HomeNDC LookupIngredientsBrensocatib › 71558-0002-30
Brinsupri Brensocatib 25 mg Tablet, 30-count — NDC 71558-0002-30 package photo

Brinsupri Brensocatib 25 mg Tablet, 30-count

by Insmed Incorporated · 30 TABLET in 1 BOTTLE (71558-002-30)
NDC 71558-0002-30
🏷️ FDA NDC (as labeled) 71558-002-30 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 71558-002-30
Product NDC 71558-002
11-digit billing NDC 71558000230
NCPDP billing unit EA — each (per item)
UNII 25CG88L0BB
Application # NDA217673
SPL Set ID b56986ae-e7db-421e-b622-a7f41e321f3d
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-12
Route ORAL
Dosage form TABLET
Substance BRENSOCATIB
GPI-14 45001508000320
GCN Seq No 088126
GCN 58215
HICL code 050812
Ingredient (HICL) Brensocatib
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B68
Therapeutic class — specific (HIC3) Dipeptidyl Peptidase 1 (Dpp1) Inhibitor
AHFS code 48:10.36.00
AHFS class Neutrophil Serine Protease Inhibitors
FDB label name BRINSUPRI 25 MG TABLET
FDB brand name Brinsupri
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 71558-002-30 — 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 → 71558-0002-30. 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.

🏭 Manufacturer & labeler

LabelerInsmed Incorporated
Application holderINSMED INC
FDA applicationNDA217673 (NDA)
Labeler code71558
First marketedAug 2025
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BRINSUPRI 25 MG TABLET Ingredient Brensocatib
📖 What it is MedlinePlus · NLM

Brensocatib is used to treat non-cystic fibrosis bronchiectasis (NCFB; a lung condition caused by inflamed and damaged airways). Brensocatib is in a class of medications called dipeptidyl peptidase 1 (DPP1) inhibitors. It works by decreasing inflammation and improving lung function.

Read the full MedlinePlus article ↗
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.

💊 What it looks like

Color Gray / Brown
ShapeRound
Imprint10;BRE
Size9 mm
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.

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

  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII R8WTH25YS2
    Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.

5 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 DailyMedingredient 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.

