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QVAR REDIHALER Beclomethasone Dipropionate HFA 40 ug Aerosol, Metered — NDC 50090-3458-0 (Billing 50090-3458-00)

by A-S Medication Solutions · 1 INHALER in 1 CARTON / 1 CANISTER in 1 INHALER / 120 AEROSOL, METERED in 1 CANISTER

This is a package of QVAR REDIHALER Beclomethasone Dipropionate HFA 40 ug Aerosol, Metered from A-S Medication Solutions, marketed since Feb 2018 and currently FDA-listed. It is this product's only package size.

NDC 50090-3458-00
🏷️ FDA NDC (as labeled) 50090-3458-0 billing pads the package segment with a zero
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 50090-3458-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50090 labeler · 3458 product · 0 package
Package marketed since
May 21, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5009034580 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50090-3458-0
Product NDC 50090-3458
11-digit billing NDC 50090345800
NCPDP billing unit GM — per gram (weight)
RxCUI 1998771, 1998772, 1998773, 1998774
UNII 5B307S63B2
Application # NDA207921
SPL Set ID ccd3aaec-4892-40d0-ad60-3e570178fbe1
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 2018-02-15
Route RESPIRATORY (INHALATION)
Dosage form AEROSOL, METERED
Substance BECLOMETHASONE DIPROPIONATE

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

GPI-14 44400010128120
GPI class Qvar RediHaler
Quick answers
  • GPI-14 (Medi-Span): 44400010128120
  • RxCUI (RxNorm): 1998771
Why two NDCs? The FDA registers this code as 50090-3458-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 50090-3458-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, potent (group III), Corticosteroids
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

📗 Our plain-language guide HelloPharmacist
  • It is used every day to keep asthma under control in people 5 and older. It lowers inflammation in the airways. It is not a rescue inhaler, so it will not stop a sudden attack.
  • Prime it with two sprays into the air before first use or if it has gone unused for over 10 days. Take it twice daily, about 12 hours apart, as directed. Rinse your mouth with wate...
  • Inhaled steroids can cause a yeast infection called thrush in the mouth and throat. Rinsing and spitting helps lower that risk. Tell your doctor if you see white patches or have so...
  • Some people feel better within 24 hours. You should notice a difference in the first week or two. Full benefit can take 3 to 4 weeks, so keep using it as prescribed.
📖 Read our full Beclomethasone Oral Inhalation guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $21.93 $2,631.89 / 120 aerosols
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50090-3458-00 You're viewing this Main listing 1 INHALER in 1 CARTON / 1 CANISTER in 1 INHALER / 120 AEROSOL, METERED in 1 CANISTER 2018-05-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Qvar Redihaler 40 ug 59310-0302-40 Teva 1 inhaler $20.566 — Availability likely —
Qvar Redihaler 40 ugthis 50090-3458-00 A-S 1 inhaler — — FDA listed —
Qvar Redihaler 40 ug 50090-5031-00 A-S 1 inhaler — — 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

🏛️
2017
First FDA approval
Aug 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2041
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 Aug 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 3, 2017 RLD RS ⏳ ~14.9 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 11395889 — drug product
US 12296089 — drug product
US 10022510 — drug product
US 11957832 — drug product
US 10695512 — drug product
US 8132712 — drug product
US 10022509 — drug product
US 8931476 — drug product
US 10561808 — drug product
US 10086156 — drug product
US 11793953 — drug product
US 10792447 — drug product
US 11395888 — drug product
US 10022509 — drug product
US 11865247 — drug product
US 11957832 — drug product
US 11395889 — drug product
US 10022510 — drug product
US 10792447 — drug product
US 11896759 — drug product
US 10086156 — drug product
US 10695512 — drug product
US 11559637 — drug product
US 11583643 — drug product
US 11395888 — drug product
US 11559637 — drug product
US 10561808 — drug product
US 11583643 — drug product
US 11793953 — drug product
US 8132712 — drug product
US 8931476 — drug product
US 12296089 — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
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 (32)
PatentTypeUse codeExpires
US 11395889 ↗ delist req. Drug product — May 18, 2031
US 12296089 ↗ Drug product — Jan 26, 2038
US 10022510 ↗ delist req. Drug product — May 18, 2031
US 11957832 ↗ Drug product — May 5, 2041
US 10695512 ↗ delist req. Drug product — May 18, 2031
US 8132712 ↗ delist req. Drug product — Sep 7, 2028
US 10022509 ↗ delist req. Drug product — May 18, 2031
US 8931476 ↗ Drug product — Jul 17, 2031
US 10561808 ↗ delist req. Drug product — Jan 1, 2032
US 10086156 ↗ delist req. Drug product — May 18, 2031
US 11793953 ↗ Drug product — Jan 26, 2038
US 10792447 ↗ Drug product — Jan 25, 2039
US 11395888 ↗ Drug product — Jan 26, 2038
US 10022509 ↗ delist req. Drug product — May 18, 2031
US 11865247 ↗ delist req. Drug product — Jan 26, 2038
US 11957832 ↗ Drug product — May 5, 2041
US 11395889 ↗ delist req. Drug product — May 18, 2031
US 10022510 ↗ delist req. Drug product — May 18, 2031
US 10792447 ↗ Drug product — Jan 25, 2039
US 11896759 ↗ delist req. Drug product — Jan 26, 2038
US 10086156 ↗ delist req. Drug product — May 18, 2031
US 10695512 ↗ delist req. Drug product — May 18, 2031
US 11559637 ↗ Drug product — Jul 21, 2039
US 11583643 ↗ Drug product — Aug 19, 2041
US 11395888 ↗ Drug product — Jan 26, 2038
US 11559637 ↗ Drug product — Jul 21, 2039
US 10561808 ↗ delist req. Drug product — Jan 1, 2032
US 11583643 ↗ Drug product — Aug 19, 2041
US 11793953 ↗ Drug product — Jan 26, 2038
US 8132712 ↗ delist req. Drug product — Sep 7, 2028
US 8931476 ↗ Drug product — Jul 17, 2031
US 12296089 ↗ Drug product — Jan 26, 2038
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. 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.

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

LabelerA-S Medication Solutions
Application holderNORTON WATERFORD LTD
FDA applicationNDA207921 (NDA)
Labeler code50090
First marketedFeb 2018
Product typeHuman Prescription Drug
Portfolio2,811 products on file

More NDCs from A-S Medication Solutions labeler code 50090

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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 85 words ▾

1 INDICATIONS AND USAGE QVAR REDIHALER is indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. Limitations of Use: QVAR REDIHALER is not indicated for the relief of acute bronchospasm. QVAR REDIHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older.

( 1 ) Limitations of Use : Not indicated for the relief of acute bronchospasm. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2.1 ) Starting dosage is based on prior asthma therapy and disease severity. ( 2.2 ) Treatment of asthma in patients 4 to 11 years of age: 40 mcg or 80 mcg twice daily.

( 2.2 ) Treatment of asthma in patients 12 years of age and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily ( 2.2 ) Discard QVAR REDIHALER inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. ( 2.1 ) Do not use a spacer or volume holding chamber ( 2.1 )

2.1General Overview Administration Administer QVAR REDIHALER by oral inhalation. After inhalation, rinse mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. Consistent dose delivery is achieved, whether using the 40‑ or 80‑mcg strengths, due to proportionality of the 2 products (i.e., 2 actuations of 40‑mcg strength should provide a dose comparable to 1 actuation of the 80‑mcg strength).

Inhaler Instructions Patients should be instructed on the proper use of their inhaler. Do not use QVAR REDIHALER with a spacer or volume holding chamber. Shaking the inhaler prior to use is not necessary.

Do not shake the inhaler with the cap open to avoid possible actuation of the device. Priming QVAR REDIHALER does not require priming. Cleaning Keep the inhaler clean and dry at all times.

Never wash or put any part of the inhaler in water. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.

Dose Counter QVAR REDIHALER has a dose counter attached to the actuator. When the patient receives the inhaler, the number 120 will be displayed. The dose counter will count down each time a spray is released.

When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Discard QVAR REDIHALER inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first [see Patient Counseling Information ( 17 )] .

2.2Recommended Dosage Adults and Adolescents 12 years of age and older The recommended starting dosage for patients 12 years of age and older who are not on an inhaled corticosteroid is 40 to 80 mcg twice daily by oral inhalation, approximately 12 hours apart. The starting dosage is based on previous asthma therapy and disease severity, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. For patients switching to QVAR REDIHALER from another inhaled corticosteroid product, select the appropriate starting dosage strength of QVAR REDIHALER based on the strength of the previous inhaled corticosteroid product and disease severity: 40, 80, 160 or 320 mcg twice daily.

For patients who do not respond adequately to the initial dosage after 2 weeks of therapy, increasing the dosage may provide additional asthma control. The maximum recommended dosage for patients 12 years of age and older is 320 mcg twice daily. Pediatric Patients 4 to 11 years The recommended starting dosage for patients aged 4 to 11 years of age is 40 mcg twice daily by oral inhalation, approximately 12 hours apart.

The starting dosage is based on previous asthma therapy and disease severity, including consideration of the patients’ current control of asthma symptoms and risk of future exacerbation. For patients who do not respond adequately to QVAR REDIHALER 40 mcg after 2 weeks of therapy, increasing the dosage to QVAR REDIHALER 80 mcg twice daily may provide additional asthma control. The maximum recommended dosage for patients 4 to 11 years of age is 80 mcg twice daily.

General Dosing Recommendations The onset and degree of symptom relief will vary in individual patients. Improvement in asthma symptoms can occur within 24 hour… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 66 words ▾

3 DOSAGE FORMS AND STRENGTHS Inhalation aerosol: a pressurized, breath‑actuated, metered-dose aerosol with a dose counter in 2 strengths 40 mcg in an aluminum canister contained within a beige plastic actuator and a hinged white cap 80 mcg in an aluminum canister contained within a maroon plastic actuator and a hinged white cap Inhalation aerosol: 40 mcg or 80 mcg per breath actuation. ( 3 )

⛔ Contraindications 87 words ▾

4 CONTRAINDICATIONS QVAR REDIHALER is contraindicated in: the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER [see Warnings and Precautions ( 5.6 )] . Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ( 4 ) Hypersensitivity to any of the ingredients of QVAR REDIHALER.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Oropharyngeal candidiasis: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk.

( 5.1 ) Deterioration of asthma and acute episodes: Do not use QVAR REDIHALER for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids.

Taper patients slowly from systemic corticosteroids if transferring to QVAR REDIHALER. ( 5.3 ) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

Use with caution in patients with these infections because of the potential for worsening of these infections. ( 5.4 ) Paradoxical bronchospasm: Bronchospasm, with an immediate increase in wheezing, may occur after dosing. Treat bronchospasm immediately with inhaled, short-acting bronchodilator and discontinue QVAR REDIHALER.

( 5.5 ) Hypersensitivity reactions: Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm may occur. Discontinue QVAR REDIHALER if such reactions occur. ( 5.6 ) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals.

If such changes occur, discontinue QVAR REDIHALER slowly. ( 5.7 ) Effects on growth: Monitor growth of pediatric patients. ( 5.8 ) Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content.

( 5.9 ) Glaucoma and cataracts: Monitor patients with change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts closely. ( 5.10 )

5.1Oropharyngeal Candidiasis Localized infections with Candida albicans have occurred in the mouth and pharynx in some patients receiving QVAR REDIHALER. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with QVAR REDIHALER therapy, but at times therapy with QVAR REDIHALER may need to be temporarily interrupted under close medical supervision. After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

5.2Deterioration of Asthma and Acute Episodes QVAR REDIHALER is not indicated for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short‑acting beta 2 ‑agonist, not QVAR REDIHALER, should be used to relieve acute symptoms such as shortness of breath. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with QVAR REDIHALER.

During such episodes, patients may require therapy with oral corticosteroids.

5.3Transferring Patients from Systemic Corticosteroid Therapy HPA Suppression/Adrenal Insufficiency Particular care is needed in patients who are transferred from systemically active corticosteroids to QVAR REDIHALER because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic‑pituitary‑adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA sup… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Oropharyngeal candidiasis [see Warnings and Precautions ( 5.1 )] Immunosuppression and risk of infections [see Warnings and Precautions ( 5.4 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.7 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.9 )] Growth effects [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.4 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence > 3% and > placebo) include oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and sinusitis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience A total of 1858 subjects participated in the QVAR REDIHALER clinical development program. 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 practice. Adults and Adolescent Patients 12 years of Age and Older: The adverse reaction information presented in Table 1 is derived from 3 double-blind, placebo-controlled clinical trials in which 1230 patients (751 female and 479 male adults previously treated with as‑needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR REDIHALER (doses of 40, 80, 160, or 320 mcg twice daily) or QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol (QVAR MDI; doses of 160 or 320 mcg twice daily) or placebo.

In considering these data, difference in average duration of exposure and clinical trial design should be taken into account. Table 1: Adverse Reactions Experienced by at Least 3% of Adult and Adolescent Patients in the QVAR REDIHALER or QVAR MDI Groups and Greater Than Placebo by Treatment and Daily Dose Preferred Term Number (%) of patients QVAR REDIHALER QVAR MDI Placebo 80 mcg N=90 160 mcg N=92 320 mcg N=214 640 mcg N=211 320 mcg N=212 640 mcg N=107 N=304 Oral Candidiasis 0 2 (2) 7 (3) 15 (7) 6 (3) 9 (8) 1 (<1) Upper Respiratory Tract Infection 3 (3) 3 (3) 9 (4) 6 (3) 17 (8) 4 (4) 6 (2) Nasopharyngitis 4 (4) 2 (2) 3 (1) 3 (1) 6 (3) 4 (4) 4 (1) Oropharyngeal Pain 2 (2) 2 (2) 1 (<1) 3 (1) 6 (3) 4 (4) 2 (<1) Viral Upper Respiratory Tract Infection 3 (3) 0 1 (<1) 3 (1) 4 (2) 2 (<1) 4 (1) Sinusitis 3 (3) 0 1 (<1) 2 (<1) 1 (<1) 1 (<1) 2 (<1) Rhinitis Allergic 0 3 (3) 0 2 (<1) 0 1 (<1) 0 *QVAR MDI=QVAR Inhalation Aerosol Other adverse reactions that occurred in clinical trials using QVAR REDIHALER with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were back pain, headache, pain, nausea and cough.

