Podofilox
NDC Package 0591-3661-13

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Podofilox is solution is used to treat warts on the outside of the genitals. Marketed by Watson Laboratories, Inc., this product is identified by NDC 0591-3661 and is authorized under FDA application NDA020529.

Identification & Billing

NDC Package Code
0591-3661-13
Package Description
3.5 g in 1 TUBE, WITH APPLICATOR
Product Code
0591-3661
11-Digit Billing Format
00591366113

Clinical Specifications

Proprietary Name
Podofilox
Dosage Form
-
Usage Information
Podofilox solution is used to treat warts on the outside of the genitals. It stops the growth of the wart and the wart eventually falls off. Podofilox belongs to a group of drugs called antimitotics.

Regulatory & Marketing

Labeler Name
Watson Laboratories, Inc.
FDA Application #
NDA020529
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
02-01-2010
End Marketing Date
02-12-2010
Listing Expiration
02-12-2010
Exclude Flag
D
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 0591-3661-13 identifies a specific commercial package of 3.5 g in 1 tube, with applicator of Podofilox, labeled by Watson Laboratories, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Watson Laboratories, Inc. on February 01, 2010. The current certification is valid through February 12, 2010.

What are the primary indications for this medication?

Podofilox solution is used to treat warts on the outside of the genitals. It stops the growth of the wart and the wart eventually falls off. Podofilox belongs to a group of drugs called antimitotics.

How is this Watson Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591366113. 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)
0591-3661-13
11-Digit CMS (5-4-2)
00591-3661-13

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