💲 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 $243.55 $7,306.43 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $265.55 $7,966.38 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Brinsupri 25 mgthis 71558-0002-30 Insmed 30 tablets FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
First FDA approval
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2040
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 12, 2025 RLD RS ⏳ ~13.5 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 12054465 — drug substance (U-4257)
US 12054465 — drug substance (U-4257)
US 11814359 — drug substance (U-4257)
US 11814359 — drug substance (U-4257)
US 11773069 — method of use (U-4257)
US 11773069 — method of use (U-4257)
US 11673871 — method of use (U-4257)
US 11673871 — method of use (U-4257)
US 11655224 — method of use (U-4257)
US 11655224 — method of use (U-4257)
US 11655223 — drug substance (U-4257)
US 11655223 — drug substance (U-4257)
US 11655222 — drug substance (U-4257)
US 11655222 — drug substance (U-4257)
US 11655221 — method of use (U-4257)
US 11655221 — method of use (U-4257)
US 10669245 — drug substance (U-4257)
US 10669245 — drug substance (U-4257)
US 10287258 — drug substance (U-4257)
US 10287258 — drug substance (U-4257)
US 9815805 — method of use (U-4257)
US 9815805 — method of use (U-4257)
US 12201638 — drug product
US 12201638 — drug product
US 9522894 — drug substance
US 12059424 — drug product
US 9522894 — drug substance
US 12059424 — drug product
Exclusivity NCE
Exclusivity NCE
2025 2027 2029 2031 2033 2035 2037 2039
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 (28)
PatentTypeUse codeExpires
US 12054465 ↗ Drug substance U-4257 Jan 21, 2035
US 12054465 ↗ Drug substance U-4257 Jan 21, 2035
US 11814359 ↗ Drug substance U-4257 Jan 21, 2035
US 11814359 ↗ Drug substance U-4257 Jan 21, 2035
US 11773069 ↗ Method of use U-4257 Jan 21, 2035
US 11773069 ↗ Method of use U-4257 Jan 21, 2035
US 11673871 ↗ Method of use U-4257 Jan 21, 2035
US 11673871 ↗ Method of use U-4257 Jan 21, 2035
US 11655224 ↗ Method of use U-4257 Jan 21, 2035
US 11655224 ↗ Method of use U-4257 Jan 21, 2035
US 11655223 ↗ Drug substance U-4257 Jan 21, 2035
US 11655223 ↗ Drug substance U-4257 Jan 21, 2035
US 11655222 ↗ Drug substance U-4257 Jan 21, 2035
US 11655222 ↗ Drug substance U-4257 Jan 21, 2035
US 11655221 ↗ Method of use U-4257 Jan 21, 2035
US 11655221 ↗ Method of use U-4257 Jan 21, 2035
US 10669245 ↗ Drug substance U-4257 Jan 21, 2035
US 10669245 ↗ Drug substance U-4257 Jan 21, 2035
US 10287258 ↗ Drug substance U-4257 Jan 21, 2035
US 10287258 ↗ Drug substance U-4257 Jan 21, 2035
US 9815805 ↗ Method of use U-4257 Jan 21, 2035
US 9815805 ↗ Method of use U-4257 Jan 21, 2035
US 12201638 ↗ Drug product Mar 1, 2039
US 12201638 ↗ Drug product Mar 1, 2039
US 9522894 ↗ Drug substance Mar 12, 2035
US 12059424 ↗ Drug product Feb 21, 2040
US 9522894 ↗ Drug substance Mar 12, 2035
US 12059424 ↗ Drug product Feb 21, 2040
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Aug 12, 2030
NCENew Chemical Entity (5-year)Aug 12, 2030
Common questions
Is there a generic version of BRINSUPRI 25 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for BRINSUPRI 25 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2040 — an estimate, not a guaranteed launch date.
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 71558-0002-30, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q4 2025 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
257
Units reimbursed last 4 qtrs
7.7K
Gross reimbursed last 4 qtrs
$1.86M
Avg / prescription
$7,249.57
Avg / unit
$243.55
Latest quarter Q4 2025
257Rx
Fee-for-service vs managed care
47% FFS 53% MCO
Fee-for-service · 120 Rx Managed care · 137 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,950 units · 10.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 930 units · 7.9 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 870 units · 2.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 630 units · 13.9 per 100k residents KY West Virginia: no data reported WV Virginia: 420 units · 4.8 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 330 units · 4.6 per 100k residents TN North Carolina: 420 units · 3.9 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 540 units · 11.8 per 100k residents LA Mississippi: no data reported MS Alabama: 450 units · 8.8 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 450 units · 1.5 per 100k residents TX Florida: 660 units · 2.9 per 100k residents FL
Units reimbursed · per 100k residents
1.513.9
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 13.9 /100k
2 Louisiana 11.8 /100k
3 New York 10.0 /100k
4 Alabama 8.8 /100k
5 Ohio 7.9 /100k
6 Virginia 4.8 /100k
7 Tennessee 4.6 /100k
8 North Carolina 3.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Brinsupri — 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 Brinsupri. 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
$212.66M
Claims incl. refills
29K
Beneficiaries
12.5K
Spend / beneficiary
$17,070.16
Spend / claim
$7,332.60
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Brinsupri (this brand).

Top reported reactions

Therapy Interrupted234
Cough221
Headache194
Dyspnoea141
Rash135
Hospitalisation106
Pneumonia105

Age at onset

Child1
Adult13
Elderly25

Reporter sex

2,017 reports
Male · 25%
Female · 75%

Serious outcomes

Hospitalization257
Life-threatening16
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1,727 2
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71558-0002-30 You're viewing this 30 TABLET in 1 BOTTLE (71558-002-30) 2025-08-12 Active

🧭 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) ✓ Available
“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 FDA registers it as 71558-002-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71558-0002-30, written without dashes as 71558000230. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71558-0002-30, the first segment (71558) is the labeler code FDA assigned to Insmed Incorporated; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Insmed Incorporated. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Insmed Incorporated 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.

📄 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 56 words

1 INDICATIONS AND USAGE BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older. ( 1 )

⏱️ Dosage and Administration 82 words

2 DOSAGE AND ADMINISTRATION Recommended dosage: 10 mg or 25 mg orally once daily with or without food. ( 2.1 )

2.1Recommended Dosage The recommended dosage of BRINSUPRI is as follows: 10 mg orally once daily with or without food or 25 mg orally once daily with or without food Missed Dose(s) Patients who miss a dose should take the next dose at their regular time the next day. Do not double the dose to make up for the missed dose.

💊 Dosage Forms and Strengths 49 words

3 DOSAGE FORMS AND STRENGTHS Tablets: 10 mg, brown, round, film-coated tablets debossed with "10" on one side and "BRE" on the other 25 mg, gray, round, film-coated tablets debossed with "25" on one side and "BRE" on the other Tablets: 10 mg and 25 mg ( 3 )

Contraindications 7 words

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~1 min read

5 WARNINGS AND PRECAUTIONS Dermatologic Adverse Reactions : Monitor for new rash or skin conditions and refer to dermatology for evaluation. ( 5.1 ) Gingival and Periodontal Adverse Reactions : Gingival and periodontal adverse reactions can occur with BRINSUPRI use. Refer to the dental care services for regular dental checkups and advise patients to perform routine dental hygiene.

( 5.2 ) Live Attenuated Vaccines : It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of the vaccines. Avoid use of live attenuated vaccines. ( 5.3 )

5.1Dermatologic Adverse Reactions Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis [see Adverse Reactions (6.1) ]. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings.

5.2Gingival and Periodontal Adverse Reactions Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions [see Adverse Reactions (6.1) ]. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene.

5.3Live Attenuated Vaccines The concomitant use of BRINSUPRI and live attenuated vaccines has not been evaluated. It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI.

🤒 Adverse Reactions ~3 min read

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Dermatologic Adverse Reactions [see Warnings and Precautions (5.1) ] Gingival and Periodontal Adverse Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Insmed Incorporated at 1-844-4-INSMED or FDA at 1-800-FDA-1088 or https://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 practice. The safety data below reflect the safety of BRINSUPRI in adult and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis (NCFB). A total of 1721 patients with NCFB were randomized in a double-blind, placebo-controlled clinical trial of 52 weeks duration (ASPEN) [see Clinical Studies (14) ].

The safety of BRINSUPRI was based on data from 1719 adult and pediatric patients aged 12 years and older who received at least one dose of BRINSUPRI or placebo. A total of 1156 patients received at least one dose of BRINSUPRI 10 mg or 25 mg orally once daily. Table 1 shows the adverse reactions occurring at an incidence of ≥2% and higher in BRINSUPRI-treated patients compared to placebo in the safety population from ASPEN.

Table 1 Adverse Reactions with BRINSUPRI with an Incidence of ≥2% and More Common than Placebo in ASPEN Adverse Reaction Placebo (N=563) n (%) BRINSUPRI 10 mg QD (N=582) n (%) BRINSUPRI 25 mg QD (N=574) n (%) Upper respiratory tract infection Upper respiratory tract infection includes coronavirus infection, COVID-19, influenza, upper respiratory tract infection, viral infection, and viral upper respiratory tract infection. 141 (25) 157 (27) 169 (29) Headache 39 (7) 39 (7) 49 (9) Rash Rash includes rash, rash maculo-papular, rash pruritic, rash erythematous, dermatitis, and erythema.

22 (4) 25 (4) 35 (6) Dry skin Dry skin includes dry skin, chapped lips, cheilitis, lip dry, skin exfoliation, skin fissures, xeroderma, and xerosis. 8 (1) 17 (3) 25 (4) Hyperkeratosis Hyperkeratosis includes hyperkeratosis, palmoplantar keratoderma, and skin hypertrophy. 5 (1) 8 (1) 16 (3) Hypertension 17 (3) 28 (5) 13 (2) Adverse Reactions in WILLOW A total of 256 adult patients with NCFB were randomized in the 24-week, double-blind, placebo-controlled clinical trial (WILLOW).

Of those randomized, 255 adult patients received BRINSUPRI 10 mg, BRINSUPRI 25 mg, or placebo, which consisted of 170 adults treated with at least one dose of BRINSUPRI 10 mg or 25 mg orally once daily. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, with the exception of a higher incidence of gingival and periodontal adverse reactions. The incidence of gingival and periodontal adverse reactions in WILLOW among patients treated with BRINSUPRI 10 mg and 25 mg were 9.9% and 10.1%, respectively, compared to 2.4% in placebo-treated patients.

Less Common Adverse Reactions Liver Function Test Elevations In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3× upper limit of normal (ULN) was 0%, 1.2%, and 0.9%, in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. The incidence of AST >3× ULN was 0.2%, 0.3%, and 0.5% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively.

The incidence of alkaline phosphatase >1.5× ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. Skin Cancers In ASPEN, the incidence of skin cancers among p…

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on BRINSUPRI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal embryo fetal development (EFD) studies, oral administration of brensocatib to pregnant rats during organogenesis at maternal exposures 128 times the maximum recommended human dose (MRHD) on an AUC basis was associated with malformations. Oral administration of brensocatib to pregnant rabbits during organogenesis demonstrated no adverse developmental effects at doses that produced maternal exposures up to 20 times the MRHD.

No adverse development effects were observed after oral administration of brensocatib to pregnant rats from the period of organogenesis through lactation at doses that produced maternal exposures 17 times the MRHD on an AUC basis (see Data ) . 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a rat fertility and EFD study, brensocatib was administered at oral doses of 3, 20, and 100 mg/kg/day to female rats 2 weeks prior to mating, during mating, and through organogenesis until gestation Day 16. The malformation of bent scapula was observed at a maternal dose of 100 mg/kg/day (128 times the MRHD on an AUC basis).

There were no adverse findings at maternal oral doses of 20 mg/kg/day (42 times the MRHD on an AUC basis). In a rabbit EFD study, brensocatib was administered at oral doses of 5, 15, or 50 mg/kg/day from gestation Days 7 to 19, a period that covers implantation and major organogenesis. Brensocatib was not associated with adverse effects on the fetus at maternal exposures up to 20 times the MRHD on an AUC basis.

Maternal toxicity as indicated by reductions in body weight gain and food consumption was noted at maternal doses of 15 mg/kg/day and greater (greater than 5 times the MRHD on an AUC basis). In a pre- and postnatal development study, oral administration of brensocatib to pregnant rats at doses of 3, 9, or 20 mg/kg/day from gestation Day 6 through lactation Day 20 resulted in no adverse developmental effects in pups at maternal doses up to 20 mg/kg/day (17 times the MRHD on an AUC basis).

8.2Lactation Risk Summary There are no data on the presence of brensocatib and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Use of BRINSUPRI for this indication is supported by evidence from an adequate and well-controlled trial (ASPEN), which enrolled 41 pediatric patients aged 12 years and older, and additional pharmacokinetic data in pediatric patients aged 12 to 17 years [see Clinical Pharmacology (12.3) and Clinical Studies (14) ]. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults [see Adverse Reactions (6.1) ] .

The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.

8.5Geriatric Use There were 988 patients 65 years of age and older in the clinical studies for non-cystic fibrosis bronchiectasis [see Clinical Studies (14) ] . Of the total number of BRINSUPRI-treated patients in these studies, 676 (51%) were 65 years of age a…

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary There are no available data on BRINSUPRI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal embryo fetal development (EFD) studies, oral administration of brensocatib to pregnant rats during organogenesis at maternal exposures 128 times the maximum recommended human dose (MRHD) on an AUC basis was associated with malformations. Oral administration of brensocatib to pregnant rabbits during organogenesis demonstrated no adverse developmental effects at doses that produced maternal exposures up to 20 times the MRHD.

No adverse development effects were observed after oral administration of brensocatib to pregnant rats from the period of organogenesis through lactation at doses that produced maternal exposures 17 times the MRHD on an AUC basis (see Data ) . 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a rat fertility and EFD study, brensocatib was administered at oral doses of 3, 20, and 100 mg/kg/day to female rats 2 weeks prior to mating, during mating, and through organogenesis until gestation Day 16. The malformation of bent scapula was observed at a maternal dose of 100 mg/kg/day (128 times the MRHD on an AUC basis).

