Zelapar Tablet, Orally Disintegrating
NDC Package 0187-0453-03

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

Zelapar (selegiline hydrochloride) tablets is a medication used with levodopa/carbidopa to treat movement disorders caused by Parkinson's disease. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Bausch Health Us, Llc, this product is identified by NDC 0187-0453 and is authorized under FDA application NDA021479.

Identification & Billing

NDC Package Code
0187-0453-03
Package Description
1 POUCH in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH
Product Code
0187-0453
11-Digit Billing Format
00187045303
RxNorm Crosswalk
  • RxCUI: 859190 - selegiline HCl 1.25 MG Disintegrating Oral Tablet
  • RxCUI: 859190 - selegiline hydrochloride 1.25 MG Disintegrating Oral Tablet
  • RxCUI: 859192 - Zelapar 1.25 MG Disintegrating Oral Tablet
  • RxCUI: 859192 - selegiline hydrochloride 1.25 MG Disintegrating Oral Tablet [Zelapar]

Clinical Specifications

Proprietary Name
Zelapar
Non-Proprietary Name
Selegiline Hydrochloride
Substance Name
Selegiline Hydrochloride
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SELEGILINE HYDROCHLORIDE 1.25 mg/1
Pharmacologic Class
Usage Information
This medication is used with levodopa/carbidopa to treat movement disorders caused by Parkinson's disease. It does not cure Parkinson's disease, but it may improve shakiness (tremor), muscle stiffness, and sudden switching between normal movement and stiffness ("on-off" problems). It may improve your range of motion and ability to walk, dress, and exercise. Selegiline is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin).

Regulatory & Marketing

Labeler Name
Bausch Health Us, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021479
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-14-2006
Listing Expiration
12-31-2026
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 (0187-0453). Click a package code to view its specific billing and regulatory data.

0187-0453-02
6 POUCH in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH

* 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 0187-0453-03 identifies a specific commercial package of 1 pouch in 1 carton / 10 tablet, orally disintegrating in 1 pouch of Zelapar, a human prescription drug labeled by Bausch Health Us, Llc. This tablet, orally disintegrating is formulated for oral use and contains selegiline hydrochloride 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 Bausch Health Us, Llc on June 14, 2006. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used with levodopa/carbidopa to treat movement disorders caused by Parkinson's disease. It does not cure Parkinson's disease, but it may improve shakiness (tremor), muscle stiffness, and sudden switching between normal movement and stiffness ("on-off" problems). It may improve your range of motion and ability to walk, dress, and exercise. Selegiline is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin).

How is this Bausch Health Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00187045303. 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 (4-4-2)
0187-0453-03
11-Digit CMS (5-4-2)
00187-0453-03

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