Sunmark Iodine Tincture
NDC Package 49348-133-27

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

Package Information

Sunmark Iodine (iodine, sodium iodide, alcohol) tinctures is clean the affected area.  Apply a small amount to the affected area 1 to 3 times daily.  May be covered with a sterile bandage.  If bandaged, let dry first. This formulation utilizes a tincture delivery system. Marketed by Strategic Sourcing Services Llc, this product is identified by NDC 49348-133 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
49348-133-27
Package Description
30 mL in 1 BOTTLE
Product Code
49348-133
11-Digit Billing Format
49348013327
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML

Clinical Specifications

Proprietary Name
Sunmark Iodine
Non-Proprietary Name
Iodine, Sodium Iodide, Alcohol
Substance Name
Alcohol; Iodine; Sodium Iodide
Dosage Form
Tincture - An alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances.
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)
Usage Information
Clean the affected area.  Apply a small amount to the affected area 1 to 3 times daily.  May be covered with a sterile bandage.  If bandaged, let dry first.

Regulatory & Marketing

Labeler Name
Strategic Sourcing Services Llc
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-28-2012
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 49348-133-27 identifies a specific commercial package of 30 ml in 1 bottle of Sunmark Iodine, a human over the counter drug labeled by Strategic Sourcing Services Llc. This tincture is formulated for topical use and contains alcohol; iodine; sodium iodide 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 Strategic Sourcing Services Llc on June 28, 2012. The current certification is valid through December 31, 2026.

How is this Strategic Sourcing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348013327. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 total billable units per package. 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)
49348-133-27
11-Digit CMS (5-4-2)
49348-0133-27

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