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  5. NDC Package Code: 0378-7296-53 Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol

NDC Package 0378-7296-53 Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol

Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0378-7296-53
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-7296-85) / 1 KIT in 1 BLISTER PACK
Product Code:
0378-7296
Proprietary Name:
Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
Non-Proprietary Name:
Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
Usage Information:
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.†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.* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.§ 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.¶ 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.Þ With spermicidal cream or jelly.ß Without spermicides.% of Women Experiencing an UnintendedPregnancy within the First Year of Use% of WomenContinuing Use atOne Year*Method(1)Typical Use† (2)Perfect Use‡ (3)(4)Chance§8585Spermicides¶26640Periodic abstinence2563     Calendar9     Ovulation Method3     Sympto-Thermal#2     Post-Ovulation1Withdrawal194CapÞ     Parous Women402642     Nulliparous Women20956Sponge     Parous Women402042     Nulliparous Women20956DiaphragmÞ20656Condomß     Female (Reality)21556     Male14361Pill571     Progestin Only0.5     Combined0.1IUD     Progesterone T2.01.581     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.
11-Digit NDC Billing Format:
00378729653
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: 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
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA202296
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-16-2014
    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.

    Frequently Asked Questions

    What is NDC 0378-7296-53?

    The NDC Packaged Code 0378-7296-53 is assigned to a package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-7296-85) / 1 kit in 1 blister pack of Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 0378-7296 included in the NDC Directory?

    Yes, Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol with product code 0378-7296 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on July 16, 2014 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 0378-7296-53?

    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 0378-7296-53?

    The 11-digit format is 00378729653. 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 4-4-2 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
    4-4-20378-7296-535-4-200378-7296-53