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Betamethasone Dipropionate .5 mg/g Ointment — NDC 00472-0381-45 package photo

Betamethasone Dipropionate .5 mg/g Ointment

by Actavis Pharma, Inc. · 1 TUBE in 1 CARTON (0472-0381-45) / 45 g in 1 TUBE
NDC 00472-0381-45
🏷️ FDA NDC (as labeled) 0472-0381-45 billing pads the labeler segment with a zero
This package
Contains45 g in 1 tube Cost per g$0.3494 NADAC Per package$15.72 / 45 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.7137/unit · Part D plans $1.11/unit — full pricing hub ↓
Also comes in: 15 g 00472-0381-15
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 10, 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) 0472-0381-45
Product NDC 0472-0381
11-digit billing NDC 00472038145
NCPDP billing unit GM — per gram (weight)
RxCUI 197405
UNII 826Y60901U
Application # ANDA071012
SPL Set ID aa3f4012-7597-422d-8bcc-00102780a152
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 1997-02-01
Route TOPICAL
Dosage form OINTMENT
Substance BETAMETHASONE DIPROPIONATE
GCN Seq No 007569
GCN 31070
HICL code 003304
Ingredient (HICL) Betamethasone 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 68:04.00.00
AHFS class Adrenals
FDB label name BETAMETHASONE DP 0.05% OINT
FDB brand name Betamethasone Dipropionate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0472-0381-45 — 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 → 00472-0381-45. 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 acting locally, Corticosteroids, Corticosteroids, potent (group III)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerActavis Pharma, Inc.
Application holderACTAVIS MID ATLANTIC LLC
FDA applicationANDA071012 (ANDA)
Labeler code00472
First marketedFeb 1997
Product typeHuman Prescription Drug
Portfolio324 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 BETAMETHASONE DP 0.05% OINT Ingredient Betamethasone Dipropionate
📖 What it is MedlinePlus · NLM

Betamethasone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, 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). Betamethasone 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
  • Betamethasone is a steroid cream (or ointment, gel, spray, or foam) that treats skin conditions where inflammation is the problem — things like eczema, psoriasis, and other conditi...
  • What skin conditions does betamethasone treat?
  • For creams and ointments, apply a thin layer to the affected area once or twice a day — less is more with these products. For the spray (like Sernivo), shake it well first, spray o...
  • That depends on the product. Most creams and ointments should be used for no more than 2 consecutive weeks. The spray forms — including Sernivo — are approved for up to 4 weeks. Yo...
📖 Read our full Betamethasone guide →
8
Nutrient depletion considerations

