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  5. NDC Package Code: 53002-1813-6 Volnea

NDC Package 53002-1813-6 Volnea

Desogestrel 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:
53002-1813-6
Package Description:
6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code:
53002-1813
Proprietary Name:
Volnea
Non-Proprietary Name:
Desogestrel And Ethinyl Estradiol
Usage Information:
Volnea (desogestrel and ethinyl estradiol and ethinyl estradiol) 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 2 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 rate.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 an Unintended Pregnancy within the First Year of Use% of Women Continuing Use atOne YearaMethod(1)Typical Useb(2)Perfect Usec(3)(4)Chanced8585Spermicidese26640Periodic abstinence2563 Calendar9 Ovulation Method3 Sympto-Thermalf2 Post-Ovulation1Withdrawal194Capg Parous Women402642 Nulliparous Women20956Sponge Parous Women402042 Nulliparous Women20956Diaphragmg20656Condomh Female (Reality)21556 Male14361Pill571 Progestin Only0.5 Combined0.1IUD Progesterone T21.581 Copper T 380A0.80.678 LNg 200.10.181Depo-Provera0.30.370Norplant and Norplant-20.050.0588Female sterilization0.50.5100Male sterilization0.150.10100Adapted 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:
53002181306
NDC to RxNorm Crosswalk:
  • RxCUI: 2001756 - {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 [Volnea 28 Day]
  • RxCUI: 2001756 - Volnea 28 Day Pack
  • RxCUI: 248310 - ethinyl estradiol 0.01 MG Oral Tablet
  • RxCUI: 248310 - ethinyl estradiol 10 MCG Oral Tablet
  • RxCUI: 249357 - desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA202689
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-01-2017
    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
    53002-1813-11 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
    53002-1813-33 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-1813-6?

    The NDC Packaged Code 53002-1813-6 is assigned to a package of 6 blister pack in 1 carton / 1 kit in 1 blister pack of Volnea, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 53002-1813 included in the NDC Directory?

    Yes, Volnea with product code 53002-1813 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on December 01, 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 11-digit format for NDC 53002-1813-6?

    The 11-digit format is 53002181306. 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 5-4-1 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
    5-4-153002-1813-65-4-253002-1813-06