Saninta 10% Povidone-iodine Liquid
NDC Package 68356-601-01

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

Saninta 10% Povidone-iodine (povidone-iodine solution) liquids is clean the area.apply locally as needed. This formulation utilizes a liquid delivery system. Marketed by Lernapharm, this product is identified by NDC 68356-601 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
68356-601-01
Package Description
3 APPLICATOR in 1 POUCH / 2.3 mL in 1 APPLICATOR
Product Code
68356-601
11-Digit Billing Format
68356060101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Saninta 10% Povidone-iodine
Non-Proprietary Name
Povidone-iodine Solution
Substance Name
Povidone-iodine
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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/mL
Usage Information
Clean the area.apply locally as needed

Regulatory & Marketing

Labeler Name
Lernapharm
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-26-2024
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 (68356-601). Click a package code to view its specific billing and regulatory data.

68356-601-02
22.5 mL in 1 PACKET
68356-601-03
15 mL in 1 PACKET

* 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 68356-601-01 identifies a specific commercial package of 3 applicator in 1 pouch / 2.3 ml in 1 applicator of Saninta 10% Povidone-iodine, a human over the counter drug labeled by Lernapharm. This liquid 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 Lernapharm on February 26, 2024. The current certification is valid through December 31, 2026.

How is this Lernapharm product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68356060101. 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)
68356-601-01
11-Digit CMS (5-4-2)
68356-0601-01

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