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Betamethasone Dipropionate .5 mg/g Cream — NDC 00472-0380-15 package photo

Betamethasone Dipropionate .5 mg/g Cream

by Actavis Pharma, Inc. · 1 TUBE in 1 CARTON (0472-0380-15) / 15 g in 1 TUBE
NDC 00472-0380-15
🏷️ FDA NDC (as labeled) 0472-0380-15 billing pads the labeler segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.4646 NADAC Per package$6.97 / 15 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.8864/unit · Part D plans $0.7627/unit — full pricing hub ↓
Also comes in: 45 g 00472-0380-45
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 0472-0380-15
Product NDC 0472-0380
11-digit billing NDC 00472038015
NCPDP billing unit GM — per gram (weight)
RxCUI 238920
UNII 826Y60901U
UPC 0304720380153
Application # ANDA070885
SPL Set ID ab332791-461b-4396-9b46-7f00bc04c087
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 2002-09-03
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 0472-0380-15 — 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 → 00472-0380-15. 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 applicationANDA070885 (ANDA)
Labeler code00472
First marketedSep 2002
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% 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.

🧪 Full Betamethasone Dipropionate nutrient depletion report →
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 $0.465 $6.97 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.8864 $13.30 / 15 g
Medicare drug plans payPart D · Q2 2026 $0.7627 $11.44 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.023 $0.465
▼ Down 54% 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 73%
Betamethasone Dipropionate .5 mg/g 68462-0290-17 Glenmark 15 g $0.200 — FDA listed save 57%
Betamethasone Dipropionate .5 mg/g 51672-1310-01 Sun 1 tube $0.209 AB Availability likely save 55%
Betamethasone Dipropionate .5 mg/g 45802-0021-46 Padagis 56.2 g $0.292 AB Availability likely save 37%
Betamethasone Dipropionate .5 mg/g 00472-0381-15 Actavis 1 tube $0.460 AB Availability likely save 1%
betamethasone dipropionate .5 mg/g 72578-0093-01 Viona 1 tube $0.460 AB Availability likely save 1%
Betamethasone Dipropionate .5 mg/g 00168-0056-15 E. 1 tube $0.460 AB Discontinued save 1%
Betamethasone Dipropionate .5 mg/g 45802-0505-14 Padagis 1 tube $0.460 AB Availability likely save 1%
Betamethasone Dipropionate .5 mg/g 00168-0055-15 E. 1 tube $0.465 AB Availability likely —
Betamethasone Dipropionate .5 mg/gthis 00472-0380-15 Actavis 1 tube $0.465 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 00713-0659-15 Cosette 1 tube $0.465 AB Availability likely —
Betamethasone dipropionate .5 mg/g 16714-0996-01 Northstar 1 tube $0.465 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 51672-1274-01 Sun 1 tube $0.465 AB Availability likely —
Betamethasone dipropionate .5 mg/g 70710-1233-01 Zydus 1 tube $0.465 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 66993-0897-15 Prasco 1 tube $0.578 AB Availability likely +25%
Betamethasone Dipropionate .5 mg/g 00472-0382-15 Actavis 1 tube $0.588 AB Discontinued +27%
Betamethasone Dipropionate .5 mg/g 35573-0107-15 Burel 1 tube $0.588 AB Availability likely +27%
Betamethasone dipropionate .5 mg/g 68180-0947-01 Lupin 1 tube $0.588 AB Availability likely +27%
Betamethasone Dipropionate .5 mg/g 00168-0268-15 E. 15 g $0.588 AB Availability likely +27%
Betamethasone Dipropionate .5 mg/g 51672-1309-01 Sun 1 tube $2.740 AB Availability likely +490%
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/g 51407-0273-15 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

