HomeNDC LookupIngredientsAlclometasone Dipropionate › 68462-0299-17
Alclometasone Dipropionate .5 mg/g Ointment, 15 g — NDC 68462-0299-17 package photo

Alclometasone Dipropionate .5 mg/g Ointment, 15 g

by Glenmark Pharmaceuticals Inc., USA · 15 g in 1 TUBE (68462-299-17)
NDC 68462-0299-17
🏷️ FDA NDC (as labeled) 68462-299-17 billing pads the product segment with a zero
This package
Contains15 g Cost per g$0.8031 NADAC Per package$12.05 / 15 g Pack sizes3 compare ↓
Also priced by: Part D plans $0.7397/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 68462-299-17
Product NDC 68462-299
11-digit billing NDC 68462029917
NCPDP billing unit GM — per gram (weight)
RxCUI 855474, 855480
UNII S56PQL4N1V
Application # ANDA079227
SPL Set ID 63e635e0-65d8-4b30-9f2a-ab16deba90bd
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 2009-07-30
Route TOPICAL
Dosage form OINTMENT
Substance ALCLOMETASONE DIPROPIONATE
GPI-14 90550005104210
GPI class Alclometasone Dipropionate
GCN Seq No 007637
GCN 33730
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 DIPR 0.05% OINT
FDB brand name Alclometasone Dipropionate
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68462-299-17 — 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 → 68462-0299-17. 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, 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.

🏭 Manufacturer & labeler

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA079227 (ANDA)
Labeler code68462
First marketedJul 2009
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.

🩺 Clinical

Label name ALCLOMETASONE DIPR 0.05% OINT Ingredient Alclometasone Dipropionate
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • 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 F76354LMGR
    A synthetic fatty acid compound derived from propylene glycol and palm oil. It works as an emulsifier to blend oil and water-based ingredients, and as a thickener to improve texture and stability in the medicine.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

4 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 DailyMedingredient 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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.803 $12.05 / 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 $0.7397 $11.10 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Oct 2021 Apr 2022 Oct 2022 Feb 2024 $1.217 $0.803
▼ Down 34% over the last 10 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alclometasone Dipropionate .5 mg/gthis 68462-0299-17 Glenmark 15 g $0.803 FDA listed
Alclometasone Dipropionate .5 mg/g 51672-1316-01 Sun 1 tube $0.896 AB Availability likely +12%
Alclometasone Dipropionate .5 mg/g 00168-0263-15 E. 15 g $0.907 AB FDA listed +13%
Alclometasone dipropionate .5 mg/g 51672-1306-01 Sun 1 tube $2.204 AB Availability likely +174%
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

🏛️
2009
On the market since
Jul 2009
📍
2026
Currently FDA-listed
17 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Alclometasone Dipropionate — the ingredient across all brands.

Top reported reactions

Rash29
Pruritus28
Diarrhoea18
Nausea16
Fatigue13
Dermatitis Atopic12
Erythema12

Age at onset

Infant4
Child19
Adolescent8
Adult58
Elderly33

Reporter sex

309 reports
Male · 42%
Female · 58%

Serious outcomes

Hospitalization73
Death16
Life-threatening7
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 49 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
68462-0299-17 You're viewing this 15 g in 1 TUBE (68462-299-17) $0.8031 / g $12.05 2009-07-30 Active
68462-0299-47 45 g in 1 TUBE (68462-299-47) $1.23 / g $55.43 2009-07-30 Active
68462-0299-65 60 g in 1 TUBE (68462-299-65) 2009-07-30 Active

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

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.8031 NADAC).

