Loestrin 24 Fe
NDC 54868-6100

The NDC code 54868-6100 is assigned by the FDA to the product Loestrin 24 Fe. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-6100-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

Loestrin 24 Fe is 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 2 lists the typical unplanned pregnancy rates for users of combination 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 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 WomenUnintendedthe First YearExperiencing anPregnancy withof Use% of Women Continuing Useat One Year*Method(1)Typical Use†(2)Perfect Use‡(3)(4)Chance§8585Spermicides¶26640Periodic abstinence2563  Calendar9  Ovulation Method3  Sympto-thermal#2  Post-Ovulation1CapÞ  Parous Women402642  Nulliparous Women20956Sponge  Parous Women402042  Nulliparous Women20956DiaphragmÞ20656Withdrawal194Condomß  Female (reality)21556  Male14361Pill571  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% àLactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception èSource: 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.*  Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year †  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 ‡  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 §  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 altogether ¶  Foams, creams, gels, vaginal suppositories and vaginal film #  Cervical mucous (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the postovulatory phases Þ  With spermicidal cream or jelly ß  Without spermicides à  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)è  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 Clinical Studies In a clinical study, 743 women, 18 to 45 years of age, were treated with Loestrin 24 Fe for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for Loestrin 24 Fe was 1.82.