NDC Package 68180-897-13 Norethindrone And Ethinyl Estradiol And Ferrous Fumarate

68180-897

Norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg 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 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 implants, 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 an UnintendedPregnancy within the First Year of Use% of WomenContinuing Use at One Year3Method (1)Typical Use1(2)Perfect Use2(3)(4)Chance48585Spermicides526 640Periodic abstinence2563      Calendar 9      Ovulation Method 3      Sympto-thermal6 2      Post-Ovulation 1Cap7      Parous Women402642      Nulliparous Women20 956Sponge      Parous Women402042      Nulliparous Women20 956Diaphragm720 656Withdrawal19 4Condom8      Female (reality)21 556      Male14 361Pill 571      Progestin only0.5      Combined0.1IUD      Progesterone T2.01.581      Copper T 380A0.80.678      LNg 200.10.181Depo-Provera®0.30.370Norplant® and Norplant® 20.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75%9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception10Source: Trussell J, Stewart F, 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 reason2 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 reason3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year4 The percentage of women becoming pregnant noted 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% became pregnant in one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandon contraception altogether5 Foams, creams, gels, vaginal suppositories and vaginal film6 Cervical mucous (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the postovulatory phases7 With spermicidal cream or jelly8 Without spermicides9 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)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

68180089713

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

5 EA

Lupin Pharmaceuticals, Inc.

No

NDA021490

NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

10-04-2011

12-31-2017

I