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  4. NDC Product Code: 82686-300 Miudella

NDC 82686-300 Miudella

Copper Intrauterine Device Intrauterine - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 82686-300?
  5. Miudella Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

This code was recently added to the official NDC directory and the product has entered commercial distribution.

Get all the details for National Drug Code (NDC) 82686-300 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
82686-300
Proprietary Name:
Miudella
Non-Proprietary Name: [1]
Copper
Substance Name: [2]
Copper
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Intrauterine Device - A device inserted and left in the uterus to prevent effective conception.
Administration Route(s): [4]
Intrauterine - Administration within the uterus.
Labeler Name: [5]
Sebela Women's Health Inc.
Labeler Code:
82686
Product Label ID:
9f5c5008-8166-40fa-9627-e9aa620b547e
FDA Application Number: [6]
NDA218201
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-01-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
GRAY (C48324 - GRAY NITINOL FRAME WITH COPPER-COLOR COPPER SLEEVES)

Code Structure Chart

Product Details

What is NDC 82686-300?

The NDC code 82686-300 is assigned by the FDA to the product Miudella which is a human prescription drug product labeled by Sebela Women's Health Inc.. The generic name of Miudella is copper. The product's dosage form is intrauterine device and is administered via intrauterine form. The product is distributed in a single package with assigned NDC code 82686-300-01 1 tray in 1 box, unit-dose / 1 intrauterine device in 1 tray. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Miudella?

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

What are Miudella Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • COPPER 175 mm/1 - A heavy metal trace element with the atomic symbol Cu, atomic number 29, and atomic weight 63.55.

Which are Miudella UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Pharmacologic Classes for Miudella?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".