Norethindrone And Ethinyl Estradiol Kit
NDC Package 79929-007-07

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

Package Information

Norethindrone And Ethinyl Estradiol kits is norethindrone and ethinyl estradiol tablets, USP 1 mg/0.035 mg are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. This formulation utilizes a kit delivery system. Marketed by Naari Pte Limited, this product is identified by NDC 79929-007 and is authorized under FDA application ANDA206864.

Identification & Billing

NDC Package Code
79929-007-07
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
79929-007
11-Digit Billing Format
79929000707
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Norethindrone And Ethinyl Estradiol
Non-Proprietary Name
Norethindrone And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Norethindrone and ethinyl estradiol tablets, USP 1 mg/0.035 mg are 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT ® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1: 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 Year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.Method (1) Typical Use 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. (2) Perfect Use 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. (3) (4)Adapted from Hatcher et al., 1998, Ref. # 1.Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral ® (1 dose is 2 white pills), Alesse ® (1 dose is 5 pink pills), Nordette ® or Levlen ® (1 dose is 2 light-orange pills), Lo/Ovral ® (1 dose is 4 white pills), Triphasil ® or Tri-Levlen ® (1 dose is 4 yellow pills). Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.Chance 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.8585Spermicides Foams, creams, gels, vaginal suppositories, and vaginal film.26640Periodic abstinence2563  Calendar9  Ovulation Method3  Sympto-Thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2  Post-Ovulation1Cap With spermicidal cream or jelly.  Parous Women402642  Nulliparous Women20956Sponge  Parous Women402042  Nulliparous Women20956Diaphragm 20656Withdrawal194Condom Without spermicides.  Female (Reality ®) 21556  Male14361Pill571  Progestin Only0.5  Combined0.1IUD  Progesterone T2.01.581  Copper T380A0.80.678  LNg 200.10.181Depo-Provera ®0.30.370Norplant ® and Norplant-2 ®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Norethindrone and ethinyl estradiol tablets 1 mg/0.035 mg have not been studied for and are not indicated for use in emergency contraception.

Regulatory & Marketing

Labeler Name
Naari Pte Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206864
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 79929-007-07 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Norethindrone 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: 79929000707. 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)
79929-007-07
11-Digit CMS (5-4-2)
79929-0007-07

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