Norgestimate And Ethinyl Estradiol Kit
NDC Package 79929-009-07

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 norgestimate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions:    •    A high risk of arterial or venous thrombotic diseases. This formulation utilizes a kit delivery system. Marketed by Naari Pte Limited, this product is identified by NDC 79929-009 and is authorized under FDA application ANDA200383.

Identification & Billing

NDC Package Code
79929-009-07
Package Description
3 CARTON in 1 CARTON / 1 KIT in 1 CARTON
Product Code
79929-009
11-Digit Billing Format
79929000907
RxNorm Crosswalk
  • RxCUI: 240128 - norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 240128 - ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet
  • RxCUI: 240128 - ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet
  • RxCUI: 406396 - norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 406396 - ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet

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
Norgestimate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions:    •    A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:          o  Smoke, if over age 35 [see BOXED WARNING AND WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have coronary artery disease [see WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS ( 5.4)]           o   Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS ( 5.6)]           o   Have headaches with focal neurological symptoms or migraine headaches with aura [see WARNINGS AND PRECAUTIONS ( 5.7)]                ■   Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS ( 5.7)]     •    Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS ( 5.2)]     •    Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS ( 5.8)]     •    Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS ( 5.9) AND USE IN SPECIFIC POPULATIONS ( 8.1)]     •    Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see WARNINGS AND PRECAUTIONS ( 5.11)]     •    Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions ( 5.3)]

Regulatory & Marketing

Labeler Name
Naari Pte Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA200383
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2022
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 79929-009-07 identifies a specific commercial package of 3 carton in 1 carton / 1 kit in 1 carton of Norgestimate And Ethinyl Estradiol, a human prescription drug labeled by Naari Pte Limited. 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 Naari Pte Limited on December 31, 2022. The current certification is valid through December 31, 2026.

How is this Naari Pte Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79929000907. 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)
79929-009-07
11-Digit CMS (5-4-2)
79929-0009-07

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