Betadine Solution
NDC Package 67618-153-01

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

Package Information

Betadine (povidone-iodine) solution is tear at slit; pull top of packette across, exposing end of swabstickremove Betadine Solution Swabstick and apply as neededuse one time only. This formulation utilizes a solution delivery system. Marketed by Atlantis Consumer Healthcare, Inc., this product is identified by NDC 67618-153 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
67618-153-01
Package Description
1 APPLICATOR in 1 POUCH / 1.9 mL in 1 APPLICATOR
Product Code
67618-153
11-Digit Billing Format
67618015301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Betadine Solution Swabsticks
Non-Proprietary Name
Povidone-iodine
Substance Name
Povidone-iodine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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 10 mg/mL
Usage Information
Tear at slit; pull top of packette across, exposing end of swabstickremove Betadine Solution Swabstick and apply as neededuse one time only

Regulatory & Marketing

Labeler Name
Atlantis Consumer Healthcare, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-1972
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67618-153). Click a package code to view its specific billing and regulatory data.

67618-153-03
3 APPLICATOR in 1 POUCH / 1.9 mL in 1 APPLICATOR

* 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 67618-153-01 identifies a specific commercial package of 1 applicator in 1 pouch / 1.9 ml in 1 applicator of Betadine Solution Swabsticks, a human over the counter drug labeled by Atlantis Consumer Healthcare, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This solution 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 September 15, 1972. The current certification is valid through December 31, 2026.

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: 67618015301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
67618-153-01
11-Digit CMS (5-4-2)
67618-0153-01

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