Pediatric Patients 4 to 11 Years of Age: The adverse reaction information presented in Table 2 concerning QVAR REDIHALER and QVAR MDI is derived from one 12‑week placebo-controlled study in pediatric patients 4 to 11 years of age with persistent asthma. Table 2: Adverse Reactions Experienced by at Least 3% of Patients 4 to 11 Years of Age in the QVAR REDIHALER or QVAR MDI Groups and Greater Than Placebo by Treatment and Daily Dose Preferred Term Number (%) of patients QVAR REDIHALER QVAR MDI Placebo 80 mcg N=126 160 mcg N=125 80 mcg N=125 160 mcg N=125 N=127 Upper Respiratory Tract Infection 3 (2.4) 1 (0.8) 6 (4.8) 5 (4.0) 5 (3.9) Nasopharyngitis 5 (4.0) 11 (8.8) 6 (4.8) 6 (4.8) 4 (3.1) Viral Upper Respiratory Tract Infection 5 (4.0) 5 (4.0) 3 (2.4) 1 (0.8) 4 (3.1) Pharyngitis 4 (3.2) 4 (3.2) 4 (3.2) 4 (3.2) 2 (1.6) Cough 1 (0.8) 3 (2.4) 9 (7.2) 6 (4.8) 4 (3.1) Vomiting 2 (1.6) 2 (1.6) 4 (3.2) 0 2 (1.6) Headache 2 (1.6) 5 (4.0) 0 4 (3.2) 5 (3.9) Pyrexia 1 (0.8) 4 (3.2) 4 (3.2) 3 (2.4) 3 (2.4) *QVAR MDI=QVAR Inhalation Aerosol Other… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well‑controlled studies with QVAR REDIHALER or beclomethasone dipropionate in pregnant women. There are clinical considerations with the use of inhaled corticosteroids (ICS), including beclomethasone dipropionate, in pregnant women [see Clinical Considerations] . Also, no published studies, including studies of large birth registries, have to date related the use of ICS to any increases in congenital malformations or other adverse perinatal outcomes.

Thus, available human data do not establish the presence or absence of drug‑associated risk to the fetus. In animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.75 times the maximum recommended human daily inhalation dose (MRHDID) in adults (0.64 mg/day) [see Data] . In rats exposed to beclomethasone dipropionate by inhalation, dose‑related gross injury to the fetal adrenal glands was observed at doses greater than 180 times the MRHDID, but there was no evidence of external or skeletal malformations or embryolethality at inhalation doses of up to 440 times the MRHDID.

The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the US general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑4% and 15‑20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk The risk of complications to the mother and developing fetus from inadequate control of asthma must be balanced against the risks from exposure to beclomethasone dipropionate.

In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age for the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted to maintain optimal control. Labor or Delivery There are no specific human data regarding any adverse effects of inhaled beclomethasone dipropionate on labor and delivery.

Data Animal Data In an embryofetal development study in pregnant rats, beclomethasone dipropionate administration during organogenesis from gestation days 6 to 15 at inhaled doses 180 times the MRHDID in adults and higher (on a mg/m 2 basis at maternal doses of 11.5 and 28.3 mg/kg/day) produced dose‑dependent gross injury (characterized by red foci) of the adrenal glands in fetuses. There were no findings in the adrenal glands of rat fetuses at an inhaled dose that was 40 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 2.4 mg/kg/day).

There was no evidence of external or skeletal malformations or embryolethality in rat at inhaled doses up to 440 times the MRHDID (on a mg/m 2 basis at maternal doses up to 28.3 mg/kg/day). In an embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 18 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m 2 basis at maternal doses of 0.1 mg/kg/day and higher) produced adverse developmental effects (increased incidence of cleft palate).

A no-effect dose in mice was not identified. In a second embryofetal development study in pregnant mice, beclomethasone dipropionate administration from gestation days 1 to 13 at subcutaneous doses equal to and greater than 2.3 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 0.3 mg/kg/day) produced embryolethal effects (increased fetal resorptions) and decreased pup survival. In an embryofetal development study in pregnant rabbits, beclomethasone dipropionate administration during organogenesis from gestation days 7 to 16 at subcutaneous doses equal to and greater than 0.75 times the MRHDID in adults (on a mg/m 2 b… [Excerpted — this section continues on DailyMed.]

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Beclomethasone dipropionate is a corticosteroid demonstrating potent anti‑inflammatory activity. The precise mechanism of corticosteroid action on asthma is not known. Corticosteroids have been shown to have multiple anti‑inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines).

These anti‑inflammatory actions of corticosteroids contribute to their efficacy in asthma. Beclomethasone dipropionate is a prodrug that is rapidly activated by hydrolysis to the active monoester, 17‑monopropionate (17‑BMP). Beclomethasone‑17‑monopropionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor which is approximately 13 times that of dexamethasone, 6 times that of triamcinolone acetonide, 1.5 times that of budesonide and 25 times that of beclomethasone dipropionate.

The clinical significance of these findings is unknown. Studies in patients with asthma have shown a favorable ratio between topical anti‑inflammatory activity and systemic corticosteroid effects with recommended doses of QVAR REDIHALER.

12.2Pharmacodynamics HPA Axis Effects The effects of QVAR MDI on the hypothalamic‑pituitary‑adrenal (HPA) axis were studied in 40 corticosteroid-naive patients. QVAR MDI, at doses of 80, 160, or 320 mcg twice daily, was compared with placebo and 336 mcg twice daily of CFC‑BDP. Active treatment groups showed an expected dose‑related reduction in 24‑hour urinary-free cortisol (a sensitive marker of adrenal production of cortisol).

Patients treated with the highest dose recommended of QVAR MDI (320 mcg twice daily) had a 37.3% reduction in 24‑hour urinary‑free cortisol compared to a reduction of 47.3% produced by treatment with 336 mcg twice daily of CFC‑BDP. There was a 12.2% reduction in 24‑hour urinary‑free cortisol seen in the group of patients that received 80 mcg twice daily of QVAR MDI and a 24.6% reduction in the group of patients that received 160 mcg twice daily. An open label study of 354 asthma patients given QVAR MDI at recommended doses for one year assessed the effect of treatment with this product on the HPA axis (as measured by both morning and stimulated plasma cortisol).

Less than 1% of patients treated for one year with this product had an abnormal response (peak less than 18 mcg/dL) to a short-cosyntropin test.

12.3Pharmacokinetics Beclomethasone dipropionate undergoes rapid and extensive conversion to beclomethasone‑17‑monopropionate (17‑BMP) during absorption. The pharmacokinetics of beclomethasone dipropionate and 17‑BMP were studied in subjects given single doses. Absorption The mean peak plasma concentration (C max ) of BDP was 6635 pg/mL at 2 minutes after inhalation of 320 mcg using QVAR REDIHALER (4 inhalations of the 80 mcg/inhalation strength).

The mean peak plasma concentration of the major and most active metabolite, 17-BMP, was 1464 pg/mL at 10 minutes after inhalation of 320 mcg of QVAR REDIHALER. Distribution The in vitro protein binding for 17‑BMP was reported to be 94‑96% over the concentration range of 1000 to 5000 pg/mL. Protein binding was constant over the concentration range evaluated.

There is no evidence of tissue storage of beclomethasone dipropionate or its metabolites. Elimination The major route of elimination of inhaled beclomethasone dipropionate appears to be via hydrolysis. More than 90% of inhaled beclomethasone dipropionate is found as 17‑BMP in the systemic circulation.

The mean terminal half‑life of 17‑BMP is approximately 4 hours for QVAR REDIHALER. Metabolism Three major metabolites are formed via esterases: beclomethasone‑17‑monopropionate (17‑BMP) beclomethasone‑21‑monopropionate (21‑BMP) beclomethasone (BOH) Lung slices metabolize beclomethasone dipropionate rapidly to 17‑BMP and more slowly to BOH. 17‑BMP is the m… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 40 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-3458 NDC: 50090-3458-0 1 AEROSOL, METERED in a CARTON / 120 in a CANISTER / 1 in a INHALER Product: 50090-3459 NDC: 50090-3459-0 120 AEROSOL, METERED in a CANISTER / 1 in a CARTON

📋 Description ~1 min read ▾

11 DESCRIPTION The active component of QVAR REDIHALER 40 mcg Inhalation Aerosol and QVAR REDIHALER 80 mcg Inhalation Aerosol is beclomethasone dipropionate, USP, a corticosteroid having the chemical name 9-chloro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. Beclomethasone dipropionate is a diester of beclomethasone, a synthetic corticosteroid chemically related to dexamethasone. Beclomethasone differs from dexamethasone in having a chlorine at the 9‑alpha carbon in place of a fluorine, and in having a 16‑beta-methyl group instead of a 16‑alpha-methyl group.

Beclomethasone dipropionate is a white to creamy white, odorless powder with a molecular formula of C 28 H 37 ClO 7 and a molecular weight of 521.1. Its chemical structure is: Chemical Structure QVAR REDIHALER is a pressurized, breath‑actuated, metered‑dose aerosol with a dose counter intended for oral inhalation only. Each unit consists of a sealed breath‑actuated inhaler device enclosing a canister containing a solution of beclomethasone dipropionate in propellant HFA‑134a (1,1,1,2 tetrafluoroethane) and ethanol (0.85 g).

QVAR REDIHALER 40 mcg delivers 40 mcg of beclomethasone dipropionate from the actuator mouthpiece and 50 mcg from the canister valve. QVAR REDIHALER 80 mcg delivers 80 mcg of beclomethasone dipropionate from the actuator mouthpiece and 100 mcg from the canister valve. Both products deliver 50 microliters (59 milligrams) of solution formulation as an aerosol from the canister valve with each actuation.

