Povidone Iodine Prep Solution Sterile Solution
NDC Package 34645-0013-1

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

Package Information

Povidone Iodine Prep Solution Sterile (povidone-iodine) solution is apply locally as needed. This formulation utilizes a solution delivery system. Marketed by Jianerkang Medical Co., Ltd, this product is identified by NDC 34645-0013 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
34645-0013-1
Package Description
30 mL in 1 POUCH
Product Code
34645-0013
11-Digit Billing Format
34645001301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Povidone Iodine Prep Solution Sterile
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 100 mg/mL
Usage Information
Apply locally as needed

Regulatory & Marketing

Labeler Name
Jianerkang Medical Co., Ltd
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2021
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 34645-0013-1 identifies a specific commercial package of 30 ml in 1 pouch of Povidone Iodine Prep Solution Sterile, a human over the counter drug labeled by Jianerkang Medical Co., Ltd. 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 Jianerkang Medical Co., Ltd on January 01, 2021. The current certification is valid through December 31, 2026.

How is this Jianerkang Medical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 34645001301. 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 (5-4-1)
34645-0013-1
11-Digit CMS (5-4-2)
34645-0013-01

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