HomeNDC LookupIngredientsBetamethasone Dipropionate › 51407-0273-45
🧴image loading
(from DailyMed)

Betamethasone Dipropionate .5 mg/g Cream

by Golden State Medical Supply, Inc. · 1 TUBE in 1 CARTON (51407-273-45) / 45 g in 1 TUBE
NDC 51407-0273-45
🏷️ FDA NDC (as labeled) 51407-273-45 billing pads the product segment with a zero
This package
Contains45 g in 1 tube Pack sizes2 compare ↓
Also priced by: Part D plans $0.7627/unit — full pricing hub ↓
Also comes in: 15 g 51407-0273-15
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) 51407-273-45
Product NDC 51407-273
11-digit billing NDC 51407027345
NCPDP billing unit GM — per gram (weight)
RxCUI 238920
UNII 826Y60901U
UPC 0351407273451
Application # ANDA073552
SPL Set ID 9571a031-179d-7dfb-e053-2995a90aa016
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 1992-04-30
Route TOPICAL
Dosage form CREAM
Substance BETAMETHASONE DIPROPIONATE
GPI-14 90550020003705
GPI class Betamethasone Dipropionate
GCN Seq No 007568
GCN 31060
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% CRM
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 51407-273-45 — 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 → 51407-0273-45. 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

LabelerGolden State Medical Supply, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA073552 (ANDA)
Labeler code51407
First marketedApr 1992
Product typeHuman Prescription Drug
Portfolio661 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% CRM Ingredient Betamethasone Dipropionate
📗 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.

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

Inactive ingredient FAQ

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

💲 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 · Q2 2026 $0.7627 $34.32 / 45 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Betamethasone Dipropionate .5 mg/g 45802-0376-32 Padagis 1 tube $0.118 AB Availability likely
Betamethasone Dipropionate .5 mg/g 68462-0290-17 Glenmark 15 g $0.200 FDA listed
Betamethasone Dipropionate .5 mg/g 51672-1310-01 Sun 1 tube $0.213 AB Availability likely
Betamethasone Dipropionate .5 mg/g 45802-0021-46 Padagis 56.2 g $0.296 AB Availability likely
Betamethasone Dipropionate .5 mg/g 00168-0055-15 E. 1 tube $0.481 AB Availability likely
Betamethasone Dipropionate .5 mg/g 00472-0380-15 Actavis 1 tube $0.481 AB Availability likely
Betamethasone Dipropionate .5 mg/g 00713-0659-15 Cosette 1 tube $0.481 AB Availability likely
Betamethasone dipropionate .5 mg/g 16714-0996-01 Northstar 1 tube $0.481 AB Availability likely
Betamethasone Dipropionate .5 mg/g 51672-1274-01 Sun 1 tube $0.481 AB Availability likely
Betamethasone dipropionate .5 mg/g 70710-1233-01 Zydus 1 tube $0.481 AB Availability likely
Betamethasone Dipropionate .5 mg/g 00472-0381-15 Actavis 1 tube $0.495 AB Availability likely
betamethasone dipropionate .5 mg/g 72578-0093-01 Viona 1 tube $0.495 AB Availability likely
Betamethasone Dipropionate .5 mg/g 00168-0056-15 E. 1 tube $0.495 AB Discontinued
Betamethasone Dipropionate .5 mg/g 45802-0505-14 Padagis 1 tube $0.495 AB Availability likely
Betamethasone Dipropionate .5 mg/g 00472-0382-15 Actavis 1 tube $0.578 AB Discontinued
Betamethasone Dipropionate .5 mg/g 35573-0107-15 Burel 1 tube $0.578 AB Availability likely
Betamethasone dipropionate .5 mg/g 68180-0947-01 Lupin 1 tube $0.578 AB Availability likely
Betamethasone Dipropionate .5 mg/g 00168-0268-15 E. 15 g $0.578 AB Availability likely
Betamethasone Dipropionate .5 mg/g 66993-0897-15 Prasco 1 tube $0.578 AB Availability likely
Betamethasone Dipropionate .5 mg/g 51672-1309-01 Sun 1 tube $2.632 AB Availability likely
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 50090-3276-00 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 50090-7525-00 A-S 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/gthis 51407-0273-45 Golden 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 59651-0891-14 Aurobindo 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 70518-4187-00 REMEDYREPACK 1 tube AB FDA listed
Betamethasone dipropionate .5 mg/g 70771-1380-01 Zydus 1 tube AB FDA listed
betamethasone dipropionate .5 mg/g 70771-1550-01 Zydus 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 71205-0275-15 Proficient 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 50090-0236-00 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
Diprolene .5 mg/g 78206-0124-01 Organon 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 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 76420-0858-15 Asclemed 1 tube AB FDA listed
Betamethasone Dipropionate .5 mg/g 63629-9324-01 Bryant 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 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 63629-9323-01 Bryant 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

