Miudella
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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. 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

Clinical Specifications

Proprietary Name
Miudella
Dosage Form
-
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.
FDA Application #
NDA218201
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2025
End Marketing Date
06-22-2026
Listing Expiration
06-22-2026
Exclude Flag
D
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, 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 is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sebela Women's Health Inc. on December 01, 2025. The current certification is valid through June 22, 2026.

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.