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Inbrija levodopa 42 mg Capsule, 32-count — NDC 10144-0342-32 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Inbrija levodopa 42 mg Capsule, 32-count — NDC 10144-342-32 (Billing 10144-0342-32)

by Merz Pharmaceuticals, LLC · 8 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK

This is a package of 32 capsules of Inbrija levodopa 42 mg Capsule from Merz Pharmaceuticals, LLC, marketed since Dec 2018 and currently FDA-listed.

NDC 10144-0342-32
🏷️ FDA NDC (as labeled) 10144-342-32 billing pads the product segment with a zero
This package
Contains32-count Pack sizes6 compare ↓
Also priced by: Part D plans $22.89/unit — full pricing hub ↓
Product page 10144-0342-60 Also comes in: 4 capsules 10144-342-04 12 capsules 10144-342-12 16 capsules 10144-342-16 60 capsules 10144-342-60 92 capsules 10144-342-92
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 10144-342-32 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
10144 labeler · 342 product · 32 package
Package marketed since
Dec 22, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 1014434232 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10144-342-32
Product NDC 10144-342
11-digit billing NDC 10144034232
RxCUI 2107616, 2107621
UNII 46627O600J
Application # NDA209184
SPL Set ID a906f8e1-6e1c-480a-8276-c01bc65dd3be
Established class (EPC) Aromatic Amino Acid
Chemical class Amino Acids, Aromatic
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-22
Route RESPIRATORY (INHALATION)
Dosage form CAPSULE
Substance LEVODOPA

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

GPI-14 73200040000160
GPI class Inbrija
GCN Seq No 079392
GCN 45867
HICL code 001897
Ingredient (HICL) Levodopa
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6A
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Other
AHFS code 28:36.16.00
AHFS class Dopamine Precursors
FDB label name INBRIJA 42 MG INHALATION CAP
FDB brand name Inbrija
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079392
  • GCN: 45867
  • GPI-14 (Medi-Span): 73200040000160
  • HICL (First Databank): 001897
  • AHFS class code: 28:36.16.00
  • RxCUI (RxNorm): 2107616
Why two NDCs? The FDA registers this code as 10144-342-32 — 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 → 10144-0342-32. 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 Aromatic Amino Acid class.

Pharmacologic class Aromatic Amino Acid
Drug family (ATC) Dopa and dopa derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name INBRIJA 42 MG INHALATION CAP Ingredient Levodopa
📗 Our plain-language guide HelloPharmacist
  • An OFF episode is when your regular oral Parkinson's medication temporarily stops working as well as it should. You might notice your symptoms — stiffness, slowness, tremor, or dif...
  • What exactly is an OFF episode, and how will I know when I'm having one?
  • Yes, absolutely — Inbrija is not a replacement for your regular carbidopa/levodopa tablets or capsules. It only works when used alongside your oral medication. Think of it as a res...
  • Do I still take my regular Parkinson's pills if I use Inbrija?
📖 Read our full Levodopa Oral Inhalation guide →
2
Nutrient depletion considerations

Levodopa may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Levodopa nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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 $22.89 $732.59 / 32 capsules
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
10144-0342-04 10144-342-04 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK 2019-08-29 — Active
10144-0342-12 10144-342-12 3 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK 2019-08-29 — Active
10144-0342-16 10144-342-16 4 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK 2018-12-22 — Active
10144-0342-32 You're viewing this 8 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK 2018-12-22 — Active
10144-0342-60 10144-342-60 Main listing 15 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK 2018-12-22 — Active
10144-0342-92 10144-342-92 23 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK 2018-12-22 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 32-count package — 8 blister pack in 1 carton / 4 capsule in 1 blister pack.
How does this package differ from NDC 10144-0342-04?
Both are Inbrija levodopa 42 mg Capsule — the drug itself is identical. This page's package is the 32-count one, while NDC 10144-0342-04 is the 4 capsules package.
What NDC number is used to bill for this package of Inbrija levodopa 42 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Inbrija 42 mg 00259-6142-16 Merz 16 capsules — — FDA listed —
Inbrija 42 mgthis 10144-0342-32 Merz 32 capsules — — 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

🏛️
2018
First FDA approval
Dec 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2033
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 Oct 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 21, 2018 RLD RS ⏳ ~7.1 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 12458615 — method of use (U-2484)
US RE43711 — method of use (U-2484)
US 8685442 — drug product
US 8945612 — drug product
US 8545878 — drug product
US 9393210 — drug product
2018 2020 2022 2024 2026 2028 2030 2032
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 (6)
PatentTypeUse codeExpires
US 12458615 ↗ Method of use U-2484 Oct 21, 2033
US RE43711 ↗ Method of use U-2484 Feb 3, 2029
US 8685442 ↗ Drug product — Nov 16, 2032
US 8945612 ↗ Drug product — Nov 16, 2032
US 8545878 ↗ Drug product — Nov 16, 2032
US 9393210 ↗ Drug product — Nov 16, 2032
Common questions
Is there a generic version of INBRIJA 42 MG INHALATION CAP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for INBRIJA 42 MG INHALATION CAP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2033 — 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.

What it looks like

Color White / Black
ShapeCapsule
ImprintA42
Size23 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 2W15RT5V7V
    A phospholipid derived from soy or synthetic sources. It acts as an emulsifier and surfactant to help mix oil and water components, and may improve how the medicine is absorbed in the body.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMerz Pharmaceuticals, LLC
Application holderMERZ PHARMACEUTICALS LLC
FDA applicationNDA209184 (NDA)
Labeler code10144
First marketedDec 2018
Product typeHuman Prescription Drug
Portfolio10 products on file

More NDCs from Merz Pharmaceuticals, LLC labeler code 10144

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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 47 words ▾

1 INDICATIONS AND USAGE INBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa ( 1 )

⏱️ Dosage and Administration 219 words ▾

2 DOSAGE AND ADMINISTRATION INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJA inhaler. For oral inhalation only. DO NOT swallow INBRIJA capsules.

Only use INBRIJA capsules with the INBRIJA inhaler ( 2.1 ) Inhale the contents of two INBRIJA capsules (84 mg) as needed for OFF symptoms, up to 5 times daily ( 2.2 ) The maximum dose per OFF period is 84 mg, and the maximum recommended daily dosage of INBRIJA is 420 mg ( 2.2 )

2.1Important Administration Instructions INBRIJA capsules are for oral inhalation only and should be used only with the INBRIJA inhaler. INBRIJA capsules must not be swallowed as the intended effect will not be obtained. INBRIJA capsules should be stored in their blister package and only removed immediately before use [see How Supplied/Storage and Handling (16.2) ] .

2.2Recommended Dosage INBRIJA should be taken when symptoms of an OFF period start to return. The recommended dosage of INBRIJA is oral inhalation of the contents of two 42 mg capsules (84 mg) as needed, up to 5 times a day. The maximum dose per OFF period is 84 mg, and the maximum daily dosage is 420 mg. INBRIJA has been shown to be effective only in combination with carbidopa/levodopa [see Indications and Usage (1) ].

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS INBRIJA (levodopa inhalation powder) consists of INBRIJA capsules and the INBRIJA inhaler. INBRIJA capsules contain 42 mg dry powder formulation of levodopa in a white capsule with two black color bands, and "A42" printed on one side. Inhalation powder: INBRIJA capsules contain 42 mg levodopa for use with the INBRIJA inhaler ( 3 )

⛔ Contraindications 75 words ▾

4 CONTRAINDICATIONS INBRIJA is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or who have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions (7.1) ]. INBRIJA is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor or who have recently (within 2 weeks) taken a nonselective MAO inhibitor ( 4 , 7.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS May cause falling asleep during activities of daily living ( 5.1 ) Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion ( 5.2 ) Hallucinations/exacerbation of psychosis may occur. Patients with a major psychotic disorder should not be treated with INBRIJA ( 5.3 , 7.2 ) Impulse Control Disorders: consider dose reduction or stopping INBRIJA ( 5.4 ) May cause or exacerbate dyskinesia: adjustment of levodopa therapy may be considered, including stopping INBRIJA ( 5.5 ) Not recommended in patients with asthma, COPD, or other chronic underlying lung disease ( 5.6 )

5.1Falling Asleep During Activities of Daily Living and Somnolence Patients treated with levodopa, the active ingredient in INBRIJA, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence, some reported no warning signs (sleep attack) and believed that they were alert immediately prior to the event. Some of these events have been reported more than 1 year after the initiation of treatment.

Prescribers should reassess patients for drowsiness or sleepiness. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Before initiating treatment with INBRIJA, advise patients about the potential to develop drowsiness and ask about factors that may increase the risk for somnolence with INBRIJA such as the concomitant use of sedating medications and the presence of sleep disorders.

Consider discontinuing INBRIJA in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.). If treatment with INBRIJA continues, patients should be advised not to drive and to avoid other activities that might result in harm if the patients become somnolent. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

5.2Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy.

5.3Hallucinations/Psychosis In placebo-controlled trials [see Clinical Studies (14) ], hallucinations were reported in less than 2% of patients treated with INBRIJA. Hallucinations may be responsive to reducing levodopa therapy. Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming.

Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium. Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should ordinarily not be treated with INBRIJA. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of INBRIJA [see Drug Interactions (7.2) ].

5.4Impulse Control/Compulsive Behaviors Patients treated with INBRIJA can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not reco… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.2) ] Hallucinations/Psychosis [see Warnings and Precautions (5.3) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.4) ] Dyskinesia [see Warnings and Precautions (5.5) ] Bronchospasm in Patients with Lung Disease [see Warnings and Precautions (5.6) ] Glaucoma [see Warnings and Precautions (5.7) ] The most common adverse reactions (incidence ≥ 5% and higher than placebo) were cough, nausea, upper respiratory tract infection, and sputum discolored ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acorda Therapeutics, Inc. at 1-800-367-5109 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Study 1 Table 1 lists the adverse reactions that occurred in at least 2% of patients with Parkinson's disease who were treated with INBRIJA 84 mg and higher than placebo for OFF periods in Study 1 [see Clinical Studies (14) ].

Study 1 was a double-blind, placebo-controlled study, in which 114 patients received INBRIJA 84 mg (two 42 mg capsules) for an average of 2 doses per day, to a maximum of 5 times a day, and 112 patients received placebo. INBRIJA-treated patients were 45-82 years of age (mean 63.5 years of age) and were predominantly male (72%) and white (94%). All patients were also treated with oral carbidopa/levodopa.

The most common adverse reactions (≥ 5% and higher than placebo) in Study 1 were cough, nausea, upper respiratory tract infection, and sputum discolored. Table 1: Adverse Reactions at an Incidence ≥2% and More Frequent with INBRIJA than with Placebo in Study 1 Adverse Reactions INBRIJA 84 mg N=114 % Placebo N=112 % Respiratory, thoracic and mediastinal disorders Cough 15 2 Sputum discolored 5 0 Nasal discharge discoloration 2 0 Oropharyngeal pain 2 0 Gastrointestinal disorders Nausea 5 3 Vomiting 3 0 Infections and infestations Upper respiratory tract infection 6 3 Nasopharyngitis 3 2 Bronchitis/pneumonia 2 0 Nervous system disorders Dyskinesia 4 1 Headache 2 0 Injury, poisoning and procedural complications Fall 3 2 Laceration 2 0 Skin abrasion 2 0 General disorders and administration site conditions Chest discomfort 2 0 Investigations Blood bilirubin increased 2 0 Red blood cell count decreased 2 0 Musculoskeletal and connective tissue disorders Pain in extremity 2 1 Psychiatric disorders Insomnia 2 1 Vascular disorders Orthostatic hypotension/blood pressure decreased 2 0 Adverse Reactions Leading to Discontinuation in Study 1 In Study 1, 6 of 114 patients (5%) in the INBRIJA 84 mg group and 3 of 112 patients (3%) in the placebo group discontinued because of adverse reactions.

The most common of these adverse reactions was cough, which lead to discontinuation in 2% of patients in the INBRIJA 84 mg group and none in the placebo group.

6.2Postmarketing Experience The following adverse reaction has been identified during post approval use of INBRIJA. Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: sensation of choking immediately following administration.

🔄 Drug Interactions 141 words ▾

7 DRUG INTERACTIONS Monitor patients on MAO-B inhibitors for orthostatic hypotension ( 7.1 ) Dopamine D2 antagonists, isoniazid, and iron salts: May reduce the effectiveness of INBRIJA ( 7.2 , 7.3 )

7.1Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with INBRIJA is contraindicated [see Contraindications (4) ] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating INBRIJA. The use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatic hypotension. Monitor patients who are taking these drugs concurrently.

7.2Dopamine D2 Receptor Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Monitor patients for worsening Parkinson's symptoms.

7.3Iron Salts Iron salts or multivitamins containing iron salts can form chelates with levodopa and consequently reduce the bioavailability of levodopa.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of INBRIJA in pregnant women. In animal studies, carbidopa/levodopa has been shown to be developmentally toxic (including teratogenic effects) [see Data ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When administered to pregnant rabbits throughout organogenesis, carbidopa/levodopa caused both visceral and skeletal malformations in rabbits. No teratogenic effects were observed when carbidopa/levodopa was administered to pregnant mice throughout organogenesis.

There was a decrease in the number of live pups delivered by rats receiving carbidopa/levodopa during organogenesis.

8.2Lactation Risk Summary The prolactin-lowering action of dopamine suggests that levodopa may interfere with lactation, although there are limited data on the effects of levodopa on milk production in lactating women. Levodopa has been detected in human milk. There are no adequate data on the effects of levodopa on the breastfed infant.

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

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Of the Parkinson's disease patients in Study 1 who took INBRIJA 84 mg, 49% (n=56) were 65 years of age and older and 51% (n=58) were under 65 years of age. Of these patients, the following age-related differences in adverse reactions were reported in patients 65 years of age and older vs. in patients under 65 years of age, respectively: cough 25% vs. 5%; upper respiratory tract infection 11% vs.

2%; nausea 7% vs. 3%; vomiting 4% vs. 2%; pain in the extremities 4% vs.

0%; and discolored nasal discharge 4% vs. 0%.

🤰 Pregnancy 128 words ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of INBRIJA in pregnant women. In animal studies, carbidopa/levodopa has been shown to be developmentally toxic (including teratogenic effects) [see Data ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When administered to pregnant rabbits throughout organogenesis, carbidopa/levodopa caused both visceral and skeletal malformations in rabbits. No teratogenic effects were observed when carbidopa/levodopa was administered to pregnant mice throughout organogenesis.

There was a decrease in the number of live pups delivered by rats receiving carbidopa/levodopa during organogenesis.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 96 words ▾

8.5Geriatric Use Of the Parkinson's disease patients in Study 1 who took INBRIJA 84 mg, 49% (n=56) were 65 years of age and older and 51% (n=58) were under 65 years of age. Of these patients, the following age-related differences in adverse reactions were reported in patients 65 years of age and older vs. in patients under 65 years of age, respectively: cough 25% vs. 5%; upper respiratory tract infection 11% vs.

2%; nausea 7% vs. 3%; vomiting 4% vs. 2%; pain in the extremities 4% vs.

0%; and discolored nasal discharge 4% vs. 0%.

🆘 Overdosage 127 words ▾

10 OVERDOSAGE Based on the limited available information, the acute symptoms of carbidopa/levodopa overdosage can be expected to arise from dopaminergic overstimulation. Using more than one dose (84 mg) to treat the same OFF period may result in CNS disturbances, with an increasing risk for cardiovascular disturbance (e.g., hypotension, tachycardia) and increased risk for new or worsening psychiatric problems at higher doses. Reports of rhabdomyolysis and transient renal insufficiency suggest that levodopa overdosage may give rise to systemic complications.

Monitor patients and provide supportive care. Patients should receive electrocardiographic monitoring for the development of arrhythmias; if needed, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs, increasing the risk of drug interactions (especially catechol-structured drugs) should be taken into consideration.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Levodopa, the metabolic precursor of dopamine, crosses the blood-brain barrier and presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson's disease.

12.2Pharmacodynamics There are no relevant data on the pharmacodynamic effects of INBRIJA.

12.3Pharmacokinetics In the presence of carbidopa, the pharmacokinetics of levodopa are dose-proportional in healthy subjects taking up to 84 mg of INBRIJA. In the presence of carbidopa, the terminal elimination half-life (t 1/2 ) of levodopa following a single administration of INBRIJA 84 mg was 2.3 hours. Absorption After a single dose of INBRIJA 84 mg (two 42 mg capsules), the median T max for plasma levodopa was approximately 0.5 hours (range 0.17–2.00 hours).

In fasted healthy volunteers the bioavailability of levodopa from INBRIJA was approximately 70% relative to immediate-release oral levodopa tablets. The dose-normalized C max of levodopa from INBRIJA is approximately 50% of that following immediate-release oral tablets. Distribution Apparent volume of distribution (Vz/F) was 168 L for INBRIJA 84 mg.

Metabolism and Elimination Levodopa is extensively metabolized, and the two major metabolic pathways are decarboxylation by dopa decarboxylase and O-methylation by catechol-O-methyltransferase (COMT). Specific Populations Geriatric Population Clinical studies specifically designed to analyze the effects of age on the pharmacokinetics of levodopa were not conducted with INBRIJA. Male and Female Patients After a single dose administration of INBRIJA 84 mg, the body-weight adjusted C max and AUC 0-24 were similar between women and men.

No adjustment in dosage is required based on sex. Hepatic/ Renal Impairment INBRIJA has not been studied in patients with hepatic or renal impairment. Smokers In a pharmacokinetic study following a single administration of INBRIJA 84 mg dose in the presence of carbidopa, levodopa exposure (AUC and C max ) in smokers (N=25) and non-smokers (N=31) were similar.

🧬 Mechanism of Action 37 words ▾

12.1Mechanism of Action Levodopa, the metabolic precursor of dopamine, crosses the blood-brain barrier and presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson's disease.

📦 How Supplied / Storage and Handling 205 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied INBRIJA 42 mg contains foil blister strips of INBRIJA (levodopa inhalation powder) white capsules with two black bands on the body and "A42" in black on the cap, and one INBRIJA inhaler. Carton containing 4 INBRIJA capsules (1 blister card containing 4 capsules) and 1 INBRIJA inhaler: NDC 10144-342-04 Carton containing 12 INBRIJA capsules (3 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-12 Carton containing 60 INBRIJA capsules (15 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-60 Carton containing 92 INBRIJA capsules (23 blister cards containing 4 capsules each) and 1 INBRIJA inhaler: NDC 10144-342-92 INBRIJA inhaler consists of a blue cap, blue handle with "INBRIJA" imprinted on it, and white mouthpiece covering the capsule chamber.

