Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol Kit
NDC Package 79929-020-07

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

Package Information

Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol kits is desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. This formulation utilizes a kit delivery system. Marketed by Naari Pte. Limited, this product is identified by NDC 79929-020 and is authorized under FDA application ANDA209170.

Identification & Billing

NDC Package Code
79929-020-07
Package Description
3 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code
79929-020
11-Digit Billing Format
79929002007
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
Non-Proprietary Name
Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One YearaMethod(1)Typical Useb(2) Perfect Usec(3) (4)Chance d8585Spermicides e26640Periodic Abstinence2563Calendar9Ovulation Method3Sympto-Thermal f2Post-Ovulation1Withdrawal194Cap gParous Women402642Nulliparous Women20956SpongeParous Women402042Nulliparous Women20956Diaphragm g20656Condom hFemale (Reality)21556Male14361Pill571Progestin Only0.5Combined0.1IUDProgesterone T21.581Copper T 380A0.80.678LNg 200.10.181Depo-Provera0.30.370Norplant and Norplant-20.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Adapted from Hatcher et al., 1998, ref #1.a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. d) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. e) Foams, creams, gels, vaginal suppositories, and vaginal film.f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly.h) Without spermicides.

Regulatory & Marketing

Labeler Name
Naari Pte. Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA209170
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-05-2023
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 79929-020-07 identifies a specific commercial package of 3 blister pack in 1 pouch / 1 kit in 1 blister pack of Desogestrel And Ethinyl Estradiol 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 April 05, 2023. 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: 79929002007. 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)
79929-020-07
11-Digit CMS (5-4-2)
79929-0020-07

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