Inbrija Capsule
NDC Package 10144-342-92

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Inbrija (levodopa) capsules is a medication 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. This formulation utilizes a capsule delivery system. Marketed by Merz Pharmaceuticals, Llc, this product is identified by NDC 10144-342 and is authorized under FDA application NDA209184.

Identification & Billing

NDC Package Code
10144-342-92
Package Description
23 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK (10144-342-01)
Product Code
10144-342
11-Digit Billing Format
10144034292
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Inbrija
Non-Proprietary Name
Levodopa
Substance Name
Levodopa
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
LEVODOPA 42 mg/1
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Merz Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA209184
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-22-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10144-342). Click a package code to view its specific billing and regulatory data.

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)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10144-342-92 identifies a specific commercial package of 23 blister pack in 1 carton / 4 capsule in 1 blister pack (10144-342-01) of Inbrija, a human prescription drug labeled by Merz Pharmaceuticals, Llc. This capsule is formulated for respiratory (inhalation) use and contains levodopa as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merz Pharmaceuticals, Llc on December 22, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Merz Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10144034292. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
10144-342-92
11-Digit CMS (5-4-2)
10144-0342-92

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.