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  4. NDC Product Code: 0378-7306 Ethynodiol Diacetate And Ethinyl Estradiol

NDC 0378-7306 Ethynodiol Diacetate And Ethinyl Estradiol

Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0378-7306?
  5. Ethynodiol Diacetate And Ethinyl Estradiol Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
0378-7306
Proprietary Name:
Ethynodiol Diacetate And Ethinyl Estradiol
Non-Proprietary Name: [1]
Ethynodiol Diacetate And Ethinyl Estradiol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Mylan Pharmaceuticals Inc.
Labeler Code:
0378
Product Label ID:
563297dc-f27b-46e3-83de-bade17473d62
FDA Application Number: [6]
ANDA204704
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
11-30-2016
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331)
GREEN (C48329)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
252
302
Score:
1

Code Structure Chart

Product Details

What is NDC 0378-7306?

The NDC code 0378-7306 is assigned by the FDA to the product Ethynodiol Diacetate And Ethinyl Estradiol which is a human prescription drug product labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0378-7306-53 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-7306-85) / 1 kit in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Ethynodiol Diacetate And Ethinyl Estradiol?

Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/50 mcg are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as ethynodiol diacetate and ethinyl estradiol tablets, which contain 50 mcg of estrogen, should not be used unless medically indicated.Oral contraceptives are highly effective. Table 1 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 and progestogen implants and injections, 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.Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.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).Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.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.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, in press.1% of women experiencing anunintended pregnancy within the first year of use% of womencontinuing use at one year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.Method(1)Typical useAmong 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.(2)Perfect useAmong 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.(3)(4)Chance 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.8585Spermicides Foams, creams, gels, vaginal suppositories, and vaginal film.26640Periodic abstinence2563   Calendar9   Ovulation method3   Sympto-thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2   Post-ovulation1Withdrawal194Cap With spermicidal cream or jelly.   Parous women402642   Nulliparous women20956Sponge   Parous women402042   Nulliparous women20956Diaphragm 20656Condom Without spermicides.   Female (Reality®)21556   Male14361Pill571   Progestin only0.5   Combined0.1IUD   Progesterone T21.581   Copper T 380A0.80.678   LNg 200.10.181Injection (Depo-Provera) 0.30.370Implant (Norplant and Norplant-2) 0.050.0588Female sterilization0.50.5100Male sterilization 0.150.1100

Which are Ethynodiol Diacetate And Ethinyl Estradiol UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Ethynodiol Diacetate And Ethinyl Estradiol Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Ethynodiol Diacetate And Ethinyl Estradiol?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 315096 - ethynodiol diacetate 1 MG / ethinyl estradiol 50 MCG Oral Tablet
  • RxCUI: 315096 - ethinyl estradiol 0.05 MG / ethynodiol diacetate 1 MG Oral Tablet
  • RxCUI: 315096 - ethinyl estradiol 50 MCG / ethynodiol diacetate 1 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet

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Patient Education

Estrogen and Progestin (Oral Contraceptives)


Oral contraceptives (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Oral contraceptives are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases. Some brands of oral contraceptives are also used to treat acne in certain patients. Oral contraceptives treat acne by decreasing the amounts of certain natural substances that can cause acne. Some oral contraceptives (Beyaz, Yaz) are also used to relieve the symptoms of premenstrual dysphoric disorder (physical and emotional symptoms that occur before the menstrual period each month) in women who have chosen to use an oral contraceptive to prevent pregnancy.
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* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".