There were no adverse findings at maternal oral doses of 20 mg/kg/day (42 times the MRHD on an AUC basis). In a rabbit EFD study, brensocatib was administered at oral doses of 5, 15, or 50 mg/kg/day from gestation Days 7 to 19, a period that covers implantation and major organogenesis. Brensocatib was not associated with adverse effects on the fetus at maternal exposures up to 20 times the MRHD on an AUC basis.

Maternal toxicity as indicated by reductions in body weight gain and food consumption was noted at maternal doses of 15 mg/kg/day and greater (greater than 5 times the MRHD on an AUC basis). In a pre- and postnatal development study, oral administration of brensocatib to pregnant rats at doses of 3, 9, or 20 mg/kg/day from gestation Day 6 through lactation Day 20 resulted in no adverse developmental effects in pups at maternal doses up to 20 mg/kg/day (17 times the MRHD on an AUC basis).

🧒 Pediatric Use 118 words

8.4Pediatric Use The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Use of BRINSUPRI for this indication is supported by evidence from an adequate and well-controlled trial (ASPEN), which enrolled 41 pediatric patients aged 12 years and older, and additional pharmacokinetic data in pediatric patients aged 12 to 17 years [see Clinical Pharmacology (12.3) and Clinical Studies (14) ]. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults [see Adverse Reactions (6.1) ] .

The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age.

🧓 Geriatric Use 77 words

8.5Geriatric Use There were 988 patients 65 years of age and older in the clinical studies for non-cystic fibrosis bronchiectasis [see Clinical Studies (14) ] . Of the total number of BRINSUPRI-treated patients in these studies, 676 (51%) were 65 years of age and older while 201 (15%) were 75 years of age and older. No observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 17 words

10 OVERDOSAGE Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brensocatib is a competitive, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 activates pro-inflammatory neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow. Activated NSPs are implicated in the pathogenesis of neutrophil-mediated NCFB inflammation.

In cell-based assays, DPP1 inhibition by brensocatib reduces the activity of NSPs including neutrophil elastase, cathepsin G, and proteinase 3.

12.2Pharmacodynamics Brensocatib prevents the activation of NSPs via DPP1 inhibition resulting in decreases in NSP activity in patients. In exploratory assays, brensocatib was associated with dose-dependent reductions in NSP activity in patients with NCFB. Cardiac Electrophysiology At concentrations approximately 2 times the steady state peak concentration of the maximum recommended daily dose of brensocatib in adult and adolescents with NCFB, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics Following once daily administration of brensocatib 10 mg, the estimated geometric mean (CV%) C max is 85.4 ng/mL (33%) and AUC tau is 1360 ng*h/mL (41%). Following once daily administration of brensocatib 25 mg, the estimated geometric mean (CV%) C max is 259 ng/mL (31%) and AUC tau is 4060 ng*h/mL (39%). Brensocatib C max and AUC tau increase in a greater than dose proportional manner between doses of 10 mg and 1.6 times the highest recommended dose.

Between doses of 10 mg and 1.6 times the highest recommended dose brensocatib once daily, brensocatib geometric mean steady state C max increased by 5.1-fold and AUC tau increased by 5.3-fold. In healthy subjects, at steady state, C max increased by about 1.5-fold and AUC tau increased by about 2-fold when compared to those observed following a single dose. No clinically relevant differences in brensocatib pharmacokinetics were observed between healthy subjects and patients with NCFB.

Absorption The absolute oral bioavailability of brensocatib has not been studied in humans. Based on data from a mass balance study in healthy subjects, the oral absorption of brensocatib in humans is greater than 80%. Following a single dose of 10 mg or 25 mg brensocatib, the median (min, max) time to maximum plasma concentration (T max ) is 1.0-1.4 hours (0.5, 3.0 hours).

Effect of Food No clinically relevant differences in brensocatib pharmacokinetics were observed following administration of brensocatib with a high-fat meal (990 calories, 52% fat). Distribution Following once daily administration of 10 mg or 25 mg brensocatib in patients with NCFB, the estimated volume of distribution at steady state ranged from 126 to 138 L. The protein binding of brensocatib in human plasma was 87.2%.