16.2Storage and Handling Store in a dry place between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). INBRIJA capsules should always be stored in the blister packaging and only removed immediately before use. INBRIJA capsules should not be stored inside the INBRIJA inhaler. INBRIJA capsules should be used only with the INBRIJA inhaler. The INBRIJA inhaler should not be used to administer any other medicines.

📦 Storage and Handling 73 words ▾

16.2Storage and Handling Store in a dry place between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). INBRIJA capsules should always be stored in the blister packaging and only removed immediately before use. INBRIJA capsules should not be stored inside the INBRIJA inhaler. INBRIJA capsules should be used only with the INBRIJA inhaler. The INBRIJA inhaler should not be used to administer any other medicines.

📋 Description ~1 min read ▾

11 DESCRIPTION INBRIJA consists of a dry powder formulation of levodopa for oral inhalation with the INBRIJA inhaler. The inhalation powder is packaged in white hypromellose capsules. Each capsule contains a spray-dried powder of 42 mg levodopa active ingredient with 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC) and sodium chloride.

The active component of INBRIJA is levodopa, an aromatic amino acid. Its chemical name is (2S)-2-amino-3-(3,4-dihydroxyphenyl) propanoic acid and its structural formula is: Levodopa has a molecular weight of 197.19 g/mol and molecular formula C 9 H 11 NO 4 . Levodopa is a white to slightly off-white powder and is readily soluble in formic acid, slightly soluble in water, and practically insoluble in ethanol and diethyl ether; it dissolves in dilute hydrochloric acid.

The INBRIJA inhaler is a plastic device with a blue body, blue cap, and white mouthpiece used for inhaling INBRIJA powder. The INBRIJA inhaler is breath-actuated by the patient. Under standardized in vitro testing conditions, the INBRIJA inhaler delivered 36.1 mg of levodopa (emitted dose) for the 42 mg capsule from the mouthpiece.

No significant difference in emitted dose was observed when varying the flow rate and volume from 20 liters per minute/1L up to 90 liters per minute/2L. Peak inspiratory flow rates (PIFR) achievable through the INBRIJA inhaler were evaluated in 24 adult patients with mild to moderate Parkinson's disease. The mean PIFR was 64 L/min (range 39–98 L/min) for patients in the ON state and 57 L/min (range 29–98 L/min) in the OFF state.

Chemical 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). Instructions for Administering INBRIJA It is important for patients to understand how to correctly administer INBRIJA. It is recommended that patients be instructed in the proper administration of INBRIJA prior to use [see Dosage and Administration (2.1) ] .

Patients should be counseled to take a dose of INBRIJA when the return of their Parkinson's symptoms (OFF periods) first occur [see Dosage and Administration (2.2) ] . Instruct patients to read the Instructions for Use before using INBRIJA. Remind patients that INBRIJA capsules should only be administered via the INBRIJA inhaler and the INBRIJA inhaler should not be used for administering other medications.

Remind patients that the contents of INBRIJA capsules are for oral inhalation only and must not be swallowed. Instruct patients to keep INBRIJA capsules in their sealed blister packaging and to remove each INBRIJA capsule immediately before using [see Dosage and Administration (2.1) ] . Remind patients they need to orally inhale the contents of two capsules to take a full dose.

They should not take more than 5 doses of INBRIJA in one day. Instruct patients they should not take more than one dose (2 capsules) per OFF period [see Dosage and Administration (2.2) ] . Lung Disease Ask patients to report whether they develop asthma, COPD, or other chronic lung diseases, since INBRIJA is not recommended in patients with these conditions [see Warnings and Precautions (5.6) ] .

Cough/Sensation of Choking Inhalation of INBRIJA can lead to coughing or a sensation of choking at the time of administration [see Warnings and Precautions (5.6) , and Adverse Reactions (6.1 , 6.2) ] . Discoloration of Body Fluids Patients should be advised that dark color may appear in bodily fluids (saliva, sputum, urine, or sweat) when using INBRIJA [see Adverse Reactions (6.1) ] . Falling Asleep Advise patients that certain side effects such as sleepiness and dizziness may affect some patients' ability to drive and operate machinery safely.

Advise patients of the possible additive sedative effects when taking other CNS depressants in combination with INBRIJA [see Warnings and Precautions (5.1) ] . Impulse Control Disorder Inform patients of the potential for experiencing Impulse Control Disorder: patients may experience intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson's disease [see Warnings and Precautions (5.4) ] .

Dyskinesia Instruct patients to notify their healthcare provider if abnormal involuntary movements appear or get worse during treatment with INBRIJA [see Warnings and Precautions (5.5) ] . Hypotension and Syncope Advise patients that while they are on levodopa therapy, including INBRIJA, that they may develop orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sweating [see Adverse Reactions (6.1) ] . Advise patients to rise slowly after sitting or lying down, especially if they have been doing so for a prolonged period.

Iron Salts Inform patients that iron salts or multivitamins containing iron salts can reduce the bioavailability of levodopa [see Drug Interactions (7.3) ]. Pregnancy and Breastfeeding Instruct patients to notify their physicians if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1) ] . Instruct patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant [see Use in Specific Populations (8.2) ] .

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics In the presence of carbidopa, the pharmacokinetics of levodopa are dose-proportional in healthy subjects taking up to 84 mg of INBRIJA. In the presence of carbidopa, the terminal elimination half-life (t 1/2 ) of levodopa following a single administration of INBRIJA 84 mg was 2.3 hours. Absorption After a single dose of INBRIJA 84 mg (two 42 mg capsules), the median T max for plasma levodopa was approximately 0.5 hours (range 0.17–2.00 hours).

In fasted healthy volunteers the bioavailability of levodopa from INBRIJA was approximately 70% relative to immediate-release oral levodopa tablets. The dose-normalized C max of levodopa from INBRIJA is approximately 50% of that following immediate-release oral tablets. Distribution Apparent volume of distribution (Vz/F) was 168 L for INBRIJA 84 mg.

Metabolism and Elimination Levodopa is extensively metabolized, and the two major metabolic pathways are decarboxylation by dopa decarboxylase and O-methylation by catechol-O-methyltransferase (COMT). Specific Populations Geriatric Population Clinical studies specifically designed to analyze the effects of age on the pharmacokinetics of levodopa were not conducted with INBRIJA. Male and Female Patients After a single dose administration of INBRIJA 84 mg, the body-weight adjusted C max and AUC 0-24 were similar between women and men.

No adjustment in dosage is required based on sex. Hepatic/ Renal Impairment INBRIJA has not been studied in patients with hepatic or renal impairment. Smokers In a pharmacokinetic study following a single administration of INBRIJA 84 mg dose in the presence of carbidopa, levodopa exposure (AUC and C max ) in smokers (N=25) and non-smokers (N=31) were similar.

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics There are no relevant data on the pharmacodynamic effects of INBRIJA.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy and safety of INBRIJA for the treatment of OFF episodes in patients with Parkinson's disease treated with oral carbidopa/levodopa was evaluated in a 12-week, randomized, placebo-controlled, double-blind study (Study 1; NCT02240030). Study 1: In Study 1, a total of 114 patients were treated with INBRIJA 84 mg (two 42 mg capsules), and 112 patients received placebo. Study medication could be administered up to five times a day.

At baseline, patients had at least 2 hours of OFF time per day, and carbidopa/levodopa medication did not exceed 1600 mg levodopa per day. The mean UPDRS Part III scores at screening in the ON state were 14.9 for patients randomized to INBRIJA 84 mg and 16.1 for patients randomized to placebo. The UPDRS part III is designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability) in patients with Parkinson's disease.

The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor score from pre-dose OFF state to 30 minutes post-dose, measured at Week 12. The average use of INBRIJA 84 mg or placebo was approximately 2 doses per day. At Week 12, the reduction in UPDRS Part III motor score for INBRIJA 84 mg, compared to placebo at 30 minutes post-dose, were -9.8 and -5.9, respectively (See Table 2 and Figure 1 ).

The proportion of patients who returned to an ON state and sustained that ON through 60 minutes post-dose was 58% for INBRIJA 84 mg and 36% for placebo (p=0.003). Table 2: Mean Change in UPDRS Part III Motor Score at 30 minutes post-dose (INBRIJA 84 mg) for the Intent-to-Treat Population at Week 12 Treatment group least-squares mean change is a model-based population estimate; the pre-dose and post-dose means are descriptive statistics. Treatment Pre-dose (OFF) UPDRS Part III Motor Score (mean) Post-dose UPDRS Part III Motor Score (mean) Mean Change 30 minutes post-dose Least-squares mean. , Negative numbers indicate improvement as compared with the baseline value.

Difference from Placebo (95% confidence interval) p-value Placebo 32.1 25.3 -5.9 — — INBRIJA 84 mg 29.0 19.3 -9.8 -3.92 (-6.84, -1.00) 0.009 Figure 1: Least-squares Mean Change in UPDRS Part III Motor Score After Administration of INBRIJA 84 mg vs. Placebo (at Week 12) Figure 1 Study 2 The effect of INBRIJA on pulmonary function was evaluated in patients with Parkinson's disease treated with oral carbidopa/levodopa in a 12 month, randomized, controlled, open-labeled study (Study 2: NCT02352363). A total of 271 patients were treated with INBRIJA 84 mg (two 42 mg capsules), and 127 patients with Parkinson's disease in a control group were observed on their regular oral medication regimen for the treatment of Parkinson's disease.

Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last 5 years were excluded [see Warnings and Precautions (5.6) ]. Pulmonary function was assessed by spirometry every 3 months in both groups. After 12 months, the average reduction in the forced expiratory volume in 1 second (FEV 1 ) from baseline was the same in both groups (-0.1 L).

🧪 Nonclinical Toxicology 59 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In rats, oral administration of carbidopa/levodopa for two years resulted in no evidence of carcinogenicity. Mutagenesis Studies to assess the potential mutagenic or clastogenic effects of levodopa have not been conducted. Impairment of Fertility In reproduction studies in rats, oral administration of carbidopa/levodopa resulted in no effects on fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 56 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In rats, oral administration of carbidopa/levodopa for two years resulted in no evidence of carcinogenicity. Mutagenesis Studies to assess the potential mutagenic or clastogenic effects of levodopa have not been conducted. Impairment of Fertility In reproduction studies in rats, oral administration of carbidopa/levodopa resulted in no effects on fertility.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 12/2022 PATIENT INFORMATION INBRIJA ® (in-BRIH-jah) (levodopa inhalation powder) for oral inhalation use What is INBRIJA? INBRIJA is an inhaled prescription levodopa medicine used to treat the return of Parkinson's symptoms (known as OFF episodes) in people with Parkinson's disease who are treated with carbidopa-levodopa medicines.

It does not replace the regular carbidopa-levodopa medicines. It is not known if INBRIJA is safe or effective in children. Do not use INBRIJA if you: take another medicine called a nonselective monoamine oxidase inhibitor (MAOI), such as phenelzine and tranylcypromine, or have taken a nonselective MAOI within the last 2 weeks.

Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI. Before you use INBRIJA, tell your healthcare provider about all of your medical conditions, including if you: have asthma, chronic obstructive pulmonary disease (COPD), or any chronic lung disease. have daytime sleepiness from a sleep disorder or get drowsy or sleepy without warning or take a medicine to help you sleep. feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down. have a history of abnormal movement (dyskinesia). have or have had a mental health problem such as hallucinations or psychosis. have urges that you are unable to control (for example, gambling, increased sexual urges, intense urges to spend money, or binge eating). have glaucoma. are pregnant or plan to become pregnant.

It is not known if INBRIJA will harm your unborn baby. are breastfeeding or plan to breastfeed. Levodopa the medicine in INBRIJA can pass into your breastmilk. It is not known if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using INBRIJA and certain other medicines may affect each other and cause serious side effects. Especially tell your healthcare provider if you take: MAO-B inhibitors dopamine D2 receptor antagonists, including phenothiazines, butyrophenones, risperidone, and metoclopramide, or isoniazid iron salts or multivitamins with iron salts Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. How should I use INBRIJA?

See the step-by-step Instructions for Use that come with your INBRIJA prescription. Your healthcare provider should show you the right way to use INBRIJA before you start using it. INBRIJA is for oral inhalation use only.

Do not swallow INBRIJA capsules. Do not open INBRIJA capsules. Only use INBRIJA capsules with the INBRIJA inhaler.

Do not use the INBRIJA inhaler to take any other medicine. You must be taking a daily Parkinson's disease medicine that contains carbidopa and levodopa before you start taking INBRIJA. You must not stop taking your daily Parkinson's medicine.

INBRIJA does not replace your daily medicine. Use INBRIJA exactly as prescribed. The dose of INBRIJA is 2 capsules.

Do not take more than 1 dose (2 capsules) for any OFF period. Take an INBRIJA dose as soon as you feel Parkinson's symptoms start to return. Do not take more than 5 doses of INBRIJA in 1 day.

What should I avoid while using INBRIJA? Do not drive, operate machinery, or do other activities until you know how INBRIJA affects you. INBRIJA can cause sleepiness and falling asleep suddenly as late as 1 year after you start treatment.

What are the possible side effects of INBRIJA? INBRIJA can cause serious side effects including: falling asleep during normal daily activities. INBRIJA may cause you to fall asleep while you are doing normal daily activities such as driving a car, doing physical tasks, using hazardous machinery, talking with other people, or eating.

You could fall asleep without… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE INBRIJA ® (in-BRIH-jah) (levodopa inhalation powder) For Oral Inhalation Only Read and follow these instructions before you start using INBRIJA and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important Information about using INBRIJA Do not swallow INBRIJA capsules INBRIJA capsules should only be used with the INBRIJA inhaler and inhaled through your mouth (oral inhalation) Overview: A complete dose is 2 capsules. You will load 1 capsule into the inhaler and breathe in (inhale). Then, you will remove the used capsule and load a second capsule into the inhaler and breathe in.

Do not swallow INBRIJA capsules. Each carton contains 1 INBRIJA inhaler and capsules in sealed foil packages. When you open a new carton, always use the new inhaler supplied.