🏛️
2002
On the market since
Sep 2002
📍
2026
Currently FDA-listed
24 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 00472-0380-15, 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
2.2K
Units reimbursed last 4 qtrs
60.6K
Gross reimbursed last 4 qtrs
$53.7K
Avg / prescription
$24.24
Avg / unit
$0.8864
Latest quarter Q1 2026
468Rx
Medicaid pays / g
$0.8864
gross reimbursed
vs
NADAC / g
$0.4646
acquisition cost
=
Spread
+$0.4218
+91% 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 ⓘ
60% FFS 40% MCO
Fee-for-service · 1,323 Rx Managed care · 892 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 255 units · 4.4 per 100k residents MN Wisconsin: no data reported WI Michigan: 6,660 units · 66.4 per 100k residents MI New York: 12,825 units · 65.5 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: 3,555 units · 27.4 per 100k residents PA New Jersey: 240 units · 2.6 per 100k residents NJ Massachusetts: 510 units · 7.3 per 100k residents MA California: 23,175 units · 59.5 per 100k residents CA Utah: no data reported UT Colorado: 1,755 units · 29.9 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 5,160 units · 114 per 100k residents KY West Virginia: 240 units · 13.6 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 225 units · 3.0 per 100k residents AZ New Mexico: 1,395 units · 66.0 per 100k residents NM Kansas: 600 units · 20.4 per 100k residents 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: 945 units · 32.1 per 100k residents MS Alabama: no data reported AL Georgia: 780 units · 7.1 per 100k residents GA D.C.: no data reported DC Hawaii: 1,230 units · 85.7 per 100k residents HI Texas: 1,035 units · 3.4 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.6114
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 Kentucky 114 /100k
2 Hawaii 85.7 /100k
3 Michigan 66.4 /100k
4 New Mexico 66.0 /100k
5 New York 65.5 /100k
6 California 59.5 /100k
7 Mississippi 32.1 /100k
8 Colorado 29.9 /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 tube00472-0380-45 5,623 Rx · $166,797
1 tube this page00472-0380-15 2,215 Rx · $53,700
Drug total (last 4 qtrs): 7,838 Rx · 324,295 units · $220,497 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
00472-0380-15 You're viewing this 1 TUBE in 1 CARTON (0472-0380-15) / 15 g in 1 TUBE $0.4646 / g $6.97 2002-09-03 Active
00472-0380-45 1 TUBE in 1 CARTON (0472-0380-45) / 45 g in 1 TUBE $0.3711 / g $16.70 2002-09-03 Active

Per g, this pack runs about 25% above the cheapest pack (NDC 00472-0380-45, $0.3711 vs $0.4646 NADAC).

This pack accounts for about 28% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00472-0380-15?
NDC 00472-0380-15 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 Betamethasone Dipropionate .5 mg/g Cream?
Bill NDC 00472-0380-15 — the 11-digit billing format is 00472038015. 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 ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 28 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 41 words ▾

DOSAGE AND ADMINISTRATION Apply a thin film of betamethasone dipropionate cream 0 . 05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary. Betamethasone dipropionate cream is not to 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 142 words ▾

ADVERSE REACTIONS The following local adverse reactions are reported infrequently when betamethasone dipropionate cream 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 cream during a pediatric clinical study include signs of skin atrophy (bruising, 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. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://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. 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 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/or an increase of less than 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 65 words ▾

HOW SUPPLIED Betamethasone Dipropionate Cream, USP, 0 . 05% is available in: 15 gram (0 . 53 oz) NDC 0472-0380-15 45 gram (1 . 59 oz) NDC 0472-0380-45 Store between 15° to 30°C (59° to 86°F). Manufactured In India By: Encube Ethicals Private Limited Plot No. C-1 Madkaim Industrial Estate, Madkaim Ponda, Goa, 403404, India Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 4/2024

📋 Description 142 words ▾

DESCRIPTION Betamethasone dipropionate cream contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineral-ocorticoid 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 cream 0 .

05% contains: 0 . 64 mg betamethasone dipropionate USP (equivalent to 0 . 5 mg betamethasone) in a hydrophilic cream base consisting of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate, propylene glycol, phosphoric acid and/or sodium hydroxide for pH adjustment and chlorocresol as a preservative.

1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00472-0379-15 · Actavis 00472-0381-15 · Actavis →
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.