Podofilox Gel
NDC Package 0574-0621-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Podofilox gel is podofilox solution is used to treat warts on the outside of the genitals. This formulation utilizes a gel delivery system. Marketed by Padagis Us Llc, this product is identified by NDC 0574-0621 and is authorized under FDA application ANDA211871.

Identification & Billing

NDC Package Code
0574-0621-05
Package Description
3.5 g in 1 TUBE, WITH APPLICATOR
Product Code
0574-0621
11-Digit Billing Format
00574062105
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
3.5 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Podofilox
Non-Proprietary Name
Podofilox
Substance Name
Podofilox
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
PODOFILOX 5 mg/g
Pharmacologic Class
Decreased Mitosis - [PE] (Physiologic Effect)
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
Padagis Us Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211871
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-13-2023
Listing Expiration
12-31-2026
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 0574-0621-05 identifies a specific commercial package of 3.5 g in 1 tube, with applicator of Podofilox, a human prescription drug labeled by Padagis Us Llc. This gel is formulated for topical use and contains podofilox 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 Padagis Us Llc on December 13, 2023. The current certification is valid through December 31, 2026.

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 Padagis Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574062105. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 3.5 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)
0574-0621-05
11-Digit CMS (5-4-2)
00574-0621-05

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