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Sernivo betamethasone dipropionate .5 mg/g Spray — NDC 68040-0714-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sernivo betamethasone dipropionate .5 mg/g Spray — NDC 68040-714-28 (Billing 68040-0714-28)

by Primus Pharmaceuticals, Inc. · 1 BOTTLE, SPRAY in 1 CARTON / 120 g in 1 BOTTLE, SPRAY

This is a package of Sernivo betamethasone dipropionate .5 mg/g Spray from Primus Pharmaceuticals, Inc., marketed since Jun 2021 and currently FDA-listed, this package's marketing is listed to end Apr 2028.

NDC 68040-0714-28
🏷️ FDA NDC (as labeled) 68040-714-28 billing pads the product segment with a zero
This package
Contains120 g in 1 bottle, spray Pack sizes2 compare ↓
Product page 68040-0714-08 Also comes in: 10 g 68040-714-08
Rx only Brand 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

NDC database record

One package, one record: these facts belong to NDC 68040-714-28 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68040 labeler · 714 product · 28 package
Package marketed since
Jun 28, 2021
Package marketing ended
Apr 30, 2028
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6804071428 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68040-714-28
Product NDC 68040-714
11-digit billing NDC 68040071428
NCPDP billing unit ML — per mL (volume)
RxCUI 1738536, 1738541
UNII 826Y60901U
Application # NDA208079
SPL Set ID b1b3d1b0-da9b-11eb-ad76-0800200c9a66
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-28
Route TOPICAL
Dosage form SPRAY
Substance BETAMETHASONE DIPROPIONATE

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

GPI-14 90550020001620
GPI class Sernivo
GCN Seq No 075550
GCN 40655
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 SERNIVO 0.05% SPRAY
FDB brand name Sernivo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075550
  • GCN: 40655
  • GPI-14 (Medi-Span): 90550020001620
  • HICL (First Databank): 003304
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 1738536
Why two NDCs? The FDA registers this code as 68040-714-28 — 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 → 68040-0714-28. 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 SERNIVO 0.05% SPRAY 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 in skin conditions that respond to steroids. The ointment is for people 13 and older. Sernivo spray is used for plaque psoriasis.
  • Use it only on your skin, as directed. With the lotion, a few drops once or twice daily is rubbed in gently. Wash your hands afterward and keep it out of your eyes.
  • Stop once your skin is under control. The strong lotion is limited to 2 weeks. If you see no improvement in 2 weeks, check back with your doctor.
  • Burning, stinging, itching or pain where you apply it are the most common. Skin thinning can also happen. Call your doctor about vision changes or skin that gets worse.
📖 Read our full Betamethasone Topical 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 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 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
68040-0714-28 You're viewing this 1 BOTTLE, SPRAY in 1 CARTON / 120 g in 1 BOTTLE, SPRAY 2021-06-28 Apr 30, 2028 Active
68040-0714-08 68040-714-08 Main listing 1 BOTTLE, SPRAY in 1 CARTON / 10 g in 1 BOTTLE, SPRAY 2021-06-28 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, spray in 1 carton / 120 g in 1 bottle, spray.
What NDC number is used to bill for this package of Sernivo betamethasone dipropionate .5 mg/g Spray?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Betamethasone dipropionate .5 mg/g 51672-1390-04 Sun 1 bottle — — FDA listed —
Sernivo .5 mg/gthis 68040-0714-28 Primus 1 bottle — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2016
First FDA approval
Feb 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2045
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2045. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 5, 2016 RLD RS ⏳ ~19.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9775851 — method of use (U-1858)
US 9364485 — method of use (U-1858)
US 9655907 — method of use (U-1858)
US 10179137 — method of use (U-1858)
US 9433630 — method of use (U-1858)
US 9877974 — method of use (U-1858)
US 9439911 — method of use (U-1858)
US 12661489 — method of use (U-4596)
2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042 2044 2046
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (8)
PatentTypeUse codeExpires
US 9775851 ↗ Method of use U-1858 Aug 31, 2030
US 9364485 ↗ Method of use U-1858 Aug 31, 2030
US 9655907 ↗ Method of use U-1858 Aug 31, 2030
US 10179137 ↗ Method of use U-1858 Aug 31, 2030
US 9433630 ↗ Method of use U-1858 Aug 31, 2030
US 9877974 ↗ Method of use U-1858 Aug 31, 2030
US 9439911 ↗ Method of use U-1858 Aug 31, 2030
US 12661489 ↗ Method of use U-4596 Nov 19, 2045
Common questions
Is there a generic version of SERNIVO 0.05% SPRAY?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for SERNIVO 0.05% SPRAY. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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
ShapeFreeform
ScoringNot scored
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.

