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  5. NDC Package Code: 0378-5446-05 Tolterodine Tartrate

NDC Package 0378-5446-05 Tolterodine Tartrate

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0378-5446-05
Package Description:
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
0378-5446
Proprietary Name:
Tolterodine Tartrate
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.
11-Digit NDC Billing Format:
00378544605
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
500 EA
Labeler Name:
Mylan Pharmaceuticals Inc.
Sample Package:
No
FDA Application Number:
ANDA202641
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
11-27-2012
End Marketing Date:
09-30-2014
Listing Expiration Date:
09-30-2014
Exclude Flag:
D
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0378-5446-9160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0378-5446-05?

The NDC Packaged Code 0378-5446-05 is assigned to a package of 500 tablet, film coated in 1 bottle, plastic of Tolterodine Tartrate, labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is and is administered via form.

Is NDC 0378-5446 included in the NDC Directory?

The product was first marketed by Mylan Pharmaceuticals Inc. on November 27, 2012 and its listing in the NDC Directory is set to expire on September 30, 2014 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0378-5446-05?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 500.

What is the 11-digit format for NDC 0378-5446-05?

The 11-digit format is 00378544605. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20378-5446-055-4-200378-5446-05