Aplicare Povidone-iodine Solution
NDC Package 52380-0011-3

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

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Aplicare Povidone-iodine (povidone-iodine) solution is apply locally as needed. This formulation utilizes a solution delivery system. Marketed by Aplicare Products, Llc, this product is identified by NDC 52380-0011 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
52380-0011-3
Package Description
22.5 mL in 1 PACKET
Product Code
52380-0011
11-Digit Billing Format
52380001103
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
22.5 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Aplicare Povidone-iodine
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 10 mg/mL
Usage Information
Apply locally as needed

Regulatory & Marketing

Labeler Name
Aplicare Products, Llc
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-31-2017
End Marketing Date
09-30-2026
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 (52380-0011). Click a package code to view its specific billing and regulatory data.

52380-0011-1
30 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 52380-0011-3 identifies a specific commercial package of 22.5 ml in 1 packet of Aplicare Povidone-iodine, a human over the counter drug labeled by Aplicare Products, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 22.5 billable units per package. 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 Aplicare Products, Llc on May 31, 2017.

How is this Aplicare Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52380001103. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 22.5 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 (5-4-1)
52380-0011-3
11-Digit CMS (5-4-2)
52380-0011-03

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