Betadine
NDC Package 42254-006-30

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 inactivated by the FDA.

Betadine is ® 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices). Marketed by Rebel Distributors Corp, this product is identified by NDC 42254-006 and is authorized under FDA application NDA018634.

Identification & Billing

NDC Package Code
42254-006-30
Package Description
30 mL in 1 BOTTLE
Product Code
42254-006
11-Digit Billing Format
42254000630
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Betadine
Dosage Form
-
Usage Information
BETADINE® 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
NDA018634
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-01-2000
Listing Expiration
12-31-2017
Exclude Flag
I
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 42254-006-30 identifies a specific commercial package of 30 ml in 1 bottle of Betadine, labeled by Rebel Distributors Corp. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. 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 Rebel Distributors Corp on April 01, 2000. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42254000630. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
42254-006-30
11-Digit CMS (5-4-2)
42254-0006-30

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