Pack size FAQ

What quantity is in NDC 68462-0299-17?
NDC 68462-0299-17 contains 15 g — 15 g in 1 tube.
What is the difference between NDC 68462-0299-17 and NDC 68462-0299-47?
Both are Alclometasone Dipropionate .5 mg/g Ointment — the drug itself is identical. NDC 68462-0299-17 is the 15 g package, while NDC 68462-0299-47 is the 45 g package. Per-g NADAC also differs: $0.8031 here vs $1.23 for the 45 g pack.
What NDC number is used to bill for this package of Alclometasone Dipropionate .5 mg/g Ointment?
Bill NDC 68462-0299-17 — the 11-digit billing format is 68462029917. 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 97 words

INDICATIONS AND USAGE Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment 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 and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

⏱️ Dosage and Administration 194 words

DOSAGE AND ADMINISTRATION Apply a thin film of alclometasone dipropionate cream or ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of alclometasone dipropionate cream or ointment 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 or ointment should not be used with occlusive dressings unless directed by a physician. Alclometasone dipropionate cream or ointment 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 or ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

Contraindications 24 words

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

🤒 Adverse Reactions 99 words

ADVERSE REACTIONS The following local adverse reactions have been reported with alclometasone dipropionate cream in approximately 2% of patients: itching and burning, erythema, dryness, irritation, and papular rashes. The following local adverse reactions have been reported with alclometasone dipropionate ointment in approximately 1% of patients: itching, burning, and erythema. 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.

🤰 Pregnancy 67 words

Pregnancy Teratogenic Effects 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. There are no adequate and well-controlled studies in pregnant women.

Alclometasone dipropionate cream or ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use ~1 min read

Pediatric Use Alclometasone dipropionate cream and ointment 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 and ointment 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 and ointment have 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 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 or ointment to >20% of the body surface area are at higher risk for HPA axis suppression. HPA axis suppression, Cushing 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 or ointment should not be used in the treatment of diaper dermatitis.

🧓 Geriatric Use 95 words

Geriatric Use A limited number of patients at or above 65 years of age have been treated with alclometasone dipropionate cream and ointment in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety. No adverse events were reported with alclometasone dipropionate ointment in geriatric patients, and the 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 and ointment in geriatric patients is warranted.

🆘 Overdosage 21 words

OVERDOSAGE Topically applied alclometasone dipropionate cream and ointment 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 ointment 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 and ointment indicate that these products are in the low to medium range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 56 words

HOW SUPPLIED Alclometasone Dipropionate Cream USP, 0.05% is supplied in: 15 gram tubes (NDC 68462-300-17) 45 gram tubes (NDC 68462-300-47) 60 gram tubes (NDC 68462-300-65) Alclometasone Dipropionate Ointment USP, 0.05% is supplied in: 15 gram tubes (NDC 68462-299-17) 45 gram tubes (NDC 68462-299-47) 60 gram tubes (NDC 68462-299-65) Store between 2°C and 30°C (36°F and 86°F).

📦 Storage and Handling 8 words

Store between 2°C and 30°C (36°F and 86°F).

📋 Description 160 words

DESCRIPTION Alclometasone Dipropionate Cream USP, 0.05% and Alclometasone Dipropionate Ointment USP, 0.05% contain alclometasone dipropionate, USP (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, USP is C 28 H 37 ClO 7 .

It has the following structural formula: Alclometasone dipropionate, USP has the molecular weight of 521.04 g/mol. It is a white to almost white crystalline powder, sparingly soluble in alcohol, acetone, ethyl acetate and acetonitrile. Each gram of Alclometasone Dipropionate Cream USP contains 0.5 mg of alclometasone dipropionate, USP in a hydrophilic, emollient cream base of propylene glycol, white petrolatum, cetearyl alcohol, mono and di-glycerides, PEG 100 stearate, ceteth-20, monobasic sodium phosphate, chlorocresol, phosphoric acid, and purified water.

Each gram of Alclometasone Dipropionate Ointment USP contains 0.5 mg of alclometasone dipropionate, USP in an ointment base of hexylene glycol, white wax, propylene glycol monopalmitostearate, and white petrolatum. structure-formula

💬 Information for Patients 183 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 or ointment in the treatment of diaper dermatitis.

Alclometasone dipropionate cream or ointment 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.

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