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

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

Package Information

Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol kits is 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. This formulation utilizes a kit delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-7296 and is authorized under FDA application ANDA202296.

Identification & Billing

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
11-Digit Billing Format
00378729653
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
Non-Proprietary Name
Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
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.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202296
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-16-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-7296-53 identifies a specific commercial 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.. 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 Mylan Pharmaceuticals Inc. on July 16, 2014. The current certification is valid through December 31, 2026.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378729653. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 total billable units per package. 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 (4-4-2)
0378-7296-53
11-Digit CMS (5-4-2)
00378-7296-53

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