The 40‑mcg canisters and the 80‑mcg canisters provide 120 inhalations each. Since the QVAR REDIHALER canister is fitted with a primeless valve, no priming actuations are required before use. For both products, an actuation was always triggered by a 20 L/min inspiratory flow rate. structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA‑Approved Patient Labeling (Patient Information and Instructions for Use). Patients should be given the following information: Oropharyngeal Candidiasis Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with QVAR REDIHALER, but at times therapy with QVAR REDIHALER may need to be temporarily interrupted under close medical supervision.

Rinsing the mouth with water without swallowing after inhalation is advised to help reduce the risk of thrush. Status Asthmaticus and Acute Asthma Symptoms Inform patients that QVAR REDIHALER is not a bronchodilator and is not intended for use as rescue medicine for acute asthma exacerbations. Advise patients to treat acute asthma symptoms with an inhaled, short‑acting beta 2 ‑agonist such as albuterol.

Instruct the patient to contact their physicians immediately if there is deterioration of their asthma. Immunosuppression and Risk of Infections Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Hypercorticism and Adrenal Suppression Advise patients that QVAR REDIHALER may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, instruct patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to QVAR REDIHALER.

Immediate Hypersensitivity Reactions Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, and hypotension), including anaphylaxis, may occur after administration of QVAR REDIHALER. Patients should discontinue QVAR REDIHALER if such reactions occur and contact their healthcare provider or get emergency medical help. Reduction in Bone Mineral Density Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.

Reduced Growth Velocity Inform patients that orally inhaled corticosteroids, including QVAR REDIHALER, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of adolescents taking corticosteroids by any route. Ocular Effects Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts, glaucoma or blurred vision); consider regular eye examinations.

Pregnancy Inform patients who are pregnant or nursing that they should contact their physician about the use of QVAR REDIHALER. Use Daily for Best Effect Patients should use QVAR REDIHALER at regular intervals as directed. The daily dosage of QVAR REDIHALER should not exceed 8 inhalations per day.

Advise patients, if they miss a dose, to take their next dose at the same time they normally do. Individual patients will experience a variable time to onset and degree of symptom relief and the full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens.

Instruct patients to not stop use of QVAR REDIHALER abruptly. Patients should contact their physicians immediately if they discontinue use of QVAR REDIHALER. Caring for and Storing the Inhaler For normal hygiene, the mouthpiece of QVAR REDIHALER should be cleaned weekly with a clean, dry tissue or cloth.

Never wash or put any part of QVAR REDIHALER in water. Patient should replace QVAR REDIHALER… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and efficacy of QVAR REDIHALER were evaluated in 1,858 patients with asthma. The development program included 2 confirmatory trials of 12 weeks duration and 1 confirmatory trial of 6 weeks duration in patients 12 years of age and older, and 1 confirmatory trial of 12 weeks duration in patients 4 to 11 years of age. The efficacy of QVAR REDIHALER is based primarily on the confirmatory trials described below.

14.1Trials in the Maintenance Treatment of Asthma Adult and Adolescent Patients 12 Years of Age and Older Two confirmatory clinical trials were conducted comparing QVAR REDIHALER with placebo in adult and adolescent patients with persistent asthma (Trial 1 and Trial 2). Trial 1 (NCT02040779): This randomized, double-blind, parallel-group, placebo-controlled, 12-week, efficacy and safety trial compared QVAR REDIHALER 40 and 80 mcg given as 1 inhalation twice daily with placebo in adult and adolescent patients with persistent symptomatic asthma despite low-dose inhaled corticosteroid or non-corticosteroid asthma therapy.

Patients aged 12 years and older who met the entry criteria including FEV 1 40-85 percent of predicted normal, reversible bronchoconstriction of 15% with short-acting inhaled beta-agonist entered a 14-21 day run-in period. 270 patients (104 previously treated with inhaled corticosteroids) who met all the randomization criteria including asthma symptoms and rescue medication use were discontinued from asthma maintenance medication and randomized equally to treatment with QVAR REDIHALER 80 mcg/day, QVAR REDIHALER 160 mcg/day or placebo.

Baseline FEV 1 values were similar across treatments. The primary endpoint for this trial was the standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV 1 ) area under the effect curve from time zero to 12 weeks [FEV 1 AUEC(0-12wk)]. Patients in both treatment groups had significantly greater improvements in trough FEV 1 compared to placebo (QVAR REDIHALER 80 mcg/day, LS mean change of 0.124 L and QVAR REDIHALER 160 mcg/day, LS mean change of 0.116 L over 12 weeks) (Table 3).

In addition, the mean change from baseline is displayed in Figure 1. Both doses of QVAR REDIHALER were effective in improving asthma control with significantly greater improvements in FEV 1 and morning PEF when compared to placebo. Reduction in asthma symptoms was also supportive of the efficacy of QVAR REDIHALER.

