Paragard T 380a Intrauterine Device
NDC Package 59365-5129-1

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

Package Information

Paragard T 380a (copper) intrauterine devices is paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. This formulation utilizes a intrauterine device delivery system. Marketed by Coopersurgical, Inc., this product is identified by NDC 59365-5129 and is authorized under FDA application NDA018680.

Identification & Billing

NDC Package Code
59365-5129-1
Package Description
1 POUCH in 1 CARTON / 1 INTRAUTERINE DEVICE in 1 POUCH
Product Code
59365-5129
11-Digit Billing Format
59365512901
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
Paragard T 380a
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 313.4 mg/1
Pharmacologic Class
Usage Information
Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.

Regulatory & Marketing

Labeler Name
Coopersurgical, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA018680
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-15-2024
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59365-5129-1 identifies a specific commercial package of 1 pouch in 1 carton / 1 intrauterine device in 1 pouch of Paragard T 380a, a human prescription drug labeled by Coopersurgical, 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 Coopersurgical, Inc. on August 15, 2024. The current certification is valid through December 31, 2026.

How is this Coopersurgical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59365512901. 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 (5-4-1)
59365-5129-1
11-Digit CMS (5-4-2)
59365-5129-01

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