Povidone Iodine Prep Solution
NDC Package 34645-5501-0

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 (povidone-iodine) solution is for preparation of the skin prior to surgeryclean the affected area remove swab by stick apply to the operative site prior to surgery. This formulation utilizes a solution delivery system. Marketed by Jianerkang Medical Co., Ltd, this product is identified by NDC 34645-5501 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
34645-5501-0
Package Description
10 BOX in 1 CARTON / 25 PATCH in 1 BOX / .045 g in 1 PATCH
Product Code
34645-5501
11-Digit Billing Format
34645550100

Clinical Specifications

Proprietary Name
Povidone Iodine Prep
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 7.5 g/100g
Usage Information
For preparation of the skin prior to surgeryclean the affected area remove swab by stick apply to the operative site prior to surgery. For use as a first aid antiseptic clean the affected area apply a small amount of this product on the area 1-3 times daily may be covered with a sterile bandage if bandaged,let dry first.

Regulatory & Marketing

Labeler Name
Jianerkang Medical Co., Ltd
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-30-2017
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 34645-5501-0 identifies a specific commercial package of 10 box in 1 carton / 25 patch in 1 box / .045 g in 1 patch of Povidone Iodine Prep, 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 30, 2017. 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: 34645550100. 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)
34645-5501-0
11-Digit CMS (5-4-2)
34645-5501-00

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