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:
68462-637-29
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK
Proprietary Name:
Levonorgestrel And Ethinyl Estradiol
Non-Proprietary Name:
Levonorgestrel And Ethinyl Estradiol
Substance Name:
Ethinyl Estradiol; Levonorgestrel
Usage Information:
Levonorgestrel and ethinyl estradiol tablets USP 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 for pregnancy prevention. 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, depend 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 Unintended Pregnancy within the First Year of Use% of WomenContinuing Use at One Year3Method (1)Typical Use1 (2)Perfect Use2 (3)(4)Chance48585Spermicides526640Periodic abstinence2563 Calendar 9 Ovulation Method3 Sympto-Thermal62 Post-Ovulation1Cap7 Parous Women402642 Nulliparous Women20956Sponge Parous Women402042 Nulliparous Women20956Diaphragm720656Withdrawal194Condom8 Female (RealityTM)21556 Male14361Pill571 Progestin only0.5 Combined0.1IUD Progesterone T2.01.581 Copper T380A0.80.678 LNg 200.10.181Depo-Provera®0.30.370LevonorgestrelImplants (Norplant®)0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel 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 reason.2.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.3.Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4.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.5.Foams, creams, gels, vaginal suppositories, and vaginal film.6.Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7.With spermicidal cream or jelly.8.Without spermicides.9.The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 0.05 mg of ethinyl estradiol and 0.50 mg of norgestrel 1 dose is 2 tablets; for tablets containing 0.02 mg of ethinyl estradiol and 0.1 mg of levonorgestrel 1 dose is 5 tablets; for tablets containing 0.03 mg of ethinyl estradiol and 0.15 mg of levonorgestrel 1 dose is 4 tablets.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 6 months of age.
11-Digit NDC Billing Format:
68462063729
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: 722152 - ethinyl estradiol 20 MCG / levonorgestrel 90 MCG Oral TabletRxCUI: 722152 - ethinyl estradiol 0.02 MG / levonorgestrel 0.09 MG Oral TabletRxCUI: 751553 - {28 (ethinyl estradiol 0.02 MG / levonorgestrel 0.09 MG Oral Tablet) } PackRxCUI: 751553 - Eth estra-Levonorgest 0.02-0.09 MG (28) Oral Tablet 28 Day Pack Product Type:
Human Prescription Drug
Labeler Name:
Glenmark Pharmaceuticals Inc., Usa
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
FDA Application Number:
ANDA202791
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-09-2015
Listing Expiration Date:
12-31-2025
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.
* Please review the disclaimer below.