🧪 Avoiding an ingredient? See Betamethasone Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • 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 T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 172F2WN8DV
    A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • 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

LabelerPrimus Pharmaceuticals, Inc.
Application holderPRIMUS PHARMACEUTICALS INC
FDA applicationNDA208079 (NDA)
Labeler code68040
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Primus Pharmaceuticals, Inc. labeler code 68040

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. 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 51 words ▾

1 INDICATIONS AND USAGE SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. SERNIVO Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. ( 1 )

⏱️ Dosage and Administration 190 words ▾

2 DOSAGE AND ADMINISTRATION Shake well before use. Apply SERNIVO Spray to the affected skin areas twice daily and rub in gently. Use SERNIVO Spray for up to 4 weeks of treatment.

Treatment beyond 4 weeks is not recommended. Discontinue SERNIVO Spray when control is achieved. Do not use if atrophy is present at the treatment site.

Do not bandage, cover, or wrap the treated skin area unless directed by a physician. Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. SERNIVO Spray is for topical use only.

It is not for oral, ophthalmic, or intravaginal use. Apply to the affected skin areas twice daily. Rub in gently.

( 2 ) Use SERNIVO Spray for up to 4 weeks and not beyond. ( 2 ) Discontinue treatment when control is achieved. ( 2 ) Do not use if atrophy is present at the treatment site.

( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. ( 2 ) Not for oral, ophthalmic, or intravaginal use.

( 2 )

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS Spray, 0.05% for topical use. Each gram of SERNIVO Spray contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white oil-in-water emulsion. Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS SERNIVO Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and use in pediatric patients may predispose to HPA axis suppression. Use of topical corticosteroids may require periodic evaluation for HPA axis suppression.

Modify use if HPA axis suppression develops. ( 5.1 ) High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose to HPA axis suppression. ( 5.1 ) Topical corticosteroids may increase the risk of cataracts and glaucoma.

If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 )

5.1Effects on Endocrine System SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, 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 study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with SERNIVO Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with SERNIVO Spray twice daily for 29 days [ see Clinical Pharmacology ( 12.2 ) ].

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria.

These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended [ see Dosage and Administration ( 2 ) ]. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios.

Use of SERNIVO Spray is not recommended in pediatric patients [ see Use in Specific Populations ( 8.4 ) ].

5.2Ophthalmic Adverse Reactions Use of topical corticosteroids, including SERNIVO Spray, 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 [ see Adverse Reactions ( 6.2 ) ]. Avoid contact of SERNIVO Spray 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. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (≥1%) are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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 two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied SERNIVO Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied SERNIVO Spray and 180 subjects applied vehicle spray.

Adverse reactions that occurred in at least 1% of subjects treated with SERNIVO Spray for up to 28 days are presented in Table 1 . Table 1: Adverse Reactions Occurring in ≥1% of Subjects Treated with SERNIVO Spray for up to Four Weeks SERNIVO Spray b.i.d. (N=352) Vehicle Spray b.i.d.

(N=180) Application site pruritus 6.0% 9.4% Application site burning and/or stinging 4.5% 10.0% Application site pain 2.3% 3.9% Application site atrophy 1.1% 1.7% Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with SERNIVO Spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.

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 have also included striae, 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, and increased intraocular pressure 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 There are no available data on SERNIVO Spray use in pregnant women to evaluate 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 SERNIVO Spray may increase the risk of having a low birthweight infant and to use SERNIVO Spray 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 during the period of organogenesis ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of SERNIVO Spray. The estimated 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 Administration of 0.05 mg/kg betamethasone dipropionate intramuscularly to pregnant rabbits during the period of organogenesis caused malformations.

