Drug Catalog - Product Detail
NORETHINDRONE , USP (HEATHER) TB 0.35MG 3X28
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
68462-0303-29 | GLENMARK PHARMACEUTICALS | 28 | 0.35MG | TABLET |
PACKAGE FILES
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=Structure+of+Norethindrone.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=Structure+of+Norethindrone.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=carton.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=carton.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=day-label-sticker-placement-graphic.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=day-label-sticker-placement-graphic.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=figure1.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=figure1.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=glenmark-log.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=glenmark-log.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=glenmark-logo.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=glenmark-logo.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=pouch.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35b5ddb5-1729-4588-b2a2-ead56d78b6f9&name=pouch.jpg)
Generic Name
NORETHINDRONE
Substance Name
NORETHINDRONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090454
Description
DESCRIPTION Each pale yellow HEATHER tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone, USP daily, and the inactive ingredients include corn starch, lactose monohydrate, magnesium stearate, povidone, talc, D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminium lake. The chemical name for norethindrone, USP is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows: Norethindrone, USP Therapeutic class = oral contraceptive Structure of Norethindrone
How Supplied
HOW SUPPLIED HEATHER (Norethindrone tablets, USP 0.35 mg) are available in 28-tablet dispensers as pale yellow round, flat faced beveled edged, uncoated tablets with ‘303’ debossed on one side and ‘G’ on the other side (NDC 68462-303-29).
Indications & Usage
INDICATIONS AND USAGE 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. 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. Emergency Contraceptive Pill: 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 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 6 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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year Method (1) Typical Use 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 reason. (2) Perfect Use 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) (4) Chance 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% become pregnant within 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 abandoned contraception altogether 85 85 Spermicides Foams, creams, gels, vaginal suppositories, and vaginal film 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases 2 Post-Ovulation 1 Cap With spermicidal cream or jelly Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 20 6 56 Withdrawal 19 4 Condom Without spermicides Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUDs Progesterone T 2.0 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Levonorgestrel Implants (Norplant ® ) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100
Dosage and Administration
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, HEATHER must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions.