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Desoximetasone 2.5 mg/g Ointment, 15 g — NDC 68462-531-17 (Billing 68462-0531-17)

by Glenmark Pharmaceuticals Inc., USA · 15 g in 1 TUBE

This is a package of 15 g of Desoximetasone 2.5 mg/g Ointment from Glenmark Pharmaceuticals Inc., USA, marketed since Sep 2013 and currently FDA-listed; retail pharmacies pay about $0.6797 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 68462-0531-17
🏷️ FDA NDC (as labeled) 68462-531-17 billing pads the product segment with a zero
This package
Contains15 g Cost per g$0.6797 NADAC Per package$10.20 / 15 g Pack sizes2 compare ↓
Also priced by: Part D plans $0.7262/unit — full pricing hub ↓
Main listing for product 68462-531 · Also comes in: 60 g 68462-531-65
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 68462-531-17 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68462 labeler · 531 product · 17 package
Package marketed since
Sep 20, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
15 g per package
Barcode (UPC-A, from the NDC)
3 6846253117 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68462-531-17
Product NDC 68462-531
11-digit billing NDC 68462053117
NCPDP billing unit GM — per gram (weight)
RxCUI 197575
UNII 4E07GXB7AU
Application # ANDA202838
SPL Set ID ea742af6-9359-46c3-9164-ab53e8c1461e
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 2013-09-20
Route TOPICAL
Dosage form OINTMENT
Substance DESOXIMETASONE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90550040004205
GPI class Desoximetasone
GCN Seq No 007584
GCN 30800
HICL code 003309
Ingredient (HICL) Desoximetasone
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 DESOXIMETASONE 0.25% OINTMENT
FDB brand name Desoximetasone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007584
  • GCN: 30800
  • GPI-14 (Medi-Span): 90550040004205
  • HICL (First Databank): 003309
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 197575
Why two NDCs? The FDA registers this code as 68462-531-17 — 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 → 68462-0531-17. 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.

Clinical

Label name DESOXIMETASONE 0.25% OINTMENT Ingredient Desoximetasone
📖 What it is MedlinePlus · NLM

Desoximetasone topical is used to treat the redness, swelling, itching, 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). Desoximetasone 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
  • It depends on the product. Creams, gels and ointments calm inflamed, itchy skin from conditions that respond to steroids. The spray is used for plaque psoriasis in adults 18 and ol...
  • You put a thin film on the affected skin, usually twice a day, and rub it in gently. Don't cover the spray area with a bandage unless your doctor tells you to. Keep it away from yo...
  • Stop when your skin is under control. The label doesn't recommend using the spray beyond 4 weeks. Avoid your face, armpits and groin, and don't use it on skin that has thinned.
  • The most common are dryness, irritation and itching where you apply it. Call your doctor if you notice vision changes, thinning skin, stretch marks, or signs of infection.
📖 Read our full Desoximetasone guide →

Supplement & herbal interactions

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

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.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.680 $10.20 / 15 g
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 $0.7262 $10.89 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Mar 2022 Aug 2022 Nov 2023 $0.680 $0.443
▲ Up 17% over the last 6 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68462-0531-17 You're viewing this Main listing 15 g in 1 TUBE $0.6797 / g $10.20 2013-09-20 — Active
68462-0531-65 68462-531-65 60 g in 1 TUBE $0.3264 / g $19.58 2013-09-20 — Active

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

Per g, this pack runs about 108% above the cheapest pack (60 g, $0.3264 vs $0.6797 NADAC).

Pack size FAQ

What quantity is in this package?
This package contains 15 g — 15 g in 1 tube.
How does this package differ from NDC 68462-0531-65?
Both are Desoximetasone 2.5 mg/g Ointment — the drug itself is identical. This page's package is the 15 g one, while NDC 68462-0531-65 is the 60 g package. Per-g NADAC also differs: $0.6797 here vs $0.3264 for the 60 g pack.
What NDC number is used to bill for this package of Desoximetasone 2.5 mg/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Desoximetasone 2.5 mg/g 00472-0479-15 Actavis 1 tube $0.369 AB Availability likely save 46%
desoximetasone 2.5 mg/g 45802-0496-14 Padagis 1 tube $0.369 AB Availability likely save 46%
Desoximetasone 2.5 mg/g 68180-0946-01 Lupin 1 tube $0.369 AB Availability likely save 46%
desoximetasone 2.5 mg/g 72578-0095-01 Viona 1 tube $0.369 AB Availability likely save 46%
Desoximetasone 2.5 mg/g 00472-0478-15 Actavis 1 tube $0.394 AB Discontinued save 42%
desoximetasone 2.5 mg/g 72578-0091-01 Viona 1 tube $0.398 AB Availability likely save 41%
Desoximetasone 2.5 mg/g 45802-0495-35 Padagis 1 tube $0.398 AB Availability likely save 41%
Desoximetasone 2.5 mg/g 68180-0950-01 Lupin 1 tube $0.398 AB Availability likely save 41%
Desoximetasone 2.5 mg/g 71656-0087-15 Saptalis 15 tubes $0.398 AB Availability likely save 41%
Desoximetasone 2.5 mg/g 51672-1270-01 Sun 1 tube $0.410 AB Availability likely save 40%
Desoximetasone 2.5 mg/g 51672-1262-01 Sun 1 tube $0.680 — FDA listed —
Desoximetasone 2.5 mg/gthis 68462-0531-17 Glenmark 15 g $0.680 — FDA listed —
Desoximetasone 2.5 mg/g 40032-0024-60 Novel 1 tube — AB FDA listed —
desoximetasone 2.5 mg/g 63629-8641-01 Bryant 1 tube — AB FDA listed —
desoximetasone 2.5 mg/g 63629-8642-01 Bryant 1 tube — AB FDA listed —
desoximetasone 2.5 mg/g 70771-1166-00 Zydus 1 tube — AB FDA listed —
desoximetasone 2.5 mg/g 72162-1414-02 Bryant 1 tube — AB FDA listed —
Desoximetasone 2.5 mg/g 63187-0646-15 Proficient 1 tube — AB FDA listed —
Desoximetasone 2.5 mg/g 71205-0271-15 Proficient 1 tube — AB FDA listed —
Desoximetasone 2.5 mg/g 50090-5571-00 A-S 1 tube — AB FDA listed —
Desoximetasone 2.5 mg/g 50090-0597-00 A-S 1 tube — AB FDA listed —
Desoximetasone 2.5 mg/g 72162-2330-02 Bryant 1 tube — AB FDA listed —
desoximetasone 2.5 mg/g 70771-1437-00 Zydus 1 tube — AB 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