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 SERNIVO Spray 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 developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SERNIVO Spray and any potential adverse effects on the breastfed infant from SERNIVO Spray or from the underlying maternal condition.

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

8.4Pediatric Use Safety and effectiveness of SERNIVO Spray in patients younger than 18 years of age have not been studied, therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [ see Warnings and Precautions ( 5.1 )] 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.

8.5Geriatric Use Clinical studies of SERNIVO Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy There are no available data on SERNIVO Spray use in pregnant women to evaluate 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 SERNIVO Spray may increase the risk of having a low birthweight infant and to use SERNIVO Spray 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 during the period of organogenesis ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of SERNIVO Spray. The estimated 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 Administration of 0.05 mg/kg betamethasone dipropionate intramuscularly to pregnant rabbits during the period of organogenesis caused malformations.

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

🧒 Pediatric Use 123 words ▾

8.4Pediatric Use Safety and effectiveness of SERNIVO Spray in patients younger than 18 years of age have not been studied, therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [ see Warnings and Precautions ( 5.1 )] 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.

🧓 Geriatric Use 32 words ▾

8.5Geriatric Use Clinical studies of SERNIVO Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~2 min read ▾

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 SERNIVO Spray in psoriasis is unknown.

12.2Pharmacodynamics Vasoconstrictor studies performed with SERNIVO Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. The potential for HPA axis suppression by SERNIVO Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. SERNIVO Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively.

Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with SERNIVO Spray for 15 days. No subjects (0 out of 24) treated with SERNIVO Spray for 29 days had HPA axis suppression.

In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

12.3Pharmacokinetics 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. Topical corticosteroids are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of betamethasone dipropionate, betamethasone-17-propionate, and betamethasone were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [ see Clinical Pharmacology ( 12.2 ) ]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of betamethasone dipropionate, while the metabolites, betamethasone-17-propionate and betamethasone, were detected in the majority of subjects ( Table 2 ). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Table 2: Mean (±SD) Maximum Plasma Concentrations (pg/mL) of Betamethasone Dipropionate Metabolites after 15 or 29 Days of Treatment with SERNIVO Spray Analyte (pg/mL) SERNIVO Spray b.i.d. (15 days) SERNIVO Spray b.i.d. (29 days) Betamethasone-17-propionate 120 ± 127 63.9 ±

52.6Betamethasone 119 ± 176 57.6 ± 55.9

🧬 Mechanism of Action 173 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 SERNIVO Spray in psoriasis is unknown.

16.1How Supplied/Storage SERNIVO Spray is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes: 120 mL (NDC 68040-714-28) Store at controlled room temperature of 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 ]. Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

16.2Handling/Instructions for the Pharmacist Remove the spray pump from the wrapper. Remove and discard the cap from the bottle. Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly. Dispense the bottle with the spray pump inserted. Include the date dispensed in the space provided on the carton.

📦 How Supplied / Storage and Handling 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied/Storage SERNIVO Spray is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes: 120 mL (NDC 68040-714-28) Store at controlled room temperature of 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 ]. Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.

16.2Handling/Instructions for the Pharmacist Remove the spray pump from the wrapper. Remove and discard the cap from the bottle. Keeping the bottle upright, insert the spray pump into the bottle and turn clockwise until it is closed tightly. Dispense the bottle with the spray pump inserted. Include the date dispensed in the space provided on the carton.

📋 Description 125 words ▾

11 DESCRIPTION SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C 28 H 37 FO 7 and the molecular weight is 504.6.

The structural formula is shown below. Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.

Chemical Structure

💬 Information for Patients 182 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients of the following: Discontinue therapy when control is achieved, unless directed otherwise by the physician. Do not use for longer than 4 consecutive weeks.

Avoid contact with the eyes. Avoid use of SERNIVO Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician. Do not occlude the treatment area with bandage or other covering, unless directed by the physician.

