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  5. NDC Package Code: 79929-008-07 Norgestimate And Ethinyl Estradiol

NDC Package 79929-008-07 Norgestimate And Ethinyl Estradiol

Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
79929-008-07
Package Description:
3 CARTON in 1 CARTON / 1 KIT in 1 CARTON (79929-008-05)
Product Code:
79929-008
Proprietary Name:
Norgestimate And Ethinyl Estradiol
Non-Proprietary Name:
Norgestimate And Ethinyl Estradiol
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)]
11-Digit NDC Billing Format:
79929000807
NDC to 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: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Naari Pte Limited
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA200384
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-31-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 79929-008-07?

    The NDC Packaged Code 79929-008-07 is assigned to a package of 3 carton in 1 carton / 1 kit in 1 carton (79929-008-05) of Norgestimate And Ethinyl Estradiol, a human prescription drug labeled by Naari Pte Limited. The product's dosage form is kit and is administered via form.

    Is NDC 79929-008 included in the NDC Directory?

    Yes, Norgestimate And Ethinyl Estradiol with product code 79929-008 is active and included in the NDC Directory. The product was first marketed by Naari Pte Limited on March 31, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 79929-008-07?

    The 11-digit format is 79929000807. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-279929-008-075-4-279929-0008-07