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Betamethasone Dipropionate .5 mg/g Cream — NDC 50090-3276-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Betamethasone Dipropionate .5 mg/g Cream — NDC 50090-3276-0 (Billing 50090-3276-00)

by A-S Medication Solutions · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Betamethasone Dipropionate .5 mg/g Cream from A-S Medication Solutions, marketed since Apr 1992 and currently FDA-listed. It is this product's only package size.

NDC 50090-3276-00
🏷️ FDA NDC (as labeled) 50090-3276-0 billing pads the package segment with a zero
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) 50090-3276-0
Product NDC 50090-3276
11-digit billing NDC 50090327600
NCPDP billing unit GM — per gram (weight)
RxCUI 238920
UNII 826Y60901U
Application # ANDA073552
SPL Set ID 5137f94e-6818-440b-a33e-228aa27de61d
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
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 007568
  • GCN: 31060
  • GPI-14 (Medi-Span): 90550020003705
  • HICL (First Databank): 003304
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 238920
Why two NDCs? The FDA registers this code as 50090-3276-0 — a 5-4-1 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 package segment → 50090-3276-00. 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.

Clinical

Label name BETAMETHASONE DP 0.05% CRM 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
  • It calms inflammation and itching from steroid-responsive skin conditions. The spray is specifically for mild to moderate plaque psoriasis in adults. The valerate foam is for the s...
  • Use a thin film or a few drops, as your product directs, once or twice a day. The spray is shaken first and used twice daily. Wash your hands afterward and keep it out of your eyes...
  • Not for long. Several products limit use to about 2 weeks and the spray to 4 weeks. Stop when your skin is under control, and call your doctor if you see no improvement within 2 we...
  • Mild burning, stinging, itching or dryness where you apply it is the most common. Skin thinning can happen with ongoing use. Call me or your doctor if you notice vision changes or...
📖 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.

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 $11.44 / 15 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
50090-3276-00 You're viewing this Main listing 1 TUBE in 1 CARTON / 15 g in 1 TUBE 2017-11-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Betamethasone Dipropionate .5 mg/g 45802-0376-32 Padagis 1 tube $0.124 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 $0.209 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 45802-0021-46 Padagis 56.2 g $0.292 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 00472-0381-15 Actavis 1 tube $0.460 AB Availability likely —
betamethasone dipropionate .5 mg/g 72578-0093-01 Viona 1 tube $0.460 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 00168-0056-15 E. 1 tube $0.460 AB Discontinued —
Betamethasone Dipropionate .5 mg/g 45802-0505-14 Padagis 1 tube $0.460 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 00168-0055-15 E. 1 tube $0.465 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 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 —
Betamethasone Dipropionate .5 mg/g 00472-0382-15 Actavis 1 tube $0.588 AB Discontinued —
Betamethasone Dipropionate .5 mg/g 35573-0107-15 Burel 1 tube $0.588 AB Availability likely —
Betamethasone dipropionate .5 mg/g 68180-0947-01 Lupin 1 tube $0.588 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 00168-0268-15 E. 15 g $0.588 AB Availability likely —
Betamethasone Dipropionate .5 mg/g 51672-1309-01 Sun 1 tube $2.740 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/gthis 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

🏛️
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.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 36W53O7109
    Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
  • 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.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 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

LabelerA-S Medication Solutions
Application holderSUN PHARMA CANADA INC
FDA applicationANDA073552 (ANDA)
Labeler code50090
First marketedApr 1992
Product typeHuman Prescription Drug
Portfolio2,811 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 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 16 words ▾

HOW SUPPLIED Product: 50090-3276 NDC: 50090-3276-0 15 g in a TUBE / 1 in a CARTON

📦 Storage and Handling 33 words ▾

Storage Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

📋 Description 132 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: Molecular formula C 28 H 37 FO 7 Molecular weight of 504.6 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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General 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. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteriod-containing product at the same time may increase total systemic glucocorticoid exposure.

(See DOSAGE AND ADMINISTRATION .) Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

In an open-label pediatric study of 43 evaluable patients, of the 10 subjects who showed evidence of suppression, 2 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream, 0.05%, and 1 of the 2 (50%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS - Pediatric Use ).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

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.

Laboratory Tests The following tests may be helpful in evaluating HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli) , and in the mammalian cell mutagenicity assay (CHO/HGPRT). It as positive in the in-vitro human lymphocyte chromosome aberration assay, and equivocal in the in-vivo mouse bone marrow micronucleus assay.

This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 0.5 and 4 fold the estimated maximum human dose based on a mg/m 2 comparison, respectively.

Pregnancy Category C Cor… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 58 words ▾

Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are prescribed for a nursing woman.

🧬 Pharmacokinetics ~1 min read ▾

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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 141 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli) , and in the mammalian cell mutagenicity assay (CHO/HGPRT). It as positive in the in-vitro human lymphocyte chromosome aberration assay, and equivocal in the in-vivo mouse bone marrow micronucleus assay.

This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 0.5 and 4 fold the estimated maximum human dose based on a mg/m 2 comparison, respectively.

📄 Package Label / Principal Display Panel 4 words ▾

Betamethasone Dipropionate Label Image

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 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.

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 ✓ Available
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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions 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.
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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.