NDC 57297-843 Levonorgestrel And Ethinyl Estradiol

The NDC code 57297-843 is assigned by the FDA to the product Levonorgestrel And Ethinyl Estradiol which is product labeled by Lupin Limited. The product's dosage form is . The product is distributed in a single package with assigned NDC code 57297-843-13 3 blister pack in 1 carton / 1 kit in 1 blister pack (57297-843-11). 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.

Levonorgestrel 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. In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18 to 35 years of age during 809 completed 91-day cycles of levonorgestrel and ethinyl estradiol tablets during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) Pregnancy rate of 1.98 per 100 women-years of use.Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.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 anUnintended Pregnancywithin the First Year of Use% of WomenContinuing Useat One Year 3Source: 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 unintended 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 erfectly (both consistently and correctly), the percentage who experience an unintended 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 percentages of women 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 ear. This estimate was lowered slightly (to 85%) to represent the percentage who would ecome 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.6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basalbody temperature in the post-ovulatory phases.7With spermicidal cream or jelly.8Without 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 Food and Drug Administration has declared the following rands 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).10 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.Method (1)Typical Use1 (2)Perfect Use2 (3)(4)Chance 48585Spermicides 526640Periodic abstinence2563      Calendar9      Ovulation method3      Sympto-thermal 62      Post-ovulation1Withdrawal194Cap 7      Parous women402642      Nulliparous women20956Sponge      Parous women402042      Nulliparous women20956Diaphragm 720656Condom 8      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 sterilization0.150.10100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10

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: 238019 - levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet
• RxCUI: 238019 - ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet
• RxCUI: 748797 - inert 1 MG Oral Tablet
• RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
• RxCUI: 751901 - {84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack