Trospium Chloride Tablet
NDC Package 33342-554-39

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

Package Information

Trospium Chloride tablets is a medication used to treat an overactive bladder. This formulation utilizes a tablet delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-554 and is authorized under FDA application ANDA206472.

Identification & Billing

NDC Package Code
33342-554-39
Package Description
6 BLISTER PACK in 1 CARTON / 15 TABLET in 1 BLISTER PACK
Product Code
33342-554
11-Digit Billing Format
33342055439
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 - A solid dosage form containing medicinal substances with or without suitable diluents.
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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206472
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-18-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (33342-554). Click a package code to view its specific billing and regulatory data.

33342-554-09
60 TABLET in 1 BOTTLE

* 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 33342-554-39 identifies a specific commercial package of 6 blister pack in 1 carton / 15 tablet in 1 blister pack of Trospium Chloride, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet 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 Macleods Pharmaceuticals Limited on June 18, 2024. 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 Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342055439. 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)
33342-554-39
11-Digit CMS (5-4-2)
33342-0554-39

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