NDC 51862-514 Desogestrel And Ethinyl Estradiol

The NDC code 51862-514 is assigned by the FDA to the product Desogestrel And Ethinyl Estradiol which is a human prescription drug product labeled by Mayne Pharma Inc.. The product's dosage form is kit. The product is distributed in 4 packages with assigned NDC codes 51862-514-01 1 blister pack in 1 packet / 1 kit in 1 blister pack, 51862-514-02 1 blister pack in 1 carton / 1 kit in 1 blister pack, 51862-514-03 3 blister pack in 1 carton / 1 kit in 1 blister pack, 51862-514-06 6 blister pack in 1 carton / 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.

Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly.TABLE I: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 Year3MethodTypical Use1Perfect Use2(1)(2)(3)(4)Chance48585Spermicides526640Periodic abstinence2563Calendar9Ovulation Method3Sympto-Thermal62Post-Ovulation1Withdrawal194Cap7Parous Women402642Nulliparous Women20956SpongeParous Women402042Nulliparous Women20956Diaphragm720656Condom8Female (Reality)®21556Male14361Pill571Progestin Only0.5Combined0.1IUDProgesterone T2.01.581Copper T380A0.80.678LNg 200.10.181Depo-Provera0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10Source: 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, 1998.1 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.2 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.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4 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.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA 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 4 yellow pills).10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.Desogestrel and ethinyl estradiol tablets have not been studied for and is not indicated for use in emergency contraception.

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: 240707 - desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet
• RxCUI: 748797 - inert 1 MG Oral Tablet
• RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
• RxCUI: 749848 - {21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
• RxCUI: 749848 - Desogest-Eth estra 0.15-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack