Necon Kit
NDC Package 51862-892-03

11-digit billing NDC: 51862089203
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Necon (norethindrone and ethinyl estradiol) kits is necon Tablets 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. This formulation utilizes a kit delivery system. Marketed by Mayne Pharma Inc., this product is identified by NDC 51862-892 and is authorized under FDA application ANDA091204.

Identification & Billing

NDC Package Code
51862-892-03
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
51862-892
11-Digit Billing Format
51862089203
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Necon
Non-Proprietary Name
Norethindrone And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Necon Tablets 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.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%.9Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10Source: 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, 1998.1Among 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 reason2 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 reason3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year4 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 altogether5 Foams, creams, gels, vaginal suppositories, and vaginal film6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases7 With spermicidal cream or jelly8 Without spermicides9 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)10 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.% of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One Year3MethodTypical Use1Perfect Use2(1)(2)(3)(4)Chance48585Spermicides526640Periodic abstinence2563Calendar9Ovulation Method3Sympto-Thermal62Post-Ovulation1Cap7Parous Women402642Nulliparous Women20956SpongeParous Women402042Nulliparous Women20956Diaphragm720656Withdrawal194Condom8Female (Reality®)21556Male14361Pill571Progestin Only0.5Combined0.1IUDProgesterone T2.01.581Copper T380A0.80.678LNg 200.10.181Depo-Provera®0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Necon has not been studied for and is not indicated for use in emergency contraception.

Regulatory & Marketing

Labeler Name
Mayne Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091204
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-12-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51862-892). Click a package code to view its specific billing and regulatory data.

51862-892-01
1 BLISTER PACK in 1 PACKET / 1 KIT in 1 BLISTER PACK
51862-892-02
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
51862-892-06
6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

* 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 51862-892-03 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Necon, a human prescription drug labeled by Mayne Pharma Inc.. This kit is formulated for oral 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 Mayne Pharma Inc. on October 12, 2020. The current certification is valid through December 31, 2026.

How is this Mayne Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51862089203. 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)
51862-892-03
11-Digit CMS (5-4-2)
51862-0892-03

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