Elmiron Capsule, Gelatin Coated
NDC Package 50458-098-01

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

Package Information

Elmiron (pentosan polysulfate sodium) capsules is a medication used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Janssen Pharmaceuticals, Inc., this product is identified by NDC 50458-098 and is authorized under FDA application NDA020193.

Identification & Billing

NDC Package Code
50458-098-01
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
50458-098
11-Digit Billing Format
50458009801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Elmiron
Non-Proprietary Name
Pentosan Polysulfate Sodium
Substance Name
Pentosan Polysulfate Sodium
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PENTOSAN POLYSULFATE SODIUM 100 mg/1
Pharmacologic Class
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
Janssen Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020193
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-26-1996
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50458-098-01 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Elmiron, a human prescription drug labeled by Janssen Pharmaceuticals, Inc.. This capsule, gelatin coated is formulated for oral use and contains pentosan polysulfate sodium 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 Janssen Pharmaceuticals, Inc. on September 26, 1996. The current certification is valid through December 31, 2026.

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 Janssen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50458009801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
50458-098-01
11-Digit CMS (5-4-2)
50458-0098-01

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