Betamethasone Dipropionate may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.349 $15.72 / 45 g
Medicaid paysCMS SDUD · 12 mo $0.7137 $32.12 / 45 g
Medicare drug plans payPart D · Q2 2026 $1.11 $49.99 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.517 $0.349
▼ Down 75% over the last 24 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
Betamethasone Dipropionate .5 mg/g 45802-0376-32 Padagis 1 tube $0.124 AB Availability likely save 64%
Betamethasone Dipropionate .5 mg/g 68462-0290-17 Glenmark 15 g $0.200 — FDA listed save 43%
Betamethasone Dipropionate .5 mg/g 51672-1310-01 Sun 1 tube $0.209 AB Availability likely save 40%
Betamethasone Dipropionate .5 mg/g 45802-0021-46 Padagis 56.2 g $0.292 AB Availability likely save 16%
Betamethasone Dipropionate .5 mg/gthis 00472-0381-45 Actavis 1 tube $0.349 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 00168-0056-15 E. 1 tube $0.460 AB Discontinued +32%
Betamethasone Dipropionate .5 mg/g 45802-0505-14 Padagis 1 tube $0.460 AB Availability likely +32%
Betamethasone Dipropionate USP, 0.05% .5 mg/g 52817-0824-15 TruPharma 1 tube $0.460 AB Availability likely +32%
betamethasone dipropionate .5 mg/g 72578-0093-01 Viona 1 tube $0.460 AB Availability likely +32%
Betamethasone dipropionate .5 mg/g 70710-1233-01 Zydus 1 tube $0.465 AB Availability likely +33%
Betamethasone Dipropionate .5 mg/g 00713-0659-15 Cosette 1 tube $0.465 AB Availability likely +33%
Betamethasone Dipropionate .5 mg/g 00472-0380-15 Actavis 1 tube $0.465 AB Availability likely +33%
Betamethasone Dipropionate .5 mg/g 00168-0055-15 E. 1 tube $0.465 AB Availability likely +33%
Betamethasone dipropionate .5 mg/g 16714-0996-01 Northstar 1 tube $0.465 AB Availability likely +33%
Betamethasone Dipropionate .5 mg/g 51672-1274-01 Sun 1 tube $0.465 AB Availability likely +33%
Betamethasone Dipropionate .5 mg/g 66993-0897-15 Prasco 1 tube $0.578 AB Availability likely +66%
Betamethasone Dipropionate .5 mg/g 00472-0382-15 Actavis 1 tube $0.588 AB Discontinued +68%
Betamethasone Dipropionate .5 mg/g 35573-0107-15 Burel 1 tube $0.588 AB Availability likely +68%
Betamethasone dipropionate .5 mg/g 68180-0947-01 Lupin 1 tube $0.588 AB Availability likely +68%
Betamethasone Dipropionate .5 mg/g 00168-0268-15 E. 15 g $0.588 AB Availability likely +68%
Betamethasone Dipropionate .5 mg/g 51672-1309-01 Sun 1 tube $2.740 AB Availability likely +684%
Betamethasone Dipropionate .5 mg/g 50090-0236-00 A-S 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 63629-9323-01 Bryant 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 63629-9324-01 Bryant 1 tube — AB FDA listed —
betamethasone dipropionate .5 mg/g 70771-1550-01 Zydus 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 71335-2715-01 Bryant 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 72162-1415-02 Bryant 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 71205-0275-15 Proficient 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 50090-0235-00 A-S 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 50090-2182-00 A-S 1 tube — AB FDA listed —
Betamethasone dipropionate .5 mg/g 50090-4680-00 A-S 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 63629-8614-01 Bryant 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 59651-0699-14 Aurobindo 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 70518-4187-00 REMEDYREPACK 1 tube — AB FDA listed —
Diprolene .5 mg/g 78206-0124-01 Organon 1 tube — AB FDA listed —
Betamethasone dipropionate .5 mg/g 70771-1380-01 Zydus 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 68071-4556-03 NuCare 30 g — AB FDA listed —
Betamethasone dipropionate .5 mg/g 50090-6787-00 A-S 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 59651-0891-14 Aurobindo 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 76420-0858-15 Asclemed 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 50090-3276-00 A-S 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 68788-7670-05 Preferred 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 50090-7517-00 A-S 50 g — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 68788-9219-01 Preferred 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 72162-1405-02 Bryant 1 tube — AB FDA listed —
Betamethasone dipropionate .5 mg/g 50090-7525-00 A-S 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 51407-0273-15 Golden 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 63629-8613-01 Bryant 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 50090-5232-00 A-S 1 tube — AB FDA listed —
Betamethasone Dipropionate .5 mg/g 68071-4814-05 NuCare 15 g — AB FDA listed —
Betamethasone dipropionate .5 mg/g 67296-2275-01 Redpharm 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

🏛️
1997
On the market since
Feb 1997
📍
2026
Currently FDA-listed
29 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00472-0381-45, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.5K
Units reimbursed last 4 qtrs
72.9K
Gross reimbursed last 4 qtrs
$52K
Avg / prescription
$34.18
Avg / unit
$0.7137
Latest quarter Q1 2026
206Rx
Medicaid pays / g
$0.7137
gross reimbursed
vs
NADAC / g
$0.3494
acquisition cost
=
Spread
+$0.3643
+104% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
75% FFS 25% MCO
Fee-for-service · 1,144 Rx Managed care · 378 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 1,365 units · 69.5 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 12,655 units · 126 per 100k residents MI New York: 32,910 units · 168 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 390 units · 4.2 per 100k residents NJ Massachusetts: 3,691 units · 52.7 per 100k residents MA California: 19,275 units · 49.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 630 units · 13.9 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: 630 units · 57.5 per 100k residents RI Arizona: no data reported AZ New Mexico: 1,350 units · 63.9 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.2168
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 168 /100k
2 Michigan 126 /100k
3 Idaho 69.5 /100k
4 New Mexico 63.9 /100k
5 Rhode Island 57.5 /100k
6 Massachusetts 52.7 /100k
7 California 49.5 /100k
8 Kentucky 13.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube this page00472-0381-45 1,522 Rx · $52,026
1 tube00472-0381-15 1,348 Rx · $28,334
Drug total (last 4 qtrs): 2,870 Rx · 104,426 units · $80,359 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 Betamethasone Dipropionate — the program that covers self-administered drugs. 9 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 Betamethasone 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
$6.42M
Claims incl. refills
175.3K
Beneficiaries
137.3K
Spend / beneficiary
$46.78
Spend / claim
$36.64
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 BETAMETHASONE DIPROPIONATE — the ingredient across all brands.

