursed last 4 qtrs

49.8K

Gross reimbursed last 4 qtrs

$33K

Avg / prescription

$20.18

Avg / unit

$0.6624

Latest quarter Q4 2025

386Rx

Medicaid pays / mL

$0.6624

gross reimbursed

vs

NADAC / mL

$0.3163

acquisition cost

=

Spread

+$0.3461

+109% 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 ⓘ

34% FFS 66% MCO

Fee-for-service · 550 Rx Managed care · 1,084 Rx

State Medicaid map

Units reimbursed · per 100k residents

2.8115

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 Nevada 115 /100k

2 Arizona 73.7 /100k

3 Oregon 60.5 /100k

4 Kansas 36.7 /100k

5 New York 30.7 /100k

6 California 29.4 /100k

7 Colorado 29.3 /100k

8 Kentucky 28.3 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 bottle43386-0026-06 1,964 Rx · $45,981

1 bottle this page43386-0026-02 1,634 Rx · $32,973

Drug total (last 4 qtrs): 3,598 Rx · 170,580 units · $78,954 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Fluocinonide — the program that covers self-administered drugs. 13 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 Fluocinonide. 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

$6.96M

Claims incl. refills

176.2K

Beneficiaries

135.8K

Spend / beneficiary

$51.22

Spend / claim

$39.49

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
43386-0026-02 You're viewing this	1 BOTTLE in 1 CARTON (43386-026-02) / 20 mL in 1 BOTTLE	$0.3163 / mL	$6.33	2017-07-21	Active
43386-0026-06	1 BOTTLE in 1 CARTON (43386-026-06) / 60 mL in 1 BOTTLE	$0.1985 / mL	$11.91	2017-07-21	Active

Per mL, this pack runs about 59% above the cheapest pack (NDC 43386-0026-06, $0.1985 vs $0.3163 NADAC).

This pack accounts for about 45% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 43386-0026-02?

NDC 43386-0026-02 is listed by the FDA — 1 bottle in 1 carton / 20 ml in 1 bottle.

What NDC number is used to bill for this package of Fluocinonide .5 mg/mL Solution?

Bill NDC 43386-0026-02 — the 11-digit billing format is 43386002602. 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.

📄 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 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 22 words ▾

INDICATIONS AND USAGE Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 63 words ▾

DOSAGE AND ADMINISTRATION Fluocinonide Topical Solution USP, 0.05% is generally applied to the affected area as a thin film from two 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 the 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 59 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 Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria

🧒 Pediatric Use 114 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. Hypothalamic-pituitary-adrenal (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 210 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. 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. A significantly greater amount of fluocinonide is absorbed from the solution than from the cream or gel formulations.

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 72 words ▾

HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is supplied in 60ml HDPE Bottle - NDC 43386-026-06 and 20ml HDPE Bottle - NDC 43386-026-02. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F).

Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 or Lupin Limited Pithampur (M.P.) 454 775, INDIA November 2017 ID#: 253821

📋 Description 74 words ▾

DESCRIPTION Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water.

In this formulation, the active ingredient is totally in solution. Image

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.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

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.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

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

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

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

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 Fluocinonide NDCsSame ingredient 🏭 All Lupin labeler NDCsLabeler code 43386 📚 All Corticosteroid NDCsDrug class 📖 Read the Fluocinonide drug informationUses, warnings & side effects

💊 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.