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:
0378-7306-53
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-7306-85) / 1 KIT in 1 BLISTER PACK
Proprietary Name:
Ethynodiol Diacetate And Ethinyl Estradiol
Non-Proprietary Name:
Ethynodiol Diacetate And Ethinyl Estradiol
Usage Information:
Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/50 mcg 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 ethynodiol diacetate and ethinyl estradiol tablets, 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.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% of women experiencing anunintended pregnancy within the first year of use% of womencontinuing use at one year Among 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)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 abstinence2563 Calendar9 Ovulation method3 Sympto-thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2 Post-ovulation1Withdrawal194Cap With spermicidal cream or jelly. Parous women402642 Nulliparous women20956Sponge Parous women402042 Nulliparous women20956Diaphragm 20656Condom Without spermicides. Female (Reality®)21556 Male14361Pill571 Progestin only0.5 Combined0.1IUD Progesterone T21.581 Copper T 380A0.80.678 LNg 200.10.181Injection (Depo-Provera) 0.30.370Implant (Norplant and Norplant-2) 0.050.0588Female sterilization0.50.5100Male sterilization 0.150.1100
11-Digit NDC Billing Format:
00378730653
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
RxCUI: 315096 - ethynodiol diacetate 1 MG / ethinyl estradiol 50 MCG Oral TabletRxCUI: 315096 - ethinyl estradiol 0.05 MG / ethynodiol diacetate 1 MG Oral TabletRxCUI: 315096 - ethinyl estradiol 50 MCG / ethynodiol diacetate 1 MG Oral TabletRxCUI: 748797 - inert 1 MG Oral TabletRxCUI: 748797 - inert ingredients 1 MG Oral Tablet Product Type:
Human Prescription Drug
Labeler Name:
Mylan Pharmaceuticals Inc.
Dosage Form:
Kit - A packaged collection of related material.
FDA Application Number:
ANDA204704
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
11-30-2016
Listing Expiration Date:
12-31-2024
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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