Elimination Following a single oral administration of brensocatib at 10 mg or 25 mg in healthy subjects, the elimination half-life ranged from 25 to 39 hours and the apparent oral clearance ranged from 6.4 to

10.7L/hour. Metabolism Brensocatib is primarily metabolized by CYP3A and to a lesser extent by CYP2C8 and CYP2D6. Brensocatib accounted for 16.2% of the total radioactivity in plasma.

One major circulating metabolite, thiocyanate, was identified in plasma and accounted for 51% of the total radioactivity AUC following administration of a radio-labeled brensocatib dose. In patients with NCFB at recommended doses of brensocatib, no clinically meaningful changes of plasma thiocyanate from baseline were observed. Excretion Following administration of a single oral dose of radiolabeled brensocatib 1.6 times the highest recommended dose to healthy subjects, 54.2% of dose was recovered in urine (22.8% as unchanged brensocatib) and 28.3% of dose was recovered in feces (2.4% as unchanged brensocatib).

Specific Populations No clinically significant differences in the pharmacokinetics of brensocatib were observed based on age (12 to 85 years), sex, race (72% White, 6% Black, and 12% Asian), or body weight (32 to 1…

🧬 Mechanism of Action 60 words

12.1Mechanism of Action Brensocatib is a competitive, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 activates pro-inflammatory neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow. Activated NSPs are implicated in the pathogenesis of neutrophil-mediated NCFB inflammation.

In cell-based assays, DPP1 inhibition by brensocatib reduces the activity of NSPs including neutrophil elastase, cathepsin G, and proteinase 3.

📦 How Supplied / Storage and Handling 99 words

16 HOW SUPPLIED/STORAGE AND HANDLING BRINSUPRI (brensocatib) tablets are supplied as described in Table 4 : Table 4 BRINSUPRI Tablets and Package Configuration Strength Tablet Description Package Configuration NDC 10 mg brown, round, film-coated tablets debossed with "10" on one side and "BRE" on the other bottles of 30 tablets 71558-001-30 25 mg gray, round, film-coated tablets debossed with "25" on one side and "BRE" on the other bottles of 30 tablets 71558-002-30 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store in original container.

📦 Storage and Handling 26 words

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in original container.

📋 Description 172 words

11 DESCRIPTION BRINSUPRI (brensocatib) is a dipeptidyl peptidase 1 (DPP1) inhibitor. The chemical name for the active ingredient brensocatib monohydrate is (2 S )- N -{(1 S )-1-cyano-2-[4-(3-methyl-2-oxo-2,3-dihydro-1,3-benzoxazol-5-yl)phenyl]ethyl}-1,4-oxazepane-2-carboxamide monohydrate with a chemical formula of C 23 H 24 N 4 O 4 ∙ H 2 O which corresponds to a molecular weight of 438.48 g/mol. Its structural formula is: Brensocatib monohydrate drug substance is a white to off-white solid powder.

It is slightly soluble at pH 1.2, freely soluble at pH 4.5, and very slightly soluble at pH 6.8 of aqueous media. It is also soluble in acetonitrile and sparingly soluble in ethanol. BRINSUPRI tablets are available for oral administration in strengths of 10 mg and 25 mg brensocatib with the following inactive ingredients: dibasic calcium phosphate dihydrate, glyceryl dibehenate, microcrystalline cellulose, silicon dioxide, and sodium starch glycolate.

The film coating contains ferrosoferric oxide/black iron oxide, iron oxide yellow, and iron oxide red (10 mg) or ferrosoferric oxide/black iron oxide (25 mg), macrogol/PEG, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. Chemical Structure

💬 Information for Patients 129 words

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dermatologic Adverse Reactions Inform patients that BRINSUPRI is associated with a risk of adverse skin reactions including rash, dry skin, and hyperkeratosis. Advise patients to monitor their skin and report any new rash or skin condition [see Warnings and Precautions (5.1) ] .

Gingival and Periodontal Adverse Reactions Inform patients that BRINSUPRI is associated with a risk of gingival and periodontal adverse reactions. Advise patients to have regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene [see Warnings and Precautions (5.2) ] .

Live Attenuated Vaccines Instruct patients to inform the healthcare provider that they are taking BRINSUPRI prior to a potential vaccination [see Warnings and Precautions (5.3) ] .

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