NDC 71656-0094-20 — Fluocinonide .5 mg/mL Solution, 20 mL

🆔 Identity & classification

FDA NDC (as labeled) 71656-094-20

Product NDC 71656-094

11-digit billing NDC 71656009420

NCPDP billing unit ML — per mL (volume)

RxCUI 310364

UNII 2W4A77YPAN

Application # ANDA207554

SPL Set ID 20f8e9a2-a63d-4bee-bc14-b9f04087d87b

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 2026-05-11

Route TOPICAL

Dosage form SOLUTION

Substance FLUOCINONIDE

GPI-14 90550060002005

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 71656-094-20 — 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 → 71656-0094-20. 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

LabelerSaptalis Pharmaceuticals, LLC.

Application holderSCIEGEN PHARMACEUTICALS INC

FDA applicationANDA207554 (ANDA)

Labeler code71656

First marketedMay 2026

Product typeHuman Prescription Drug

Portfolio11 products on file

🔎 All NDCs from Saptalis Pharmaceuticals, LLC.

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	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	$0.4094	$8.19 / 20 ml

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	—
Fluocinonide .5 mg/mL 21922-0001-01	Encube	1 bottle	$0.199	AT	Availability likely	—
Fluocinonide .5 mg/mL 70710-1284-03	Zydus	60 ml	$0.199	AT	Availability likely	—
Fluocinonide .5 mg/mL 70752-0154-05	QUAGEN	1 bottle	$0.199	AT	Availability likely	—
Fluocinonide .5 mg/mL 72603-0703-01	NorthStar	1 bottle	$0.199	AT	Availability likely	—
Fluocinonide .5 mg/mL 33342-0320-84	Macleods	1 bottle	$0.316	AT	Availability likely	—
Fluocinonide .5 mg/mL 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/mLthis 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

🏛️

2026

On the market since

May 2026

📍

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.

📊 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	Marketing start	Status
71656-0094-20 You're viewing this	20 mL in 1 BOTTLE (71656-094-20)	2026-05-11	Active
71656-0094-60	60 mL in 1 BOTTLE (71656-094-60)	2026-05-11	Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71656-0094-20?

NDC 71656-0094-20 contains 20 mL — 20 ml in 1 bottle.

What is the difference between NDC 71656-0094-20 and NDC 71656-0094-60?

Both are Fluocinonide .5 mg/mL Solution — the drug itself is identical. NDC 71656-0094-20 is the 20 mL package, while NDC 71656-0094-60 is the 60 ml package.

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

Bill NDC 71656-0094-20 — the 11-digit billing format is 71656009420. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 71656-094-20, 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: 71656-0094-20, written without dashes as 71656009420. 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 71656-0094-20, the first segment (71656) is the labeler code FDA assigned to Saptalis Pharmaceuticals, LLC.; the middle segment (0094) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) 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 Saptalis Pharmaceuticals, LLC.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 60 ml (71656-0094-60). 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?

Saptalis Pharmaceuticals, LLC. 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 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 61 words ▾

DOSAGE AND ADMINISTRATION Fluocinonide Topical Solution USP, 0.05% is generally applied to the affected area as a thinfilm 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 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

🆘 Overdosage 34 words ▾

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ). To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC. at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Clinical Pharmacology 60 words ▾

CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic 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 50 words ▾

HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is supplied in 20 mL (NDC 71656-094-20) and 60 mL (NDC 71656-094-60) bottles. Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F). Distributed by: Saptalis Pharmaceuticals, LLC. Hauppauge, NY 11788 MADE IN USA Revised: 01/2026-R1

📋 Description 88 words ▾

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only 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. fluocinonide01

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.

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.

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.

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

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

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 Saptalis labeler NDCsLabeler code 71656 📚 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.