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Alclometasone Dipropionate .5 mg/g Cream, 45 g — NDC 0168-0263-45 (Billing 00168-0263-45)

by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. · 45 g in 1 TUBE

This is a package of 45 g of Alclometasone Dipropionate .5 mg/g Cream from E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., no longer marketed (first marketed Jul 2005), no longer in the FDA NDC Directory; retail pharmacies pay about $0.7247 per g (NADAC).

NDC 00168-0263-45
🏷️ FDA NDC (as labeled) 0168-0263-45 billing pads the labeler segment with a zero
This package
Contains45 g Cost per g$0.7247 NADAC Per package$32.61 / 45 g Pack sizes3 compare ↓
Also priced by: Part D plans $1.44/unit — full pricing hub ↓
Product page 00168-0263-60 Also comes in: 15 g 0168-0263-15 60 g 0168-0263-60
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0168-0263-45 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0168 labeler · 0263 product · 45 package
Package marketed since
Jul 12, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
45 g per package
Barcode (UPC)
0301680263151
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0168-0263-45
Product NDC 0168-0263
11-digit billing NDC 00168026345
NCPDP billing unit GM — per gram (weight)
RxCUI 855474
UNII S56PQL4N1V
UPC 0301680263151
Application # ANDA076973
SPL Set ID 6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Dec 2025)
Marketing start 2005-07-12
Route TOPICAL
Dosage form CREAM
Substance ALCLOMETASONE DIPROPIONATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90550005103710
GPI class Alclometasone Dipropionate
GCN Seq No 007636
GCN 33710
HICL code 003328
Ingredient (HICL) Alclometasone Dipropionate
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 ALCLOMETASONE DIPRO 0.05% CRM
FDB brand name Alclometasone Dipropionate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007636
  • GCN: 33710
  • GPI-14 (Medi-Span): 90550005103710
  • HICL (First Databank): 003328
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 855474
Why two NDCs? The FDA registers this code as 0168-0263-45 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00168-0263-45. 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, moderately potent (group II), Corticosteroids, plain
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 ALCLOMETASONE DIPRO 0.05% CRM Ingredient Alclometasone Dipropionate

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.

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 $0.725 $32.61 / 45 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 $1.44 $64.92 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $1.382 $0.535
▼ Down 23% over the last 13 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
00168-0263-15 0168-0263-15 15 g in 1 TUBE $0.9066 / g $13.60 2005-07-12 — Discontinued by firm
00168-0263-45 You're viewing this 45 g in 1 TUBE $0.7247 / g $32.61 2005-07-12 — Discontinued by firm
00168-0263-60 0168-0263-60 Main listing 60 g in 1 TUBE $1.25 / g $74.89 2005-07-12 — Discontinued by firm

You're viewing one of 3 pack sizes for this product.

This pack has the lowest per-g cost of the 3 priced pack sizes ($0.7247 NADAC).

This pack shows little to no recent Medicaid volume — the 60 g pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 45 g — 45 g in 1 tube.
How does this package differ from NDC 00168-0263-15?
Both are Alclometasone Dipropionate .5 mg/g Cream — the drug itself is identical. This page's package is the 45 g one, while NDC 00168-0263-15 is the 15 g package. Per-g NADAC also differs: $0.7247 here vs $0.9066 for the 15 g pack.
What NDC number is used to bill for this package of Alclometasone Dipropionate .5 mg/g Cream?
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
Alclometasone Dipropionate .5 mg/gthis 00168-0263-45 E. 45 g $0.725 AB Discontinued —
Alclometasone Dipropionate .5 mg/g 68462-0299-17 Glenmark 15 g $0.803 — FDA listed +11%
Alclometasone Dipropionate .5 mg/g 51672-1316-01 Sun 1 tube $0.861 AB Availability likely +19%
Alclometasone dipropionate .5 mg/g 51672-1306-01 Sun 1 tube $2.187 AB Availability likely +202%
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

🏛️
2005
On the market since
Jul 2005
📍
2026
Currently FDA-listed
21 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA076973 (ANDA)
Labeler code00168
First marketedJul 2005
Product typeHuman Prescription Drug
Portfolio7 products on file

More NDCs from E. Fougera & Co. a division of Fougera Pharmaceu... labeler code 00168

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 ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 92 words ▾

INDICATIONS AND USAGE: Alclometasone dipropionate cream is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate cream have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.

⏱️ Dosage and Administration 181 words ▾

DOSAGE AND ADMINISTRATION: Apply a thin film of alclometasone dipropionate cream to the affected skin areas two or three times daily; massage gently until the medication disappears. Alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream in pediatric patients for more than 3 weeks of use have not been established.

Use in pediatric patients under 1 year of age is not recommended. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Alclometasone dipropionate cream should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing. Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with alclometasone dipropionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS: Alclometasone dipropionate cream is contraindicated in those patients with a history of hypersensitivity to any of the components in these preparations.

🤒 Adverse Reactions 77 words ▾

ADVERSE REACTIONS: The following local adverse reactions have been reported with alclometasone dipropionate cream in approximately 2% of patients: itching, burning, erythema, dryness, irritation, and papular rashes. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use: Alclometasone dipropionate cream may be used with caution in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Use of alclometasone dipropionate cream is supported by results from adequate and well-controlled studies in pediatric patients with corticosteroid-responsive dermatoses. Since the safety and efficacy of alclometasone dipropionate cream has not been established in pediatric patients below 1 year of age, its use in this age-group is not recommended.

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 and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children.

Pediatric patients applying alclometasone dipropionate cream to >20% of the body surface area are at higher risk for HPA axis suppression. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Alclometasone dipropionate cream should not be used in the treatment of diaper dermatitis.

🧓 Geriatric Use 116 words ▾

Geriatric Use: A limited number of patients at or above 65 years of age have been treated with alclometasone dipropionate cream in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety. A single adverse reaction reported with alclometasone dipropionate cream in this population was similar to those reactions reported by younger patients.

Based on available data, no adjustment of dosage of alclometasone dipropionate cream in geriatric patients is warranted.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with alclometasone dipropionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

🆘 Overdosage 19 words ▾

OVERDOSAGE: Topically applied alclometasone dipropionate cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY: Like other topical corticosteroids, alclometasone dipropionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.

Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

A study utilizing a radio labeled alclometasone dipropionate cream formulation was performed to measure systemic absorption and excretion. Results indicated that approximately 3% of the steroid was absorbed during 8 hours of contact with intact skin of normal volunteers. Studies performed with alclometasone dipropionate cream indicate that this product is in the low to medium range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 50 words ▾

HOW SUPPLIED: Alclometasone dipropionate cream USP, 0.05% is supplied in 15 gram tube NDC 0168-0263-15 45 gram tube NDC 0168-0263-45 60 gram tube NDC 0168-0263-60 Store between 2° and 30‑°C (36° and 86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2263D R08/12 #69

📋 Description 117 words ▾

DESCRIPTION: Alclometasone dipropionate cream contains alclometasone dipropionate (7α-chloro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, alclometasone dipropionate is C 28 H 37 ClO 7 .

It has the following structural formula: Alclometasone dipropionate has the molecular weight of 521. It is a white powder, insoluble in water, slightly soluble in propylene glycol, and moderately soluble in hexylene glycol. Each gram of alclometasone dipropionate cream contains 0.5 mg of alclometasone dipropionate in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetostearyl alcohol, glyceryl monostearate, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water. structure.jpg

💬 Information for Patients 179 words ▾

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. 2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician. 4.

Patients should report to their physician any signs of local adverse reactions. 5. Parents of pediatric patients should be advised not to use alclometasone dipropionate cream in the treatment of diaper dermatitis.

Alclometasone dipropionate cream should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION ). 6. This medication should not be used on the face, underarms, or groin areas unless directed by the physician.

7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 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 glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.The effects of alclometasone dipropionate cream on the HPA axis have been evaluated. In one study, alclometasone dipropionate cream was applied to 30% of the body twice daily for 7 days, and occlusive dressings were used in selected patients either 12 hours or 24 hours daily. In another study, alclometasone dipropionate cream was applied to 80% of the body surface of normal subjects twice daily for 21 days with daily 12-hour periods of whole body occlusion.

Average plasma and urinary free cortisol levels and urinary levels of 17-hydroxysteroids were decreased (about 10%), suggesting suppression of the HPA axis under these conditions. Plasma cortisol levels have also been demonstrated to decrease in pediatric patients treated twice daily for 3 weeks without occlusion. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface area to body mass ratios (see PRECAUTIONS: Pediatric Use ). If irritation develops, alclometasone dipropionate cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids.

Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of alclometasone dipropionate cream should be discontinued until the infection has been adequately controlled.

In a transgenic mouse study, chronic use of alclometasone dipropionate cream led to an increased number of animals with benign neoplasms of the skin at the treatment site (see PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility ). The clinical relevance of the findings in animal studies to humans is not clear. Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: 1.

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. This medication should not be used for any disorder other than that for which it was prescribed. 3.

The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician. 4. Patients should report to their physician any signs of local adverse reactions.

5. Parents of pediatric patients should be advised not to use alclometasone dipropionate cream in the treatment of diaper dermatitis. Alclometasone dipropionate cream should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTR… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 68 words ▾

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when alclometasone dipropionate cream is administered to a nursing woman.

🧬 Pharmacokinetics 135 words ▾

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin may increase percutaneous absorption. A study utilizing a radio labeled alclometasone dipropionate cream formulation was performed to measure systemic absorption and excretion. Results indicated that approximately 3% of the steroid was absorbed during 8 hours of contact with intact skin of normal volunteers.

Studies performed with alclometasone dipropionate cream indicate that this product is in the low to medium range of potency as compared with other topical corticosteroids.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 109 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility : Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of alclometasone dipropionate. The effects of alclometasone dipropionate on mutagenesis or fertility have not been evaluated. In a 26-week dermal carcinogenicity study conducted in transgenic (Tg.AC) mice, topical application once daily of both the vehicle cream and the 0.05% alclometasone dipropionate cream significantly increased the incidence of benign neoplasms of the skin in both sexes at the treatment site when compared to untreated controls.

This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.

📄 Package Label / Principal Display Panel 82 words ▾

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0263-15 FOUGERA ® ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% Rx only FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE WARNING: Keep out of reach of children. NET WT 15 grams 15gramtube

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0263-15 FOUGERA ® ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% Rx only NOT FOR OPHTHALMIC USE FOR DERMATOLOGIC USE ONLY WARNING: Keep out of reach of children. NET WT 15 grams 15gramcarton.jpg

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

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.
60 g00168-0263-60 152 Rx · $7,813
15 g00168-0263-15 29 Rx · $1,537
45 g this page00168-0263-45 No Medicaid data
Drug total (last 4 qtrs): 181 Rx · 12,600 units · $9,350 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 Alclometasone Dipropionate — 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 Alclometasone Dipropionate. 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
$167.6K
Claims incl. refills
3.3K
Beneficiaries
3K
Spend / beneficiary
$56.07
Spend / claim
$50.16
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 No longer marketed (per FDA listing data)
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 ✓ 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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 15 g (00168-0263-15), 60 g (00168-0263-60). 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?
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 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.
← 00168-0258-15 · E. 00168-0267-30 · E. →
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.