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  4. NDC Product Code: 10144-342 Inbrija

NDC 10144-342 Inbrija

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10144-342?
  5. Inbrija Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 10144-342 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
10144-342
Proprietary Name:
Inbrija
Product Type: [3]
Labeler Name: [5]
Merz Pharmaceuticals, Llc
Labeler Code:
10144
Product Label ID:
a906f8e1-6e1c-480a-8276-c01bc65dd3be
FDA Application Number: [6]
NDA209184
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
12-22-2018
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
BLACK (C48323)
Shape:
CAPSULE (C48336)
Size(s):
23 MM
Imprint(s):
A42
Score:
1

Code Structure Chart

Product Details

What is NDC 10144-342?

The NDC code 10144-342 is assigned by the FDA to the product Inbrija which is product labeled by Merz Pharmaceuticals, Llc. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 10144-342-04 1 blister pack in 1 carton / 4 capsule in 1 blister pack (10144-342-01), 10144-342-12 3 blister pack in 1 carton / 4 capsule in 1 blister pack (10144-342-01), 10144-342-16 4 blister pack in 1 carton / 4 capsule in 1 blister pack (10144-342-01), 10144-342-32 8 blister pack in 1 carton / 4 capsule in 1 blister pack (10144-342-01), 10144-342-60 15 blister pack in 1 carton / 4 capsule in 1 blister pack (10144-342-01), 10144-342-92 23 blister pack in 1 carton / 4 capsule in 1 blister pack (10144-342-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Inbrija?

This medication is used when needed 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. Parkinson's disease tends to worsen over time, and you may need extra levodopa from time to time to keep symptoms (such as shakiness, stiffness, difficulty moving) from returning. This medication does not replace your regular carbidopa/levodopa medicine. Keep taking your carbidopa/levodopa medicine regularly as directed by your doctor. Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement.

Which are Inbrija UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Inbrija Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Inbrija?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Levodopa Oral Inhalation


Levodopa inhalation is used along with the combination of levodopa and carbidopa (Duopa, Rytary, Sinemet) to treat ''off'' episodes (times of difficulty moving, walking, and speaking that may happen when other medication(s) wear off) in people with Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Levodopa inhalation will not work to prevent ''off'' episodes but will help to control symptoms when an ''off'' episode has already begun. Levodopa is in a class of medications called dopamine agonists. Levodopa works by mimicking the action of dopamine, a natural substance in the brain that is lacking in patients with PD.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".