NDC Package 0093-8073-16 Kelnor 1/50

6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (0093-8073-28)

0093-8073

Ethynodiol Diacetate And Ethinyl Estradiol

Kelnor 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Kelnor 1/50, 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.  % of women experiencing anunintended pregnancywithin the first year of use % of womencontinuing use at one yearAmong 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) ChanceThe 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. 85 85  SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film. 26 6 40 Periodic abstinence  25  63  Calendar   9   Ovulation method   3   Sympto-thermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.  2   Post-ovulation   1  Withdrawal  19 4  CapWith spermicidal cream or jelly.     Parous women  40 26 42  Nulliparous women  20 9 56 Sponge      Parous women  40 20 42  Nulliparous women  20 9 56 Diaphragm 20 6 56 CondomWithout spermicides.     Female (Reality®)  21 5 56  Male  14 3 61 Pill  5  71  Progestin only   0.5   Combined   0.1  IUD      Progesterone T  2.0 1.5 81  Copper T 380A  0.8 0.6 78  LNg 20  0.1 0.1 81 Injection (Depo-Provera®)  0.3 0.3 70 Implant (Norplant® and Norplant-2®) 0.05 0.05 88 Female sterilization  0.5 0.5 100 Male sterilization  0.15 0.1 100 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

00093807316

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

6 EA

Human Prescription Drug

Teva Pharmaceuticals Usa, Inc.

Kit - A packaged collection of related material.

No

ANDA072723

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

03-01-2018

12-31-2024

N