NDC 51672-1295-03 — Diflorasone Diacetate .5 mg/g Ointment

🆔 Identity & classification

FDA NDC (as labeled) 51672-1295-3

Product NDC 51672-1295

11-digit billing NDC 51672129503

NCPDP billing unit GM — per gram (weight)

RxCUI 966607

UNII 7W2J09SCWX

Application # ANDA075331

SPL Set ID b304dfca-e840-4c03-8217-73aaa5360277

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 1999-05-14

Route TOPICAL

Dosage form OINTMENT

Substance DIFLORASONE DIACETATE

GPI-14 90550050104205

GPI class Diflorasone Diacetate

GCN Seq No 007630

GCN 31480

HICL code 003325

Ingredient (HICL) Diflorasone Diacetate

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 DIFLORASONE 0.05% OINTMENT

FDB brand name Diflorasone Diacetate

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 51672-1295-3 — a 5-4-1 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 package segment → 51672-1295-03. 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, 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

LabelerSun Pharmaceutical Industries, Inc.

Application holderSUN PHARMA CANADA INC

FDA applicationANDA075331 (ANDA)

Labeler code51672

First marketedMay 1999

Product typeHuman Prescription Drug

Portfolio889 products on file

🔎 All NDCs from Sun Pharmaceutical Industries, 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 DIFLORASONE 0.05% OINTMENT Ingredient Diflorasone Diacetate

📗 Our plain-language guide HelloPharmacist

Diflorasone is used to calm inflamed, itchy skin conditions that respond to corticosteroid (steroid) treatment — a category doctors sometimes call corticosteroid-responsive dermato...
What skin conditions does diflorasone treat?
Apply a thin film of diflorasone diacetate ointment to the affected skin area, usually one to three times a day depending on how serious your condition is. 'Thin film' means just e...
An occlusive dressing is an airtight wrap or covering placed over the treated skin after applying the medication. It helps drive more of the ointment into the skin and can be usefu...

📖 Read our full Diflorasone Topical 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.

💊 What it looks like

Color white

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from 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.

3 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 g	Per package
Retail pharmacies payNADAC · weekly	$1.005	$60.30 / 60 g
Medicaid paysCMS SDUD · 12 mo	$1.49	$89.69 / 60 g
Medicare drug plans payPart D · Q2 2026	$7.86	$471.33 / 60 g

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

▼ Down 49% over the last 9 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
Diflorasone Diacetate .5 mg/gthis 51672-1295-03	Sun	1 tube	$1.005	AB	Availability likely	—
Diflorasone Diacetate .5 mg/g 64980-0124-03	Rising	1 tube	$3.250	AB	Availability likely	+223%
Diflorasone Diacetate .5 mg/g 51672-1296-01	Sun	1 tube	—	BX	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

🏛️

1999

On the market since

May 1999

📍

2026

Currently FDA-listed

27 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 51672-1295-03, 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

315

Units reimbursed last 4 qtrs

26.2K

Gross reimbursed last 4 qtrs

$39.1K

Avg / prescription

$124.14

Avg / unit

$1.4948

Latest quarter Q4 2025

76Rx

Medicaid pays / g

$1.4948

gross reimbursed

vs

NADAC / g

$1.0050

acquisition cost

=

Spread

+$0.4898

+49% vs cost

What Medicaid paid per g (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 ⓘ

77% FFS 23% MCO

Fee-for-service · 242 Rx Managed care · 73 Rx

State Medicaid map

Units reimbursed · per 100k residents

46.9104

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 New York 104 /100k

2 Illinois 46.9 /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 tube this page51672-1295-03 315 Rx · $39,104

1 tube51672-1295-02 18 Rx · $2,032

1 tube51672-1295-01 No Medicaid data

Drug total (last 4 qtrs): 333 Rx · 26,970 units · $41,136 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 Diflorasone Diacetate — the program that covers self-administered drugs. 2 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 Diflorasone Diacetate. 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

$3.45M

Claims incl. refills

6.1K

Beneficiaries

3.4K

Spend / beneficiary

$1,016.74

Spend / claim

$567.57

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
51672-1295-01	1 TUBE in 1 CARTON (51672-1295-1) / 15 g in 1 TUBE	—	—	1999-05-14	Active
51672-1295-02	1 TUBE in 1 CARTON (51672-1295-2) / 30 g in 1 TUBE	$3.25 / g	$97.50	1999-05-14	Active
51672-1295-03 You're viewing this	1 TUBE in 1 CARTON (51672-1295-3) / 60 g in 1 TUBE	$1.01 / g	$60.30	1999-05-14	Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($1.01 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 95% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-1295-03?

NDC 51672-1295-03 is listed by the FDA — 1 tube in 1 carton / 60 g in 1 tube.

What NDC number is used to bill for this package of Diflorasone Diacetate .5 mg/g Ointment?

Bill NDC 51672-1295-03 — the 11-digit billing format is 51672129503. 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 18 words ▾

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

⏱️ Dosage and Administration 63 words ▾

DOSAGE AND ADMINISTRATION Diflorasone diacetate ointment should be applied to the affected area as a thin film from one to three times daily depending on the severity or resistant nature 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 initiated.

⛔ Contraindications 21 words ▾

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

🤒 Adverse Reactions 58 words ▾

ADVERSE REACTIONS The following local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in 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 Miliaria

🤰 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 138 words ▾

Pediatric Use Safety and effectiveness of diflorasone diacetate ointment in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment.

Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in pediatric patients. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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.

🆘 Overdosage 17 words ▾

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

🧬 Clinical Pharmacology 192 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. 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. They 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.

🧬 Mechanism of Action 50 words ▾

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 37 words ▾

HOW SUPPLIED Diflorasone Diacetate Ointment USP, 0.05% is available in 15 gram (NDC 51672-1295-1), 30 gram (NDC 51672-1295-2) and 60 gram (NDC 51672-1295-3) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 13 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 66 words ▾

DESCRIPTION Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base. Chemically, diflorasone diacetate is 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below: molecular formula: C 26 H 32 F 2 O 7 molecular weight: 494.54 Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base of glyceryl monostearate, propylene glycol and white petrolatum.

Chemical Structure

💬 Information for Patients 124 words ▾

Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing.

Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on an infant or child being treated in the diaper area, as these garments may constitute occlusive dressings.

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.

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.

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

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.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

🔗 Related NDC lookups

🧪 All Diflorasone Diacetate NDCsSame ingredient 🏭 All Sun labeler NDCsLabeler code 51672 📚 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.