Povidone Iodine Impregnated Sponge
NDC Package 34645-4010-4

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

Package Information

Povidone Iodine Impregnated (povidone iodine) sponges is usesFor preparation of skin and mucous membranes prior to surgery. This formulation utilizes a sponge delivery system. Marketed by Jianerkang Medical Co., Ltd, this product is identified by NDC 34645-4010 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
34645-4010-4
Package Description
100 mL in 1 POUCH
Product Code
34645-4010
11-Digit Billing Format
34645401004

Clinical Specifications

Proprietary Name
Povidone Iodine Impregnated
Non-Proprietary Name
Povidone Iodine
Substance Name
Povidone-iodine
Dosage Form
Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.
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
UsesFor preparation of skin and mucous membranes prior to surgery

Regulatory & Marketing

Labeler Name
Jianerkang Medical Co., Ltd
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2010
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 34645-4010-4 identifies a specific commercial package of 100 ml in 1 pouch of Povidone Iodine Impregnated, a human over the counter drug labeled by Jianerkang Medical Co., Ltd. This sponge 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, 2010. 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: 34645401004. 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)
34645-4010-4
11-Digit CMS (5-4-2)
34645-4010-04

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