NDC Package 0054-0065-29 Terbinafine Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

0054-0065-29

Package Description:

500 TABLET in 1 BOTTLE

Product Code:

0054-0065

Proprietary Name:

Terbinafine Hydrochloride

11-Digit NDC Billing Format:

00054006529

Labeler Name:

Roxane Laboratories, Inc.

Sample Package:

FDA Application Number:

ANDA077223

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

07-02-2007

End Marketing Date:

03-09-2011

Listing Expiration Date:

03-09-2011

Exclude Flag:

Code Structure:

0054 - Roxane Laboratories, Inc.
- 0054-0065 - Terbinafine Hydrochloride
  - 0054-0065-29 - 500 TABLET in 1 BOTTLE

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 Code	Package Description
0054-0065-13	30 TABLET in 1 BOTTLE
0054-0065-25	100 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0054-0065-29?

The NDC Packaged Code 0054-0065-29 is assigned to a package of 500 tablet in 1 bottle of Terbinafine Hydrochloride, labeled by Roxane Laboratories, Inc.. The product's dosage form is and is administered via form.

Is NDC 0054-0065 included in the NDC Directory?

The product was first marketed by Roxane Laboratories, Inc. on July 02, 2007 and its listing in the NDC Directory is set to expire on March 09, 2011 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0054-0065-29?

The 11-digit format is 00054006529. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0054-0065-29	5-4-2	00054-0065-29

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