🏛️
1992
On the market since
Apr 1992
📍
2026
Currently FDA-listed
34 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 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 Marketing startStatus
51407-0273-15 1 TUBE in 1 CARTON (51407-273-15) / 15 g in 1 TUBE 2019-10-03 Active
51407-0273-45 You're viewing this 1 TUBE in 1 CARTON (51407-273-45) / 45 g in 1 TUBE 2019-10-03 Active

Pack size FAQ

What quantity is in NDC 51407-0273-45?
NDC 51407-0273-45 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 Cream?
Bill NDC 51407-0273-45 — the 11-digit billing format is 51407027345. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — 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 FDA registers it as 51407-273-45, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51407-0273-45, written without dashes as 51407027345. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51407-0273-45, the first segment (51407) is the labeler code FDA assigned to Golden State Medical Supply, Inc.; the middle segment (0273) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Golden State Medical Supply, 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 (51407-0273-15). 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?
Golden State Medical Supply, 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.

📄 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 29 words

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

⏱️ Dosage and Administration 40 words

DOSAGE AND ADMINISTRATION Apply a thin film of betamethasone dipropionate cream USP, 0.05% to the affected skin areas once daily. In some cases, twice-daily dosage may be necessary. Betamethasone dipropionate cream USP, 0.05% should not be used with occlusive dressings.

Contraindications 24 words

CONTRAINDICATIONS Betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

🤒 Adverse Reactions 130 words

ADVERSE REACTIONS The following local adverse reactions are reported infrequently when betamethasone dipropionate cream USP, 0.05% 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 infections, skin atrophy, striae and miliaria. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream during a pedatric clinical study include signs of skin atrophy (brusing, shininess).

Skin atrophy occurred in 3 of 63 (5%) patients, a 3-year old, a 5-year old, and a 7-year old. 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.

🤰 Pregnancy 138 words

Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 0.03 fold the estimated maximum human dose based on a mg/m 2 comparison.

The abnormalities observed included umbilical hernias, cephalocele and cleft palates. 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 on teratogenic effects from topically applied corticosteroids.

Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

🧒 Pediatric Use ~1 min read

Pediatric Use Use of betamethasone dipropionate cream, 0.05%, in pediatric patients 12 years of age and younger is not recommended. (See CLINICAL PHARMACOLOGY and ADVERSE REACTIONS .) In an open-label study, 10 of 43 (23%) evaluable pediatric patients (aged 2 years to 12 years old) using betamethasone dipropionate cream for treatment of atopic dermatitis for 2 to 3 weeks demonstrated HPA axis suppression. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group.

(See CLINICAL PHARMACOLOGY - Pharmacokinetics .) Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. The study described above supports this premise, as suppression in 9 to 12 year olds, and 2 to 5 year olds was 14%, 23%, and 30%, respectively. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids.

Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen.

Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

🆘 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 through 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. Sixty-three pediatric patients ages 1 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal (HPA) axis safety study.

Betamethasone dipropionate cream was applied twice daily for 2 to 3 weeks over a mean body surface area of 40% (range 35% to 90%). In 10 of 43 (23%) evaluable patients, adrenal suppression was indicated by either a ≤ 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤ 18 mcg/dL and/or an increase of < 7 mcg/dL from the baseline cortisol. Studies performed with betamethasone dipropionate cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 33 words

HOW SUPPLIED Betamethasone Dipropionate Cream USP, 0.05% is supplied in 15 gram (NDC 51407-273-15) and 45 gram (NDC 51407-273-45) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 13 words

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 120 words

DESCRIPTION Betamethasone Dipropionate Cream USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is: Each gram of Betamethasone Dipropionate Cream USP, 0.05% contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a hydrophilic emollient cream consisting of cetomacrogol 1000, cetostearyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum, chlorocresol as preservative, and phosphoric acid and/or sodium hydroxide for pH adjustment.

Chemical Structure

💬 Information for Patients 131 words

Information for Patients This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician.

It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.

The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive. (See DOSAGE AND ADMINISTRATION .) Patients should report any signs of local adverse reactions. Other corticosteroid-containing products should not be used with betamethasone dipropionate cream without first talking to your 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.