Fesoterodine Fumarate Tablet, Extended Release
NDC Package 16262-002-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Fesoterodine Fumarate tablets is a medication used to treat an overactive bladder. This formulation utilizes a tablet, extended release delivery system. Marketed by Aesica Pharmaceuticals Gmbh, this product is identified by NDC 16262-002.

Identification & Billing

NDC Package Code
16262-002-01
Package Description
1 BAG in 1 PAIL / 31250 TABLET, EXTENDED RELEASE in 1 BAG
Product Code
16262-002
11-Digit Billing Format
16262000201

Clinical Specifications

Proprietary Name
Fesoterodine Fumarate
Non-Proprietary Name
Fesoterodine Fumarate
Substance Name
Fesoterodine Fumarate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Active Ingredient(s)
FESOTERODINE FUMARATE 8 mg/1
Usage Information
This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, fesoterodine 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. This medication belongs to the class of drugs known as antispasmodics.

Regulatory & Marketing

Labeler Name
Aesica Pharmaceuticals Gmbh
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
10-31-2008
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 16262-002-01 identifies a specific commercial package of 1 bag in 1 pail / 31250 tablet, extended release in 1 bag of Fesoterodine Fumarate (UNFINISHED drug), drug for further processing labeled by Aesica Pharmaceuticals Gmbh. This tablet, extended release is formulated for use and contains fesoterodine fumarate 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 Aesica Pharmaceuticals Gmbh on October 31, 2008. 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, fesoterodine 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. This medication belongs to the class of drugs known as antispasmodics.

How is this Aesica Pharmaceuticals Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16262000201. 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)
16262-002-01
11-Digit CMS (5-4-2)
16262-0002-01

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