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Betamethasone Dipropionate .5 mg/mL Lotion, Augmented — NDC 21922-104-21 (Billing 21922-0104-21)

by Encube Ethicals, Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC

This is a package of Betamethasone Dipropionate .5 mg/mL Lotion, Augmented from Encube Ethicals, Inc., marketed since Nov 2025 and currently FDA-listed; retail pharmacies pay about $0.4912 per mL (NADAC).

NDC 21922-0104-21
🏷️ FDA NDC (as labeled) 21922-104-21 billing pads the product segment with a zero
This package
Contains30 mL in 1 bottle, plastic Cost per mL$0.4912 NADAC Per package$14.74 / 30 ml Pack sizes2 compare ↓
Also priced by: Part D plans $0.9636/unit — full pricing hub ↓
Product page 21922-0104-01 Also comes in: 60 mL 21922-104-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 21922-104-21
Product NDC 21922-104
11-digit billing NDC 21922010421
NCPDP billing unit ML — per mL (volume)
RxCUI 848178
UNII 826Y60901U
Application # ANDA206389
SPL Set ID 7e946599-2fb4-4426-bb59-fbb71d89dac8
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 2025-11-25
Route TOPICAL
Dosage form LOTION, AUGMENTED
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 90550020054105
GCN Seq No 014219
GCN 30980
HICL code 003302
Ingredient (HICL) Betamethasone/Propylene Glyc
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 AUG 0.05% LOT
FDB brand name Betamethasone Diprop Augmented
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 014219
  • GCN: 30980
  • GPI-14 (Medi-Span): 90550020054105
  • HICL (First Databank): 003302
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 848178
Why two NDCs? The FDA registers this code as 21922-104-21 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 21922-0104-21. 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 AUG 0.05% LOT Ingredient Betamethasone/Propylene Glyc
📗 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 mLPer package
Retail pharmacies payNADAC · weekly $0.491 $14.74 / 30 ml
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 $0.9636 $28.91 / 30 ml
NADAC price history (per mL) — tap or hover for the price & month
Jun 2026 Jul 2026 Aug 2026 Sep 2026 $0.553 $0.491
▼ Down 11% over the last 4 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
21922-0104-01 21922-104-01 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 60 mL in 1 BOTTLE, PLASTIC $0.5103 / mL $30.62 2025-11-25 — Active
21922-0104-21 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC $0.4912 / mL $14.74 2025-11-25 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.4912 NADAC).

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, plastic in 1 carton / 30 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Betamethasone Dipropionate .5 mg/mL Lotion, Augmented?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Betamethasone Dipropionate .5 mg/mL 00713-0807-53 Cosette 1 bottle $0.292 AB Availability likely save 40%
Betamethasone Dipropionate .5 mg/mL 00168-0057-60 E. 1 bottle $0.292 AB Availability likely save 40%
Betamethasone Dipropionate .5 mg/mL 00168-0267-30 E. 30 ml $0.491 AB Availability likely —
Betamethasone Dipropionate .5 mg/mLthis 21922-0104-21 Encube 1 bottle $0.491 AB Availability likely —
Betamethasone Dipropionate .5 mg/mL 51672-1340-03 Sun 1 bottle $0.491 AB Availability likely —
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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

Manufacturer & labeler

LabelerEncube Ethicals, Inc.
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA206389 (ANDA)
Labeler code21922
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio77 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 62 words ▾

1 INDICATIONS AND USAGE Betamethasone dipropionate lotion (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Betamethasone Dipropionate Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Apply a few drops of betamethasone dipropionate lotion (augmented) to the affected skin areas once or twice daily and massage lightly until the lotion disappears. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Betamethasone dipropionate lotion (augmented) is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate lotion (augmented) should be limited to 2 consecutive weeks and amounts should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [ see WARNINGS AND PRECAUTIONS (5.1) ]. Betamethasone dipropionate lotion (augmented) should not be used with occlusive dressings unless directed by a physician .

