Lyleq Tablet
NDC Package 50102-300-13

11-digit billing NDC: 50102030013 · Billing unit: EA · 84 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lyleq (norethindrone) tablets is 1. This formulation utilizes a tablet delivery system. Marketed by Afaxys Pharma, Llc, this product is identified by NDC 50102-300 and is authorized under FDA application ANDA207304.

Identification & Billing

NDC Package Code
50102-300-13
Package Description
3 PACKAGE in 1 CARTON / 1 BLISTER PACK in 1 PACKAGE (50102-300-11) / 28 TABLET in 1 BLISTER PACK (50102-300-01)
Product Code
50102-300
11-Digit Billing Format
50102030013
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
84 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lyleq
Non-Proprietary Name
Norethindrone
Substance Name
Norethindrone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NORETHINDRONE .35 mg/1
Pharmacologic Class
Usage Information
1. Indications  Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.Table 2: 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 anUnintended Pregnancywithin the First  Year of Use% of Women  ContinuingUse at One Year3Method(1)Typical Use1(2)Perfect Use2(3)(4)  Chance48585  Spermicides526640  Periodic abstinence25 63      Calendar 9      Ovulation Method 3      Sympto-Thermal62      Post-Ovulation1  Cap7       Parous Women402642      Nulliparous Women20956  Sponge       Parous Women402042      Nulliparous Women20956  Diaphragm720656  Withdrawal194   Condom8         Female (Reality)21556      Male 14361  Pill5 71      Progestin only 0.5       Combined 0.1   IUDs         Progesterone T21.581      Copper T380A0.80.678      LNg200.10.181  Depo-Provera®0.30.370  Levonorgestrel Implants  (Norplant®)0.050.0588  Female Sterilization0.50.5100  Male Sterilization0.150.1100Emergency Contraceptive Pills Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactational Amenorrhea Method LAM is a highly effective, temporary method of contraception.10 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.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 reason.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.Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.The percentage of women becoming pregnant noted 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 percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. Foams, creams, gels, vaginal suppositories, and vaginal film.Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.With spermicidal cream or jelly.Without spermicides.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 4 yellow pills).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 6 months of age.

Regulatory & Marketing

Labeler Name
Afaxys Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207304
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-23-2016
Listing Expiration
12-31-2027
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 50102-300-13 identifies a specific commercial package of 3 package in 1 carton / 1 blister pack in 1 package (50102-300-11) / 28 tablet in 1 blister pack (50102-300-01) of Lyleq, a human prescription drug labeled by Afaxys Pharma, Llc. This tablet is formulated for oral use and contains norethindrone 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 Afaxys Pharma, Llc on September 23, 2016. The current certification is valid through December 31, 2027.

How is this Afaxys Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50102030013. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 84 total billable units per package. 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)
50102-300-13
11-Digit CMS (5-4-2)
50102-0300-13

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