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
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 aluminium 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) is available in cartons (NDC 68462-303-29) of 3 blisters (NDC 68462-303-84) each containing 28 pale yellow, round, flat faced, beveled edged, uncoated tablets with ‘303’ debossed on one side and ‘G’ on the other side.
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 Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 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 (2) Perfect Use (3) (4) Chance 85 85 Spermicides 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 2 Post-Ovulation 1 Cap 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 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.
