Miudella Intrauterine Device
NDC Package 82686-300-01

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

Package Information

Miudella (copper) intrauterine devices is miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. This formulation utilizes a intrauterine device delivery system. Marketed by Sebela Women's Health Inc., this product is identified by NDC 82686-300 and is authorized under FDA application NDA218201.

Identification & Billing

NDC Package Code
82686-300-01
Package Description
1 TRAY in 1 BOX, UNIT-DOSE / 1 INTRAUTERINE DEVICE in 1 TRAY
Product Code
82686-300
11-Digit Billing Format
82686030001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Miudella
Non-Proprietary Name
Copper
Substance Name
Copper
Dosage Form
Intrauterine Device - A device inserted and left in the uterus to prevent effective conception.
Administration Route
Intrauterine - Administration within the uterus.
Active Ingredient(s)
COPPER 175 mm/1
Pharmacologic Class
Usage Information
Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.

Regulatory & Marketing

Labeler Name
Sebela Women's Health Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA218201
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2025
Listing Expiration
12-31-2027
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 82686-300-01 identifies a specific commercial package of 1 tray in 1 box, unit-dose / 1 intrauterine device in 1 tray of Miudella, a human prescription drug labeled by Sebela Women's Health Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This intrauterine device is formulated for intrauterine use and contains copper 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 Sebela Women's Health Inc. on December 01, 2025. The current certification is valid through December 31, 2027.

How is this Sebela Women's Health Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82686030001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
82686-300-01
11-Digit CMS (5-4-2)
82686-0300-01

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