This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.
NDC Package Code:
54868-4778-0
Package Description:
1 BLISTER PACK in 1 CONTAINER / 1 KIT in 1 BLISTER PACK
Proprietary Name:
Zovia 1/50e-28
Usage Information:
Zovia 1/35E and Zovia 1/50E are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Zovia 1/50E, 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 % of women an unintended pregnancy continuing within the first year of use use at one year (C) Method Typical use (A) Perfect use (B) (1) (2) (3) (4) 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 (A) 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. (B) 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. (C)Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. (D)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. (E) Foams, creams, gels, vaginal suppositories, and vaginal film. (F)Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. (G) With spermicidal cream or jelly. (H) Without spermicides. (I) 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). (J) 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. Chance (D) 85 85 Spermicides (E) 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal (F) 2 Post-ovulation 1 Withdrawal 19 4 Cap (G) Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm (G) 20 6 56 Condom (H) 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 0.05 0.05 88 and Norplant-2) Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.10 100 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. (I) Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. (J)
11-Digit NDC Billing Format:
54868477800
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
RxCUI: 310228 - ethynodiol diacetate 1 MG / ethinyl estradiol 35 MCG Oral TabletRxCUI: 310228 - ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral TabletRxCUI: 310228 - ethinyl estradiol 35 MCG / ethynodiol 1 MG Oral TabletRxCUI: 315096 - ethynodiol diacetate 1 MG / ethinyl estradiol 50 MCG Oral TabletRxCUI: 315096 - ethinyl estradiol 0.05 MG / ethynodiol diacetate 1 MG Oral Tablet Labeler Name:
Physicians Total Care, Inc.
Start Marketing Date:
04-21-2003
Listing Expiration Date:
12-31-2017
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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