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  5. NDC Package Code: 50458-098-01 Elmiron

NDC Package 50458-098-01 Elmiron

Pentosan Polysulfate Sodium Capsule, Gelatin Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50458-098-01
Package Description:
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code:
50458-098
Proprietary Name:
Elmiron
Non-Proprietary Name:
Pentosan Polysulfate Sodium
Substance Name:
Pentosan Polysulfate Sodium
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).
11-Digit NDC Billing Format:
50458009801
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 199498 - pentosan polysulfate sodium 100 MG Oral Capsule
  • RxCUI: 199498 - pentosan polysulfate 100 MG Oral Capsule
  • RxCUI: 211140 - Elmiron 100 MG Oral Capsule
  • RxCUI: 211140 - pentosan polysulfate 100 MG Oral Capsule [Elmiron]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Pharmaceuticals, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PENTOSAN POLYSULFATE SODIUM 100 mg/1
    • Pharmacologic Class(es):
  • Glycosaminoglycan - [EPC] (Established Pharmacologic Class)
  • Glycosaminoglycans - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA020193
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-26-1996
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 50458-098-01?

    The NDC Packaged Code 50458-098-01 is assigned to a package of 100 capsule, gelatin coated in 1 bottle of Elmiron, a human prescription drug labeled by Janssen Pharmaceuticals, Inc.. The product's dosage form is capsule, gelatin coated and is administered via oral form.

    Is NDC 50458-098 included in the NDC Directory?

    Yes, Elmiron with product code 50458-098 is active and included in the NDC Directory. The product was first marketed by Janssen Pharmaceuticals, Inc. on September 26, 1996 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50458-098-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 50458-098-01?

    The 11-digit format is 50458009801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250458-098-015-4-250458-0098-01