Elmiron
NDC Package 0062-9800-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Elmiron is a medication used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). Marketed by Ortho-mcneil Pharmaceuticals, this product is identified by NDC 0062-9800 and is authorized under FDA application NDA020193.

Identification & Billing

NDC Package Code
0062-9800-01
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
0062-9800
11-Digit Billing Format
00062980001

Clinical Specifications

Proprietary Name
Elmiron
Dosage Form
-
Usage Information
This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). It may work by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. It is also a weak "blood thinner" and therefore may increase the risk of bruising/bleeding (such as bleeding from the nose/gums).

Regulatory & Marketing

Labeler Name
Ortho-mcneil Pharmaceuticals
FDA Application #
NDA020193
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-26-1996
End Marketing Date
05-31-2012
Listing Expiration
05-31-2012
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0062-9800-01 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Elmiron, labeled by Ortho-mcneil Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Ortho-mcneil Pharmaceuticals on September 26, 1996. The current certification is valid through May 31, 2012.

What are the primary indications for this medication?

This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). It may work by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. It is also a weak "blood thinner" and therefore may increase the risk of bruising/bleeding (such as bleeding from the nose/gums).

How is this Ortho-mcneil Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00062980001. 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)
0062-9800-01
11-Digit CMS (5-4-2)
00062-9800-01

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