Do not use capsules after the expiration date printed on the package. Do not load 2 capsules at the same time. Throw out all used capsules immediately after use.

Throw out the inhaler after all capsules in the carton have been used. Make sure your hands are clean and dry when using the inhaler and capsules. If you have any questions, ask your healthcare provider or pharmacist.

If you have problems using INBRIJA, or if your INBRIJA inhaler becomes lost or damaged and you need a replacement, contact INBRIJA support at 1-800-367-5109. Then, call your healthcare provider for treatment instructions until you receive your replacement inhaler. Parts of your INBRIJA Inhaler (see Figure A ) Capsules (see Figure B ) Each carton includes strips of 4 capsules.

(see Figure C ) Prepare and take a total of 2 capsules. Take each capsule 1 at a time for a full dose. (see Figure D ) Full Dose = 2 Capsules Prepare Your Dose Step 1.

Gather Supplies Find a clean and dry surface. Make sure your hands are clean and dry. Get inhaler and strip of capsules.

Tear off package of 2 capsules (see Figure E ). Step 2. Check Expiration Check the expiration date on the package (see Figure F ).

Step 3. Remove Blue Cap Pull the cap straight off (see Figure G ). Place the cap to the side.

You will need it later to store the inhaler. Step 4. Twist Off White Mouthpiece Twist and pull off the mouthpiece to separate it from the handle (see Figure H ).

Place the mouthpiece and inhaler on a clean and dry surface. Step 5. Remove 1 Capsule From Package Carefully peel back the foil and take out 1 capsule (see Figure I ).

Do not try to push the capsule through the back of the foil package. Only remove 1 capsule at a time, and just before use. Do not use any capsule that looks crushed, damaged or wet.

Throw it away and get a new capsule. Step 6. Load Capsule Hold the inhaler upright using the handle.

Drop 1 capsule into the opening of the capsule chamber (see Figure J ). Do not try to load 2 capsules at the same time. Step 7.

Attach White Mouthpiece Line up the white arrows on the handle and mouthpiece (see Figure K ). Firmly push the mouthpiece and handle together until you hear a click. This punctures the capsule (see Figure L ).

Release the mouthpiece. The mouthpiece will spring back and stay attached (see Figure M ). Your inhaler is now ready to use.

Do not push the handle and mouthpiece together more than 1 time. This may damage the capsule, and you may not get your full dose. If this happens throw the capsule away in your household trash and start over at Step 5.

Make sure the mouthpiece is securely attached and will not fall off before moving to step 8. Take Your Dose Step 8. Breathe Out (Exhale) Stand or sit with your head and chest upright.

Hold the inhaler level and away from your mouth (see Figure N ). Breathe out completely (see Figure N ). Do not breathe into mouthpiece.

Step 9. Breathe In Deeply (Inhale) While keeping the inhaler level, close your lips firmly around the mouthpiece (see Figure O ). Take in a deep, comfortable breath until your lungs feel full.

This no… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 60 words ▾

PRINCIPAL DISPLAY PANEL - 42 mg Capsule Blister Pack Carton NDC 10144-342-60 Rx ONLY Inbrija® (levodopa inhalation powder) For Oral Inhalation Only 42 mg capsules CONTENTS: 60 capsules (15 blister strips of 4 capsules each) 1 inhaler Prescribing Information Patient Information Instructions for Use Do not swallow Inbrija® capsules Inbrija® capsules are for use with Inbrija® inhaler only. 60-count carton

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 capsules10144-0342-60 196 Rx · $495,462
4 capsules10144-0342-04 No Medicaid data
12 capsules10144-0342-12 No Medicaid data
16 capsules10144-0342-16 No Medicaid data
32 capsules this page10144-0342-32 No Medicaid data
92 capsules10144-0342-92 No Medicaid data
Drug total (last 4 qtrs): 196 Rx · 22,740 units · $495,462 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Inbrija — 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 Inbrija. 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
$7.76M
Claims incl. refills
2.3K
Beneficiaries
1.3K
Spend / beneficiary
$5,977.89
Spend / claim
$3,343.08
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 Inbrija (this brand).

Top reported reactions

Cough2,270
Parkinson^s Disease1,074
Dyskinesia760
Death716
Fall705
Device Issue694
Condition Aggravated687

Age at onset

Neonate1
Child11
Adolescent3
Adult224
Elderly570

Reporter sex

12,013 reports
Male · 56%
Female · 44%
Unknown · 0%

Serious outcomes

Hospitalization2,717
Death1,359
Life-threatening270
Disabling148
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,286 0
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Merz Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 4 capsules (10144-0342-04), 12 capsules (10144-0342-12), 16 capsules (10144-0342-16). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Merz Pharmaceuticals, LLC 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.
← 10135-0838-01 · Marlex 10144-0427-60 · Merz →
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.