Norgestimate And Ethinyl Estradiol Kit
NDC Package 72789-435-79

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

Package Information

Norgestimate And Ethinyl Estradiol kits is tri-Lo-Marzia™ Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES ( 14)]. This formulation utilizes a kit delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 72789-435 and is authorized under FDA application ANDA200541.

Identification & Billing

NDC Package Code
72789-435-79
Package Description
1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code
72789-435
11-Digit Billing Format
72789043579
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
Norgestimate And Ethinyl Estradiol
Non-Proprietary Name
Norgestimate And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Tri-Lo-Marzia™ Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES ( 14)].

Regulatory & Marketing

Labeler Name
Pd-rx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200541
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2020
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 72789-435-79 identifies a specific commercial package of 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Norgestimate And Ethinyl Estradiol, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This kit is formulated for use and contains 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 Pd-rx Pharmaceuticals, Inc. on January 08, 2020. The current certification is valid through December 31, 2026.

How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72789043579. 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)
72789-435-79
11-Digit CMS (5-4-2)
72789-0435-79

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