Trospium Chloride Er
NDC Package 35573-446-30

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.

Trospium Chloride Er is a medication used to treat an overactive bladder. Marketed by Burel Pharmaceuticals, Llc, this product is identified by NDC 35573-446 and is authorized under FDA application ANDA213185.

Identification & Billing

NDC Package Code
35573-446-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
35573-446
11-Digit Billing Format
35573044630
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Trospium Chloride Er
Dosage Form
-
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
Burel Pharmaceuticals, Llc
FDA Application #
ANDA213185
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-12-2021
End Marketing Date
06-30-2024
Listing Expiration
06-30-2024
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 35573-446-30 identifies a specific commercial package of 30 capsule in 1 bottle of Trospium Chloride Er, labeled by Burel Pharmaceuticals, Llc. 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 Burel Pharmaceuticals, Llc on April 12, 2021. The current certification is valid through June 30, 2024.

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 Burel Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35573044630. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
35573-446-30
11-Digit CMS (5-4-2)
35573-0446-30

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