Trospium Chloride Tablet, Film Coated
NDC Package 76282-336-60

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

Package Information

Trospium Chloride tablets is a medication used to treat an overactive bladder. This formulation utilizes a tablet, film coated delivery system. Marketed by Exelan Pharmaceuticals Inc., this product is identified by NDC 76282-336 and is authorized under FDA application ANDA091688.

Identification & Billing

NDC Package Code
76282-336-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
76282-336
11-Digit Billing Format
76282033660
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
RxCUI: 857560 - trospium chloride 20 MG Oral Tablet

Clinical Specifications

Proprietary Name
Trospium Chloride
Non-Proprietary Name
Trospium Chloride
Substance Name
Trospium Chloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TROSPIUM CHLORIDE 20 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, trospium improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. Trospium belongs to a class of drugs known as antispasmodics. It is also known as an antimuscarinic.

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091688
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-11-2017
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 76282-336-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Trospium Chloride, a human prescription drug labeled by Exelan Pharmaceuticals Inc.. This tablet, film coated is formulated for oral use and contains trospium chloride 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 Exelan Pharmaceuticals Inc. on July 11, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, trospium improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. Trospium belongs to a class of drugs known as antispasmodics. It is also known as an antimuscarinic.

How is this Exelan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282033660. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
76282-336-60
11-Digit CMS (5-4-2)
76282-0336-60

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