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Avoid contact with eyes. Wash hands after each application.

Betamethasone dipropionate lotion (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply a few drops to the affected skin areas once or twice daily and massage lightly until the lotion disappears.

( 2 ) Discontinue therapy when control is achieved. ( 2 ) Limit therapy to no more than 2 consecutive weeks. ( 2 ) Use no more than 50 mL per week.

( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use.

( 2 )

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Lotion, 0.05%. Each gram of betamethasone dipropionate lotion (augmented), 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a colorless, clear to translucent lotion. Lotion, 0.05% ( 3 )

⛔ Contraindications 37 words ▾

4 CONTRAINDICATIONS Betamethasone dipropionate lotion (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Hypersensitivity to any component of this medicine. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Effects on endocrine system: Betamethasone Dipropionate Lotion can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop.

( 5.1 , 8.4 ) Ophthalmic Adverse Reactions. Betamethasone Dipropionate Lotion may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation.

( 5.2 )

5.1Effects on Endocrine System Betamethasone dipropionate lotion (augmented) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of betamethasone dipropionate lotion (augmented) on the HPA axis, betamethasone dipropionate lotion (augmented) was applied once daily at 7 mL per day for 21 days to diseased scalp and body skin in subjects with scalp psoriasis, betamethasone dipropionate lotion (augmented) was shown to lower plasma cortisol levels below normal limits in 2 out of 11 subjects. HPA axis suppression in these subjects was transient and returned to normal within a week.

In one of these subjects, plasma cortisol levels returned to normal while treatment continued. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ] .

5 .2 Ophthalmic Adverse Reactions Use of topical corticosteroids, including betamethasone dipropionate lotion (augmented), may increase the risk of posterior subcapsular cataracts and glaucoma. cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate lotion (augmented) [ see ADVERSE REACTIONS ( 6.2 ) ]. Avoid contact of betamethasone dipropionate lotion (augmented) with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

5.3Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

🤒 Adverse Reactions 192 words ▾

6 AD VERSE REACTIONS

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials, adverse reactions associated with the use of betamethasone dipropionate lotion (augmented) reported at a frequency of less than 1% included erythema, folliculitis, pruritus, and vesiculation.

6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, striae, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported. Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on betamethasone dipropionate lotion (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate lotion (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible.

In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate lotion (augmented) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg.

The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

8.2Lactation Risk Summary There are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production, after topical application of betamethasone dipropionate lotion (augmented) to women who are breastfeeding. It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for betamethasone dipropionate lotion (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate lotion (augmented) or from the underlying maternal condition.

Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use Betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Betamethasone Dipropionate Lotion directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4)].

8.4Pediatric Use Use of betamethasone dipropionate lotion (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [see WARNINGS AND PRECAUTIONS (5.1) ] . In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate lotion (augmented) 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, 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.

Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate lotion (augmented), and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no available data on betamethasone dipropionate lotion (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate lotion (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible.

In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate lotion (augmented) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg.

The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Use of betamethasone dipropionate lotion (augmented) in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [see WARNINGS AND PRECAUTIONS (5.1) ] . In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate lotion (augmented) 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, 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.

Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate lotion (augmented), and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs.

They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids. Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of betamethasone dipropionate lotion (augmented) in the treatment of diaper dermatitis.

🧓 Geriatric Use 95 words ▾

8.5Geriatric Use Clinical trials of betamethasone dipropionate lotion (augmented) included 56 subjects who were 65 years of age and over and 9 subjects who were 75 years of age and over. There was a numerical difference for application site reactions (most frequently reported events were burning and stinging) which occurred in 15% (10/65) of geriatric subjects and 11% (38/342) of subjects less than 65 years of age. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

However, greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology 220 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate lotion (augmented) in corticosteroid responsive dermatoses is unknown.

12.2Pharmacodynamics Vasoconstrictor Assay Trials performed with betamethasone dipropionate lotion USP (augmented) 0.05% indicate that it is in the super-high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3Pharmacokinetics No pharmacokinetic trials have been conducted with betamethasone dipropionate lotion USP (augmented). 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 (2) ]. Topical corticosteroids can be absorbed through normal intact skin.

Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [ see DOSAGE AND ADMINISTRATION (2) ]. Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids.

Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

🧬 Mechanism of Action 34 words ▾

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate lotion (augmented) in corticosteroid responsive dermatoses is unknown.

📦 How Supplied / Storage and Handling 60 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Betamethasone dipropionate lotion, USP (augmented) 0.05% is a colorless, clear to translucent lotion supplied in the following bottle sizes: 30-mL plastic bottle (29 grams) (NDC 21922-104-21) 60-mL plastic bottle (58 grams) (NDC 21922-104-01) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 149 words ▾

11 DESCRIPTION Betamethasone dipropionate lotion (augmented) contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11β, 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: It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. Each gram of betamethasone dipropionate lotion (augmented) 0.05% contains 0.64 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a colorless, clear to translucent lotion base of hydroxypropyl cellulose; isopropyl alcohol (30%); phosphoric acid used to adjust the pH; propylene glycol; purified water; and sodium phosphate monobasic anhydrous. structural formula

💬 Information for Patients 210 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA approved patient labeling (Patient Information) Inform patients of the following: Discontinue therapy when control is achieved, unless directed otherwise by the physician. Use no more than 50 mL per week of betamethasone dipropionate lotion (augmented) and no longer than 2 consecutive weeks. Avoid contact with the eyes.

Advise patients to report any visual symptoms to their healthcare providers. Avoid use of betamethasone dipropionate lotion (augmented) on the face, underarms, or groin areas unless directed by the physician. Do not occlude the treatment area with bandage or other covering, unless directed by the physician.

Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Advise a woman to use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate lotion (augmented) directly to the nipple and areola to avoid direct infant exposure.

Manufactured by: Encube Ethicals Pvt. Ltd. Plot No.

C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Revised: 03/2025

🍼 Nursing Mothers 163 words ▾

8.2Lactation Risk Summary There are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production, after topical application of betamethasone dipropionate lotion (augmented) to women who are breastfeeding. It is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for betamethasone dipropionate lotion (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate lotion (augmented) or from the underlying maternal condition.

Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use Betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Betamethasone Dipropionate Lotion directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4)].

🧬 Pharmacokinetics 136 words ▾

12.3Pharmacokinetics No pharmacokinetic trials have been conducted with betamethasone dipropionate lotion USP (augmented). 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 (2) ]. Topical corticosteroids can be absorbed through normal intact skin.

Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [ see DOSAGE AND ADMINISTRATION (2) ]. Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids.

Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

🧬 Pharmacodynamics 47 words ▾

12.2Pharmacodynamics Vasoconstrictor Assay Trials performed with betamethasone dipropionate lotion USP (augmented) 0.05% indicate that it is in the super-high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

🔬 Clinical Studies 86 words ▾

14 CLINICAL STUDIES The safety and efficacy of betamethasone dipropionate lotion (augmented) for the treatment of corticosteroid-responsive dermatoses have been evaluated in two randomized vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 263 subjects, of whom 131 received betamethasone dipropionate lotion (augmented), were included in these trials. These trials evaluated betamethasone dipropionate lotion (augmented) applied once daily for 21 days.

Betamethasone dipropionate lotion (augmented) was shown to be effective in relieving the signs and symptoms of corticosteroid responsive dermatoses.

🧪 Nonclinical Toxicology 98 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, 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 was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 95 words ▾

13.1Carcinogenesis, Mutagenesis, 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 was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Patient Information Betamethasone Dipropionate (bā′tə-mĕth′ə-sōn′ dī′prō′pē-ə-nāt′) (augmented betamethasone dipropionate) Lotion (Augmented) Important information: Betamethasone Dipropionate Lotion (Augmented) is for use on skin only. Do not use betamethasone dipropionate lotion (Augmented) in your eyes, mouth, or vagina. What is Betamethasone Dipropionate Lotion (Augmented)?

Betamethasone dipropionate lotion (Augmented) is a prescription corticosteroid medicine used on the skin (topical) for the relief of redness, swelling, heat, pain (inflammation) and itching, caused by certain skin problems in people 13 years of age and older. • Betamethasone dipropionate lotion (Augmented) should not be used in children under 13 years of age. Do not use Betamethasone Dipropionate Lotion (Augmented) if you are allergic to betamethasone dipropionate or any of the ingredients in betamethasone dipropionate lotion (Augmented).

See the end of this leaflet for a complete list of ingredients in betamethasone dipropionate lotion (Augmented). Before using Betamethasone Dipropionate Lotion (Augmented), tell your healthcare provider about all of your medical conditions, including if you: • have had irritation or other skin reaction to a steroid medicine in the past. • have thinning of the skin (atrophy) at the treatment site. • have diabetes. • have adrenal gland problems. • have liver problems. • have cataracts or glaucoma. • are pregnant or plan to become pregnant It is not known if betamethasone dipropionate lotion (Augmented) will harm your unborn baby.

If you use betamethasone dipropionate lotion (Augmented) during pregnancy, use betamethasone dipropionate lotion (Augmented) on the smallest area of the skin and for the shortest time needed. • are breastfeeding or plan to breastfeed. It is not known if betamethasone dipropionate lotion (Augmented) passes into your breast milk. Breastfeeding women should use betamethasone dipropionate lotion (Augmented) on the smallest area of skin and for the shortest time needed while breastfeeding.

Do not apply betamethasone dipropionate lotion (Augmented) directly to the nipple and areola to avoid contact with your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or injection or use other products on your skin or scalp that contain corticosteroids.

Do not use other products containing a steroid medicine with betamethasone dipropionate lotion (Augmented) without talking to your healthcare provider first. How should I use Betamethasone Dipropionate Lotion (Augmented)? Use Betamethasone Dipropionate Lotion exactly as your healthcare provider tells you to use it.

Apply a thin layer (film) of betamethasone dipropionate lotion (augmented) to the affected skin area 1 or 2 times each day. Do not use more than 50 mL of betamethasone dipropionate lotion (augmented) in 1 week. Do not use betamethasone dipropionate lotion (augmented) for longer than 2 weeks in a row unless your healthcare provider tells you to.

Tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment with betamethasone dipropionate lotion (augmented). Do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. Betamethasone dipropionate lotion (augmented) should not be used to treat diaper rash or redness.

Avoid using betamethasone dipropionate lotion (augmented) on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site. Wash your hands after applying betamethasone dipropionate lotion (augmented) unless you are using the medicine to treat your hands. What are the possible side effects of Betamethasone Dipropionate Lotion (Augmented)?

Betamethasone dipropionate lotion (augmented) may cause serious si… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 10 words ▾

Warnings and Precautions, Ophthalmic Adverse Reactions ( 5.2 ) 05/2019

📄 Package Label / Principal Display Panel 97 words ▾

PRINCIPAL DISPLAY PANEL NDC 21922- 104 -21 Betamethasone Dipropionate Lotion USP, 0.05% (Augmented)* For Topical Use Only. Not for oral, ophthalmic, or intravaginal use. (Potency expressed as betamethasone) *Vehicle augments the penetration of the steroid.

DO NOT USE IN EYES 30 mL (29 g) Rx only . NDC 21922- 104 -01 Betamethasone Dipropionate Lotion USP, 0.05% (Augmented)* For Topical Use Only. Not for oral, ophthalmic, or intravaginal use.

(Potency expressed as betamethasone) *Vehicle augments the penetration of the steroid. DO NOT USE IN EYES 60 mL (58 g) Rx only . Carton 30 ml Carton 60 ml

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.
← 21922-0101-04 · Encube 21922-0105-52 · Encube →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.