Cyonanz Kit
NDC Package 65862-899-88

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

Package Information

Cyonanz (norethindrone and ethinyl estradiol) kits is cyonanzTM tablets 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 Aurobindo Pharma Limited, this product is identified by NDC 65862-899 and is authorized under FDA application ANDA207055.

Identification & Billing

NDC Package Code
65862-899-88
Package Description
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (65862-899-28) / 1 KIT in 1 BLISTER PACK
Product Code
65862-899
11-Digit Billing Format
65862089988
RxNorm Crosswalk
  • RxCUI: 1856398 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cyonanz 28 Day]
  • RxCUI: 1856398 - Cyonanz 28 Day Pack
  • RxCUI: 310463 - norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 310463 - ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet
  • RxCUI: 310463 - ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Cyonanz
Non-Proprietary Name
Norethindrone And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
CyonanzTM 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%.§Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. ¶ 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 couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. † 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.‡ 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. § 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).¶ 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. #  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.Þ  Foams, creams, gels, vaginal suppositories, and vaginal film. ß Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.à  With spermicidal cream or jelly.è  Without spermicides.% of Women Experiencing anUnintended Pregnancywithin the First Year of Use% of Women Continuing Use at One Year*Method(1)Typical Use†(2)Perfect Use‡(3)(4)Chance#  8585SpermicidesÞ26640Periodic abstinence 2563    Calendar 9    Ovulation Method 3    Sympto-Thermalß  2    Post-Ovulation 1Capà      Parous Women 402642    Nulliparous Women 20956Sponge     Parous Women 402042    Nulliparous Women 20956Diaphragmà  20656Withdrawal 194Condomè  Female (Reality®) 21556Male 14361Pill 571    Progestin Only 0.5    Combined 0.1IUD     Progesterone T 21.581    Copper T380A 0.80.678    LNg 20 0.10.181Depo-Provera®0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization 0.50.5100Male Sterilization 0.150.1100CyonanzTM has not been studied for and are not indicated for use in emergency contraception.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207055
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-21-2016
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 (65862-899). Click a package code to view its specific billing and regulatory data.

65862-899-92
6 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 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 65862-899-88 identifies a specific commercial package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (65862-899-28) / 1 kit in 1 blister pack of Cyonanz, a human prescription drug labeled by Aurobindo Pharma 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 Aurobindo Pharma Limited on October 21, 2016. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862089988. 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)
65862-899-88
11-Digit CMS (5-4-2)
65862-0899-88

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