NDC Package 82686-300-01 Miudella

Copper Intrauterine Device Intrauterine - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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

Proprietary Name:

Miudella

Non-Proprietary Name:

Copper

Substance Name:

Copper

Usage Information:

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

11-Digit NDC Billing Format:

82686030001

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

1 EA

Product Type:

Human Prescription Drug

Labeler Name:

Sebela Women's Health Inc.

Dosage Form:

Intrauterine Device - A device inserted and left in the uterus to prevent effective conception.

Administration Route(s):

Intrauterine - Administration within the uterus.

Active Ingredient(s):

COPPER 175 mm/1

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

NDA218201

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

10-01-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

82686 - Sebela Women's Health Inc.
- 82686-300 - Miudella
  - 82686-300-01 - 1 TRAY in 1 BOX, UNIT-DOSE / 1 INTRAUTERINE DEVICE in 1 TRAY

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 disclaimer below.

Frequently Asked Questions

What is NDC 82686-300-01?

The NDC Packaged Code 82686-300-01 is assigned to a 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.. The product's dosage form is intrauterine device and is administered via intrauterine form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 82686-300 included in the NDC Directory?

Yes, Miudella with product code 82686-300 is active and included in the NDC Directory. The product was first marketed by Sebela Women's Health Inc. on October 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 82686-300-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 82686-300-01?

The 11-digit format is 82686030001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	82686-300-01	5-4-2	82686-0300-01

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