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  5. NDC Package Code: 65862-886-88 Simliya

NDC Package 65862-886-88 Simliya

Desogestrel And Ethinyl Estradiol 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:
65862-886-88
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code:
65862-886
Proprietary Name:
Simliya
Non-Proprietary Name:
Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
Usage Information:
SIMLIYATM (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) 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 II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.TABLE II: 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 YearaMethod(1)Typical Useb(2)Perfect Usec(3) (4)Chanced85 85  Spermicidese26 6 40 Periodic abstinence 25  63 Calendar  9  Ovulation Method  3  Sympto-Thermalf 2  Post-Ovulation  1  Withdrawal 19 4  Capg   Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge    Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragmg20 6 56 Condomh   Female (Reality) 21 5 56 Male 14 3 61 Pill 5  71 Progestin Only  0.5  Combined  0.1  IUD    Progesterone T 2 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.1100 Adapted from Hatcher et al., 1998, ref #1.a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) 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. c) 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. d) 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. e) Foams, creams, gels, vaginal suppositories, and vaginal film. f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly.h) Without spermicides.
11-Digit NDC Billing Format:
65862088688
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1876810 - {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Simliya 28 Day]
  • RxCUI: 1876810 - SIMLIYA 28 Day Pack
  • RxCUI: 1876810 - Simliya 28 Day Pack
  • RxCUI: 248310 - ethinyl estradiol 0.01 MG Oral Tablet
  • RxCUI: 248310 - ethinyl estradiol 10 MCG 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:
    ANDA206853
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-22-2017
    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
    65862-886-926 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (65862-886-28) / 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-886-88?

    The NDC Packaged Code 65862-886-88 is assigned to a package of 3 pouch in 1 carton / 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Simliya, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is kit and is administered via form.

    Is NDC 65862-886 included in the NDC Directory?

    Yes, Simliya with product code 65862-886 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on March 22, 2017 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 NDC billing unit for package 65862-886-88?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 65862-886-88?

    The 11-digit format is 65862088688. 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
    5-3-265862-886-885-4-265862-0886-88