Betadine Spray
NDC Package 67618-160-03

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Betadine (povidone-iodine) sprays is uses first aid to help prevent infection in minorcutsscrapesburns WarningsFor external use onlyDo not usein the eyesover large areas of the bodyIf you are allergic to povidone-iodine or any other ingredients in this preparation. This formulation utilizes a spray delivery system. Marketed by Atlantis Consumer Healthcare, Inc., this product is identified by NDC 67618-160 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
67618-160-03
Package Description
89 mL in 1 BOTTLE
Product Code
67618-160
11-Digit Billing Format
67618016003
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
89 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Betadine
Non-Proprietary Name
Povidone-iodine
Substance Name
Povidone-iodine
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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)
POVIDONE-IODINE 5 mg/mL
Usage Information
Uses first aid to help prevent infection in minorcutsscrapesburns WarningsFor external use onlyDo not usein the eyesover large areas of the bodyIf you are allergic to povidone-iodine or any other ingredients in this preparation

Regulatory & Marketing

Labeler Name
Atlantis Consumer Healthcare, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-15-1992
End Marketing Date
09-30-2026
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 67618-160-03 identifies a specific commercial package of 89 ml in 1 bottle of Betadine, a human over the counter drug labeled by Atlantis Consumer Healthcare, Inc.. This spray is formulated for topical use and contains povidone-iodine 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 Atlantis Consumer Healthcare, Inc. on April 15, 1992.

How is this Atlantis Consumer Healthcare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67618016003. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 89 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)
67618-160-03
11-Digit CMS (5-4-2)
67618-0160-03

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