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Halobetasol Propionate .5 mg/g Ointment — NDC 21922-108-04 (Billing 21922-0108-04)

by Encube Ethicals, Inc. · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Halobetasol Propionate .5 mg/g Ointment from Encube Ethicals, Inc., marketed since Jul 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 21922-0108-04
🏷️ FDA NDC (as labeled) 21922-108-04 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Pack sizes2 compare ↓
Main listing for product 21922-108 · Also comes in: 50 g 21922-108-14
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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 21922-108-04
Product NDC 21922-108
11-digit billing NDC 21922010804
RxCUI 977978
UNII 91A0K1TY3Z
Application # ANDA209978
SPL Set ID d4f03a79-3d5e-4a39-8ab0-8ebd3d804e39
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-01
Route TOPICAL
Dosage form OINTMENT
Substance HALOBETASOL PROPIONATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 977978
Why two NDCs? The FDA registers this code as 21922-108-04 — 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 → 21922-0108-04. 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

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Halobetasol Propionate (3 interactions) — ranked by severity →
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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 50 g
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 Marketing startMarketing endStatus
21922-0108-04 You're viewing this Main listing 1 TUBE in 1 CARTON / 15 g in 1 TUBE 2026-07-01 — Active
21922-0108-14 21922-108-14 1 TUBE in 1 CARTON / 50 g in 1 TUBE 2026-07-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Halobetasol Propionate .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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Halobetasol Propionate .5 mg/g 45802-0131-32 Padagis 1 tube $0.397 AB Availability likely —
Halobetasol Propionate .5 mg/g 45802-0129-32 Padagis 1 tube $0.409 AB Availability likely —
Halobetasol Propionate .5 mg/g 00713-0640-15 Cosette 15 g $0.648 AB Availability likely —
Halobetasol Propionate .5 mg/g 70752-0119-02 QUAGEN 1 tube $0.843 AB Availability likely —
Halobetasol Propionate .5 mg/g 00713-0339-15 Cosette 1 tube $0.843 AB Availability likely —
Ultravate .5 mg/g 73159-0008-60 Lacer 1 bottle — — FDA listed —
Halobetasol Propionate .5 mg/g 72162-2258-02 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 85437-0008-60 Coral 1 bottle — — FDA listed —
Halobetasol Propionate .5 mg/g 63629-8665-01 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 72162-1396-02 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 72162-2331-02 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 63629-8664-01 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/g 72162-2067-02 Bryant 1 tube — AB FDA listed —
Halobetasol Propionate .5 mg/gthis 21922-0108-04 Encube 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 8S4V89348V
    A synthetic resin derived from allyl alcohol and pentaerythritol. It functions as a binder and film-former in tablet coatings and solid formulations, helping hold ingredients together and create a protective layer.
  • UNII U6XF9NP8HM
    Aluminum stearate is a salt made from aluminum and stearic acid, a fatty substance. It works as a lubricant and glidant to help powder flow smoothly during manufacturing and tablet production.
  • UNII YWW937R1QR
    A fatty acid derivative made by combining citric acid with stearic acid. It acts as an emulsifier and dispersing agent to help mix oils and water-based ingredients together in the medicine.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerEncube Ethicals, Inc.
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA209978 (ANDA)
Labeler code21922
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio77 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 97 words ▾

INDICATIONS AND USAGE Halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

⏱️ Dosage and Administration 93 words ▾

DOSAGE AND ADMINISTRATION Apply a thin layer of halobetasol propionate ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Halobetasol propionate ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. 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. Halobetasol propionate ointment should not be used with occlusive dressings.

⛔ Contraindications 23 words ▾

CONT RAINDICATIONS Halobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 120 words ▾

ADV ERSE REACTIONS In controlled clinical trials, the most frequent adverse events reported for halobelasol propionate ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash. The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as halobetasol propionate ointment.

These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Pvt. Ltd. at 1-833-285-4151, contact the FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

🤰 Pregnancy 155 words ▾

Pregnancy Terato genic 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. Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits.

These doses are approximately 13, 33 and 3 limes, respectively, the human topical dose of halobetasol propionate ointment. Halobetasol propionate was embryotoxic in rabbits but not in rats. Cleft palate was observed in both rats and rabbits.

Omphalocele was seen in rats, but not in rabbits. There are no adequate and well-controlled studies of the teratogenic potential of halobetasol propionate in pregnant women. Halobetasol propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 146 words ▾

Pediatric Use Safety and effectiveness of halobetasol propionate ointment in pediatric patients have not been established and use in pediatric patients under 12 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 or after withdrawal of treatment.

Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

🧓 Geriatric Use 70 words ▾

Geriatric Use Of 850 patients treated with halobetasol propionate ointment in clinical studies, 21 % were 61 years and over and 6% were 71 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients; and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 19 words ▾

OVERDOSAGE Topically applied, halobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology 208 words ▾

CLINICAL PHARMACOLOGY Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, 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 rostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipaseA 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.

Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration of Halobetasol propionate ointment. Studies performed with halobetasol propionate ointment indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 70 words ▾

HOW SUPPLIED SECTION Halobetasol propionate ointment, 0.05% is supplied in the following tube size: 15 g (NDC 21922-108-04) 50 g (NDC21922-108-14) STORAGE Store halobetasol propionate ointment between 15°C to 30°C (59°F to 86°F). Manufactured by: Encube Ethicals Pvt. Ltd.

Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc.

200 Meredith Drive, Suite 202, Durham, NC 27713 USA Revised: 09/2025

📋 Description 104 words ▾

DESCRIPTION Halobetasol propionate ointment, 0.05% contains Halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti- inflammatory and antipruritic agent. Chemically halobetasol propionate is 21-chloro-6a, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna- 1, 4-diene-3-20-dione, 17-propionate, C 25 H 31 CIF 2 0 5 .

It has the following structural formula: Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water. Each gram of halobetasol propionate ointment contains 0.5mg/g of halobetasol propionate in a base of aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan sesquioleate, and stearyl citrate. str

💬 Information for Patients 91 words ▾

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

Avoid contact with the eyes. 2. The medication should not be used for any disorder other than that for which ii 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.

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 Halobetasol Propionate — the program that covers self-administered drugs. 4 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 Halobetasol Propionate. 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
$2.1M
Claims incl. refills
39.2K
Beneficiaries
28.4K
Spend / beneficiary
$73.82
Spend / claim
$53.58
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) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 Encube Ethicals, Inc.. 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 1 tube (21922-0108-14). 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?
Encube Ethicals, 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.
← 21922-0107-13 · Encube 21922-0109-16 · Encube →
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.