Nortrel 7/7/7 Kit
NDC Package 0555-9012-58

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

6 EA

Norethindrone And Ethinyl Estradiol

Kit - A packaged collection of related material.

Nortrel® 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) is 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 1 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 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One Year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. Method (1) Typical Use 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)Perfect Use 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)(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 abstinence 2563 Calendar 9 Ovulation Method 3 Sympto-Thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post-Ovulation1Cap With spermicidal cream or jelly. Parous Women 402642 Nulliparous Women 20956Sponge Parous Women 402042 Nulliparous Women 20956Diaphragm 20656Withdrawal 194Condom Without spermicides.  Female (Reality®) 21556 Male 14361Pill 571 Progestin Only 0.5 Combined 0.1IUD Progesterone T 2.01.581 Copper T380A 0.80.678 LNg 20 0.10.181Depo-Provera®0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization 0.50.5100Male Sterilization 0.150.10100Adapted from Hatcher et al., 1998, Ref. #1.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.Nortrel 7/7/7 has not been studied for and is not indicated for use in emergency contraception.

Teva Pharmaceuticals Usa, Inc.

Human Prescription Drug

ANDA075478

ANDA - A product marketed under an approved Abbreviated New Drug Application.

01-02-2003

12-31-2027

N

No