Figure 1: A 12‑Week Clinical Trial in Patients with Asthma: Mean Change in FEV 1 Trial 2 (NCT02513160): This randomized, double-blind, parallel-group, placebo-controlled, 6-week, efficacy and safety trial compared QVAR REDIHALER 40 and 80 mcg given as 4 inhalations twice daily and placebo in adult and adolescent patients with persistent symptomatic asthma despite treatment with non-corticosteroid, inhaled corticosteroids (with or without a long acting beta agonist [LABA]), or combination asthma therapy. The study also included a reference treatment group, QVAR ® Inhalation Aerosol (QVAR MDI) 40 mcg, 4 inhalations twice daily.

Patients aged 12 years and older who met the entry criteria including FEV 1 50-90% predicted normal, reversible bronchoconstriction of at least 10% with short-acting inhaled beta-agonist discontinued baseline asthma treatment and entered a 2-4 week run-in period. 425 patients (257 previously treated with ICS with or without LABA) who met all the randomization criteria including FEV 1 of 40-85% predicted and 15% reversibility with short-acting inhaled beta-agonist, and asthma symptoms were randomized equally to QVAR REDIHALER 320 mcg/day, QVAR REDIHALER 640 mcg/day, QVAR MDI 320 mcg/day or placebo.

Baseline FEV 1 values were similar across treatments. The primary endpoint for this trial was the standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV 1 ) area under the effect curve from time zero to 6 weeks [FEV 1 AUEC(0-6wk)]. Patients in both treatment groups had significantly gre… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenicity of beclomethasone dipropionate was evaluated in rats which were exposed for a total of 95 weeks, 13 weeks at inhalation doses up to 0.4 mg/kg/day and the remaining 82 weeks at combined oral and inhalation doses up to 2.4 mg/kg/day. There was no evidence of treatment‑related increases in the incidence of tumors in this study at the highest dose, which is approximately 37 and 72 times the MRHDID in adults and children, respectively, on a mg/m 2 basis.

Beclomethasone dipropionate did not induce gene mutation in bacterial cells or mammalian Chinese hamster ovary (CHO) cells in vitro . No significant clastogenic effect was seen in cultured CHO cells in vitro or in the mouse micronucleus test in vivo . In rats, beclomethasone dipropionate caused decreased conception rates at an oral dose of 16 mg/kg/day (approximately 250 times the MRHDID in adults on a mg/m 2 basis).

Impairment of fertility, as evidenced by inhibition of the estrous cycle in dogs, was observed following treatment by the oral route at a dose of 0.5 mg/kg/day (approximately 25 times the MRHDID in adults on a mg/m 2 basis). No inhibition of the estrous cycle in dogs was seen following 12 months of exposure to beclomethasone dipropionate by the inhalation route at an estimated daily dose of 0.33 mg/kg (approximately 17 times the MRHDID in adults on a mg/m 2 basis).

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION PATIENT INFORMATION QVAR REDIHALER ® (kue' var red-ee-haye' ler) (beclomethasone dipropionate HFA) inhalation aerosol What is QVAR REDIHALER? QVAR REDIHALER is a breath‑actuated inhaled prescription medicine used as a maintenance treatment for the prevention and control of asthma in people 4 years of age and older. QVAR REDIHALER is not used to relieve sudden breathing problems.

It is not known if QVAR REDIHALER is safe and effective in children less than 4 years of age. Who should not use QVAR REDIHALER? Do not use QVAR REDIHALER: to treat sudden severe symptoms of asthma. as a rescue inhaler. if you are allergic to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER.

See the end of this Patient Information leaflet for a complete list of ingredients in QVAR REDIHALER. What should I tell my healthcare provider before using QVAR REDIHALER? Before using QVAR REDIHALER, tell your healthcare provider about all of your medical conditions, including if you: are exposed to chickenpox or measles. have or have had tuberculosis (TB) or any untreated fungal, bacterial or viral infections, or eye infections caused by herpes. have weak bones (osteoporosis). have an immune system problem. have or have had eye problems, such as blurred vision, increased pressure in your eye (glaucoma) or cataracts. are pregnant or plan to become pregnant.

It is not known if QVAR REDIHALER will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if QVAR REDIHALER passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use QVAR REDIHALER.

Tell your healthcare provider about all of the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use QVAR REDIHALER? Read the step-by-step Instructions for Use for QVAR REDIHALER at the end of this Patient Information leaflet.

Use QVAR REDIHALER exactly as your healthcare provider tells you to. Do not use QVAR REDIHALER more often than it is prescribed. Do not shake the inhaler before using it.

Especially, do not shake the inhaler with the cap open. This could cause the device to accidentally release medicine before you are ready to take it. Do not prime QVAR REDIHALER.

The inhaler does not need to be primed. If your child needs to use QVAR REDIHALER, watch your child closely to make sure your child uses the inhaler correctly. Do not change or stop using QVAR REDIHALER or other asthma medicines used to treat your breathing problems unless your healthcare provider tells you to.

Your healthcare provider will change your medicines as needed. You must use QVAR REDIHALER regularly. It may take 2 to 4 weeks, or longer, after you start using QVAR REDIHALER for your asthma symptoms to get better.

Do not stop using QVAR REDIHALER, even if you are feeling better, unless your healthcare provider tells you to. QVAR REDIHALER comes in 2 strengths (40 mcg and 80 mcg). Your healthcare provider has prescribed the strength that is best for you.

Pay attention to the differences between QVAR REDIHALER and your other inhaled medicines, including their prescribed use and the way they look. QVAR REDIHALER does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms.

Use your rescue inhaler if you have breathing problems between doses of QVAR REDIHALER. If you do not have a rescue inhaler, call your healthcare provider to have a rescue inhaler prescribed for you. Rinse your mouth with water without swallowing after each dose of QVAR REDIHALER.

This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat. Do not spray QVAR REDIHALER in your face or eyes. If you accidentally get QVAR REDIHALER in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider.

What should I avoid while using QVAR REDIHALER? If you have not had, or have not b… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE Instructions for Use QVAR REDIHALER ® (kue' var red-ee-haye’ ler ) (beclomethasone dipropionate HFA) inhalation aerosol Your QVAR REDIHALER Inhaler O verview When you are ready to use your QVAR REDIHALER for the first time, remove the inhaler from the carton. Important information: There is no button. You must close the white cap to prepare the inhaler with medicine before each inhalation .

Do not shake. This breath-actuated device does not need to be shaken. This is not a press-and-breathe inhaler.

Do not prime QVAR REDIHALER . The inhaler does not need to be primed. Do not use a spacer or volume holding chamber with QVAR REDIHALER.

Always use the inhaler in the upright position (with the mouthpiece down). After the inhaler is prepared, it will deliver 1 inhalation of medicine when you breathe in (inhale) through the mouthpiece. Your dose might require more than 1 inhalation.

Do not open the white cap or leave it open unless you are ready for your next inhalation. If the cap has been opened for more than 2 minutes or left in the open position, you will need to close the white cap before use. Do not breathe out or blow into any part of the inhaler.

Breathing out or blowing into the inhaler can damage it. Do not suddenly stop using your QVAR REDIHALER. Contact your healthcare provider immediately if you stop using your QVAR REDIHALER.

There are 2 main parts of your QVAR REDIHALER including: the inhaler body with the mouthpiece. See Figure A. the white cap that covers the mouthpiece of the inhaler. See Figure A.

Figure A About the Dose Counter There is a dose counter in the back of the inhaler with a viewing window that shows you how many inhalations of medicine you have left. See Figure B. Your QVAR REDIHALER contains 120 inhalations.

See Figure B. The counter on the back of your inhaler shows how many inhalations you have left. When there are 20 inhalations left, the numbers in the dose counter will change to red and you should refill your prescription or ask your healthcare provider for another prescription.

When the dose counter shows ‘0’, the background will turn solid red and your inhaler is empty. You should stop using the inhaler and throw it away. Do not put your inhaler into a fire or incinerator.

See Figure B. Figure B Important: The white cap must be closed to prepare the inhaler before each inhalation or you will not receive your medicine. See Figure C.

If the white cap is open, close the white cap to prepare your inhaler and look at the dose counter window to make sure that your inhaler is not empty. See Figure B. Do not open the cap until you are ready to take your inhalation.

Figure C Using your QVAR REDIHALER: Step 1. Open the white cap Open the white cap. See Figure D.

Breathe out fully, away from the inhaler. Do not blow into the inhaler. Figure D Remember: Do not open the cap until you are ready to take your inhalation.

Never breathe out or blow into the inhaler . Breathing out or blowing into the inhaler can damage it. Step 2.

Inhale 1 Time Place the mouthpiece in your mouth and close your lips around it so you form a good seal. Inhale deeply to release the medicine. Remove the inhaler and hold your breath for 5 to 10 seconds, then breathe out slowly, away from the inhaler.

Figure E Remember: Hold the inhaler upright as you take your inhalation. See Figure E. Step 3.

Close the white cap Close the white cap after inhaling to prepare your next inhalation. See Figure F. Figure F If your healthcare provider has told you to take more than 1 inhalation per dose, make sure the white cap is closed and repeat Step 1 to Step 3.

After taking your prescribed number of inhalations, rinse your mouth with water without swallowing to help reduce the risk of a fungal infection (thrush) in your mouth. How to store your QVAR REDIHALER Store QVAR REDIHALER at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Avoid exposure to extreme heat or cold.

Keep the white cap on the inhaler closed during storage.… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 11 words ▾

beclomethasone dipropionate hfa aerosol Label Image

beclomethasone dipropionate hfa Label Image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Qvar Redihaler — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Qvar Redihaler. 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
$16.2M
Claims incl. refills
46.4K
Beneficiaries
33.9K
Spend / beneficiary
$477.59
Spend / claim
$349.36
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 50090-3456-00 · A-S 50090-3459-00 · A-S →
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.