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA202838 (ANDA)
Labeler code68462
First marketedSep 2013
Product typeHuman Prescription Drug
Portfolio343 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 21 words ▾

INDICATIONS AND USAGE Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 22 words ▾

DOSAGE AND ADMINISTRATION Apply a thin film of desoximetasone ointment USP, 0.25% to the affected skin areas twice daily. Rub in gently.

⛔ Contraindications 23 words ▾

CONTRAINDICATIONS Desoximetasone ointment USP, 0.25% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

⚠️ Warnings 7 words ▾

WARNINGS Keep out of reach of children.

🤒 Adverse Reactions 87 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 In controlled clinical studies the incidence of adverse reactions was low (0.3%) for desoximetasone ointment 0.25 % and consisted of development of comedones at the site of application.

🤰 Pregnancy 135 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of desoximetasone ointment USP, 0.25%.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, desoximetasone ointment USP, 0.25% 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 135 words ▾

Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression andCushing'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 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. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Safety and effectiveness of Desoximetasone Ointment in pediatric patients below the age of 10 have not been established.

🆘 Overdosage 17 words ▾

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

🧬 Clinical Pharmacology ~1 min read ▾

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.

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. Pharmacokinetic studies in men with desoximetasone ointment USP, 0.25% with tagged desoximetasone showed no detectable level (limit of sensitivity: 0.003 μg/mL) in 1 subject and 0.004 and 0.006 μg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces.

Seven days after application, no further radioactivity was detected in urine or feces. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.

📦 How Supplied / Storage and Handling 74 words ▾

HOW SUPPLIED Desoximetasone Ointment USP, 0.25% is supplied in 15 gram tubes (NDC 68462-531-17) and 60 gram tubes (NDC 68462-531-65) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road District: Solan, Himachal Pradesh – 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions?

1 (888)721-7115 www.glenmarkpharma.com/usa September 2014

📋 Description 94 words ▾

DESCRIPTION Desoximetasone ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone ointment USP, 0.25% contains 2.5 mg of desoximetasone USP in an ointment base consisting of fractionated coconut oil and white petrolatum.

The chemical name of desoximetasone USP is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone USP has the molecular formula C 22 H 29 FO 4 and a molecular weight of 376.46. The CAS Registry Number is 382-67-2.

The structural formula is: Structure

💬 Information for Patients 137 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 dressings. • Other corticosteroid-containing products should not be used with desoximetasone ointment USP, 0.25% without first consulting with the physician.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.

Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation.

Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, desoximetasone ointment USP, 0.25% should be discontinued until the infection has been adequately treated.

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 dressings. • Other corticosteroid-containing products should not be used with desoximetasone ointment USP, 0.25% without first consulting with the physician.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician. Laboratory Tests The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Desoximetasone was nonmutagenic in the Ames test. Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 58 words ▾

Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

🧬 Pharmacokinetics ~1 min read ▾

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. 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.

Pharmacokinetic studies in men with desoximetasone ointment USP, 0.25% with tagged desoximetasone showed no detectable level (limit of sensitivity: 0.003 μg/mL) in 1 subject and 0.004 and 0.006 μg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces. Seven days after application, no further radioactivity was detected in urine or feces.

Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 33 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Desoximetasone was nonmutagenic in the Ames test.

📄 Package Label / Principal Display Panel 21 words ▾

Package/Label Display Panel NDC 68462-531-65 Desoximetasone Ointment USP, 0.25% For topical use only. Not for oral, ophthalmic, or intravaginal use. desoximetasone-carton

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

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

Medicare Part D (outpatient prescription) spending for Desoximetasone — the program that covers self-administered drugs. 6 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 Desoximetasone. 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
$632.4K
Claims incl. refills
9K
Beneficiaries
7.4K
Spend / beneficiary
$85.57
Spend / claim
$69.95
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.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Glenmark Pharmaceuticals Inc., USA. 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 g (68462-0531-65). 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?
Glenmark Pharmaceuticals Inc., USA 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.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.