Tolterodine Tartrate Capsule, Extended Release
NDC Package 0904-6593-04

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Tolterodine Tartrate (tolterodine) capsules is a medication used to treat an overactive bladder. This formulation utilizes a capsule, extended release delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-6593 and is authorized under FDA application ANDA203016.

Identification & Billing

NDC Package Code
0904-6593-04
Package Description
30 BLISTER PACK in 1 CARTON / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0904-6593
11-Digit Billing Format
00904659304
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 855182 - tolterodine tartrate 2 MG 24HR Extended Release Oral Capsule
  • RxCUI: 855182 - 24 HR tolterodine tartrate 2 MG Extended Release Oral Capsule
  • RxCUI: 855182 - tolterodine tartrate 2 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 855189 - tolterodine tartrate 4 MG 24HR Extended Release Oral Capsule
  • RxCUI: 855189 - 24 HR tolterodine tartrate 4 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Tolterodine Tartrate
Non-Proprietary Name
Tolterodine
Substance Name
Tolterodine Tartrate
Dosage Form
Capsule, Extended Release - 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, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TOLTERODINE TARTRATE 4 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, tolterodine 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
Major Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA203016
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-11-2015
End Marketing Date
07-31-2026
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 0904-6593-04 identifies a specific commercial package of 30 blister pack in 1 carton / 1 capsule, extended release in 1 blister pack of Tolterodine Tartrate, a human prescription drug labeled by Major Pharmaceuticals. This capsule, extended release is formulated for oral use and contains tolterodine tartrate 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 Major Pharmaceuticals on August 11, 2015.

What are the primary indications for this medication?

This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, tolterodine 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 Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904659304. 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 (4-4-2)
0904-6593-04
11-Digit CMS (5-4-2)
00904-6593-04

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