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  5. NDC Package Code: 65862-899-88 Cyonanz

NDC Package 65862-899-88 Cyonanz

Norethindrone And Ethinyl Estradiol Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Cyonanz
Non-Proprietary Name:
Norethindrone And Ethinyl Estradiol
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.
11-Digit NDC Billing Format:
65862089988
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA207055
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-21-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65862-899-926 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-899-88?

    The NDC Packaged Code 65862-899-88 is assigned to a 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. The product's dosage form is kit and is administered via form.

    Is NDC 65862-899 included in the NDC Directory?

    Yes, Cyonanz with product code 65862-899 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on October 21, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65862-899-88?

    The 11-digit format is 65862089988. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265862-899-885-4-265862-0899-88