Top reported reactions

Psoriasis1,124
Nausea709
Pruritus640
Pain620
Headache585
Diarrhoea580
Fatigue573

Age at onset

Neonate11
Infant4
Child51
Adolescent45
Adult1,534
Elderly821

Reporter sex

10,032 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization2,756
Death656
Life-threatening504
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1,144 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
00472-0381-15 1 TUBE in 1 CARTON (0472-0381-15) / 15 g in 1 TUBE $0.4599 / g $6.90 1997-02-01 Active
00472-0381-45 You're viewing this 1 TUBE in 1 CARTON (0472-0381-45) / 45 g in 1 TUBE $0.3494 / g $15.72 1997-02-01 Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.3494 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 53% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00472-0381-45?
NDC 00472-0381-45 is listed by the FDA — 1 tube in 1 carton / 45 g in 1 tube.
What NDC number is used to bill for this package of Betamethasone Dipropionate .5 mg/g Ointment?
Bill NDC 00472-0381-45 — the 11-digit billing format is 00472038145. 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 28 words ▾

INDICATIONS AND USAGE Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.

⏱️ Dosage and Administration 41 words ▾

DOSAGE AND ADMINISTRATION Apply a thin film of betamethasone dipropionate ointment 0 . 05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary. Betamethasone dipropionate ointment is not to be used with occlusive dressings.

⛔ Contraindications 24 words ▾

CONTRAINDICATIONS Betamethasone dipropionate ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.

🤒 Adverse Reactions 184 words ▾

ADVERSE REACTIONS The following local adverse reactions are reported infrequently when betamethasone dipropionate ointment is used as recommended in the DOSAGE AND ADMINISTRATION section. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate ointment during a pediatric clinical study include signs of skin atrophy (telangiectasia, thinness, shininess, bruising, loss of skin markings).

Cutaneous atrophy of the face occurred in 1/6 (17%) of infants, 2/9 (22%) of 2 to 5 year olds, and 2/6 (33%) of the 6 to 8 year olds. Non-facial atrophy occurred in 15%, 8%, and 9% of 2 to 5 year olds, 6 to 8 year olds, and 9 to 12 year olds, respectively. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 17 words ▾

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

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY The corticosteroids are a class of compounds comprising steroid hormones, secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions.

However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. 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 (see DOSAGE AND ADMINISTRATION ).

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 (see DOSAGE AND ADMINISTRATION ).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. 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. Eighty pediatric patients ages 6 months to 12 years, with atopic dermatitis, were enrolled in an open-label hypothalamic-pituitary-adrenal (HPA) axis safety study. Betamethasone dipropionate ointment was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 99%).

In 15 of 53 (28%) evaluable patients, adrenal suppression was indicated by either a pre-stimulated cortisol concentration less than or equal to 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol less than or equal to 18 mcg/dL and an increase of less than 7 mcg/dL from the baseline cortisol. Follow-up testing 2 weeks after study completion available for 2 of the 15 patients demonstrated a normally responsive HPA axis. Studies performed with betamethasone dipropionate ointment indicate that it is in the high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 46 words ▾

HOW SUPPLIED Betamethasone dipropionate ointment, USP 0 . 05% is available in: 15 gram (0 . 53 oz) NDC 0472-0381-15 45 gram (1 . 59 oz) NDC 0472-0381-45 Store between 15° to 30°C (59° to 86°F). Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. B 2/2023

📋 Description 117 words ▾

DESCRIPTION Betamethasone dipropionate ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-Fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504 . 6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate ointment 0 .

05% contains: 0 . 64 mg betamethasone dipropionate, USP (equivalent to 0 . 5 mg betamethasone) in an ointment base consisting of mineral oil and white petrolatum.

14c51497-figure-01

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