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 SERNIVO Spray on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply SERNIVO Spray directly to the nipple and areola to avoid direct infant exposure.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 For Encore Dermatology, Inc. Scottsdale, AZ 85254 Sernivo is a registered trademark of Encore Dermatology, Inc. Revised: 2021-04 Product Insert Item Number SER1325 03/20

🧬 Pharmacokinetics 197 words ▾

12.3Pharmacokinetics 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. Topical corticosteroids are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Plasma concentrations of betamethasone dipropionate, betamethasone-17-propionate, and betamethasone were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [ see Clinical Pharmacology ( 12.2 ) ]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of betamethasone dipropionate, while the metabolites, betamethasone-17-propionate and betamethasone, were detected in the majority of subjects ( Table 2 ). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.

Table 2: Mean (±SD) Maximum Plasma Concentrations (pg/mL) of Betamethasone Dipropionate Metabolites after 15 or 29 Days of Treatment with SERNIVO Spray Analyte (pg/mL) SERNIVO Spray b.i.d. (15 days) SERNIVO Spray b.i.d. (29 days) Betamethasone-17-propionate 120 ± 127 63.9 ±

52.6Betamethasone 119 ± 176 57.6 ± 55.9

🧬 Pharmacodynamics 182 words ▾

12.2Pharmacodynamics Vasoconstrictor studies performed with SERNIVO Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence. The potential for HPA axis suppression by SERNIVO Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. SERNIVO Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively.

Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with SERNIVO Spray for 15 days. No subjects (0 out of 24) treated with SERNIVO Spray for 29 days had HPA axis suppression.

In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.

🔬 Clinical Studies 195 words ▾

14 CLINICAL STUDIES Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied SERNIVO Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).

Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29. Table 3: Proportion of Subjects with Plaque Psoriasis with Treatment Success a after 14 Days and 28 Days of Treatment a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.

Study 1 Study 2 SERNIVO Spray b.i.d. (N=182) Vehicle Spray b.i.d. (N=95) SERNIVO Spray b.i.d.

(N=174) Vehicle Spray b.i.d. (N=87) Treatment Success at Day 15 21.5% 7.4% 19.0% 2.3% Treatment Success at Day 29 42.7% 11.7% 34.5% 13.6%

🧪 Nonclinical Toxicology 210 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. In a 90-day repeat-dose toxicity study in rats, topical administration of betamethasone dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen indicative of severe immune suppression.

A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis. 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 207 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. In a 90-day repeat-dose toxicity study in rats, topical administration of betamethasone dipropionate spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen indicative of severe immune suppression.

A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis. 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 ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 04/2019 PATIENT INFORMATION SERNIVO™ (ser-ne-vo) (betamethasone dipropionate) Spray, 0.05% Important: SERNIVO Spray is for use on the skin only.

Do not get SERNIVO Spray near or in your eyes, mouth, or vagina. What is SERNIVO Spray? SERNIVO Spray is a prescription corticosteroid medicine used to treat mild to moderate plaque psoriasis in people 18 years of age and older.

It is not known if SERNIVO Spray is safe and effective in children under 18 years of age. SERNIVO Spray is not recommended for use in patients under 18 years of age. Before you use SERNIVO Spray, tell your doctor about all of your medical conditions, including if you: are allergic to any of the ingredients in SERNIVO Spray.

See the end of this leaflet for a list of the ingredients in SERNIVO Spray. have thinning of the skin (atrophy) at the treatment site are pregnant or plan to become pregnant. It is not known if SERNIVO Spray will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SERNIVO Spray passes into breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. How should I use SERNIVO Spray?

See the “ Instructions for Use ” for detailed information about the right way to apply SERNIVO Spray. Use SERNIVO Spray exactly as your doctor tells you to use it. Your doctor should tell you how much SERNIVO Spray to use and where to apply it.

Apply SERNIVO Spray 2 times a day. Use SERNIVO Spray for the shortest amount of time needed to treat your plaque psoriasis. Tell your doctor if your skin condition is not getting better after 4 weeks of using SERNIVO Spray.

Do not use SERNIVO Spray for longer than 4 weeks. Wash your hands after applying SERNIVO Spray. Do not use SERNIVO Spray on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together.

Do not bandage, cover, or wrap the treated skin area, unless your doctor tells you to. What are the possible side effects of SERNIVO Spray? SERNIVO Spray can pass through your skin.

Too much SERNIVO Spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems. The most common side effects of SERNIVO Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site.

These are not all the possible side effects of SERNIVO Spray. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SERNIVO Spray? Store SERNIVO Spray at room temperature between 68°F to 77°F (20°C to 25°C). Throw away (discard) any unused SERNIVO Spray after 4 weeks Keep SERNIVO Spray and all medicines out of the reach of children.

General information about the safe and effective use of SERNIVO Spray. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SERNIVO Spray for a condition for which it was not prescribed.

Do not give SERNIVO Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about SERNIVO Spray that is written for health professionals.

What are the ingredients in SERNIVO Spray? Active ingredient: betamethasone dipropionate Inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Distributed by: Encore Dermatology, Inc. Scottsdale, AZ 85254 SER 1288 4/19

📖 Instructions for Use ~1 min read ▾

Instructions for Use SERNIVO™ (ser-ne-vo) (betamethasone dipropionate) Spray, 0.05% Important: SERNIVO Spray is for use on the skin only. Do not get SERNIVO Spray near or in your eyes, mouth, or vagina. Read this “Instructions for Use” before you start using SERNIVO Spray and each time you get a refill.

There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Parts of the SERNIVO Spray bottle.

(See Figure A ) Figure A How to apply SERNIVO Spray: Step 1: Shake the SERNIVO Spray bottle well. Remove the cap from the pump top. Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area.

To spray, push down on the pump top. Apply SERNIVO Spray to the affected area as instructed by your doctor. (See Figure B ) Figure B Step 3: Spray only enough SERNIVO Spray to cover the affected area, for example, the elbow (See Figure C ) .

Rub in SERNIVO Spray gently. Figure C Repeat Steps 2 and 3 to apply SERNIVO Spray to other affected areas as instructed by your doctor. Step 4: After applying SERNIVO Spray, place the cap back onto the pump top.

(See Figure D ) Figure D How should I store SERNIVO Spray? Store SERNIVO Spray at room temperature between 68°F to 77°FF (20°FC to 25°C). Throw away (discard) any unused SERNIVO Spray after 28 days.

Keep SERNIVO Spray and all medicines out of the reach of children. This "Instructions for Use" has been approved by the U.S. Food and Drug Administration.

Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Distributed by: Encore Dermatology, Inc., Scottsdale AZ 85254 SERNIVO is a registered trademark of Encore Dermatology, Inc Issued: 02/2016 Revised: 04/2019 SER1289 4/19 Figure A Figure B Figure C Figure D

📄 Package Label / Principal Display Panel 185 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 68040-714-28 - 120 mL Bottle Label NDC 68040-714-28 120 mL Rx Only Sernivo ® ( beta methasone dipropionate) Spray, 0.05% Potency expressed as betamethasone For Topical Use Only Not for oral, ophthalmic or intravaginal use 120 mL Bottle Label

PRINCIPAL DISPLAY PANEL - NDC: 68040-714-28 - 120 mL Carton Label NDC 68040-714-28 120 mL Rx Only Sernivo ® (betamethasone dipropionate) Spray, 0.05% Potency expressed as betamethasone For Topical Use Only Not for oral, ophthalmic or intravaginal use 120 mL Carton Label

PRINCIPAL DISPLAY PANEL - NDC: 68040-714-08 - 10 mL Sample Bottle Label NDC 68040-714-08 Sample - Not for individual sale 10 mL Rx Only Sernivo ® (betamethasone dipropionate) Spray, 0.05% Potency expressed as betamethasone For Topical Use Only Not for oral, ophthalmic or intravaginal use 10 mL Sample BottleLabel

PRINCIPAL DISPLAY PANEL - NDC: 68040-714-08 - 10 mL Sample Carton Label NDC 68040-714-08 Sample - Not for individual sale 10 mL Rx Only Sernivo ® (betamethasone dipropionate) Spray, 0.05% Potency expressed as betamethasone For Topical Use Only Not for oral, ophthalmic or intravaginal use 10 mL Sample Carton Label

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 (matched by generic name) — 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. CMS lists 2 products for this generic; we show the highest-spend one. 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 Primus Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (68040-0714-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Primus Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68040-0713-38 · Primus 68041-0512-01 · Chemcor →
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.