Povidone Iodine Ointment
NDC Package 69396-112-20

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

Package Information

Povidone Iodine (povidone iodine 10%) ointment is clean the affected area apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.may be covered with a sterile bandage. This formulation utilizes a ointment delivery system. Marketed by Trifecta Pharmaceuticals Usa Llc, this product is identified by NDC 69396-112 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
69396-112-20
Package Description
1 TUBE in 1 BOX / 28.3 g in 1 TUBE
Product Code
69396-112
11-Digit Billing Format
69396011220
RxNorm Crosswalk
  • RxCUI: 312563 - povidone-iodine 10 % Topical Ointment
  • RxCUI: 312563 - povidone-iodine 0.1 MG/MG Topical Ointment
  • RxCUI: 312563 - povidone-iodine 10 % (equal to 1 % available iodine) Topical Ointment

Clinical Specifications

Proprietary Name
Povidone Iodine
Non-Proprietary Name
Povidone Iodine 10%
Substance Name
Povidone-iodine
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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 100 mg/g
Usage Information
Clean the affected area apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily.may be covered with a sterile bandage

Regulatory & Marketing

Labeler Name
Trifecta Pharmaceuticals Usa Llc
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-23-2022
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 69396-112-20 identifies a specific commercial package of 1 tube in 1 box / 28.3 g in 1 tube of Povidone Iodine, a human over the counter drug labeled by Trifecta Pharmaceuticals Usa Llc. This ointment 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 Trifecta Pharmaceuticals Usa Llc on December 23, 2022. The current certification is valid through December 31, 2026.

How is this Trifecta Pharmaceuticals Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69396011220. 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)
69396-112-20
11-Digit CMS (5-4-2)
69396-0112-20

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