Norethindrone .35 mg/1

Norethindrone · TABLET · Glenmark Pharmaceuticals Inc., USA

No Recall History

Plain English

Norethindrone is a tablet containing norethindrone at .35 mg/1, taken oral. Manufactured by Glenmark Pharmaceuticals Inc., USA.

Key Facts

Brand Name: Norethindrone
Generic Name: Norethindrone
NDC Code (Product): 68462-305
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Strength: .35 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA091209
Drug Class: Progestin [EPC]
Marketing Start: 11/03/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea431 reports

headache427 reports

hot flush390 reports

fatigue339 reports

drug ineffective310 reports

off label use292 reports

pain287 reports

vaginal haemorrhage275 reports

abdominal pain270 reports

arthralgia228 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 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, depends upon the reliability with which they are used. Correct and consistent use of methods…

Dosage & Administration

DOSAGE AND ADMINISTRATION The tablet blister has been designed to make norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing on the tablet blister above the first row of tablets. Note: Each tablet blister has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different day label strips have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day-1 Start regimen. If the patient is using the Day-1 Start regimen, she should place the self-adhesive day label strip that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 28-Day Dosage Regimen To achieve maximum contraceptive effectiveness, norethi…

Warnings

WARNINGS The use of combined oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing combined oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used combined oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the combined oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure…

Contraindications

CONTRAINDICATIONS Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are contraindicated in females who are known to have or develop the following conditions: • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 • Have cerebrovascular disease • Have coronary artery disease • Have current or history of deep vein thrombosis or pulmonary embolism • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart • Have inherited or acquired hypercoagulopathies • Have uncontrolled hypertension or hypertension with vascular disease • Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches • Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or with vascular disease or end-organ damage, or diabetes mellitus of > 20 years duration • Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia • Undiagnosed abnormal genital bleeding • Cholestatic jaundice of pregnancy or jaundice with…

Adverse Reactions

ADVERSE REACTIONS An increased risk of the following serious adverse reactions has been associated with the use of combined oral contraceptives (see WARNINGS section): • Thrombophlebitis • Arterial thromboembolism • Pulmonary embolism • Myocardial infarction • Cerebral hemorrhage • Cerebral thrombosis • Hypertension • Gallbladder disease • Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of combined oral contraceptives, although additional confirmatory studies are needed: • Mesenteric thrombosis • Retinal thrombosis The following adverse reactions have been reported in patients receiving combined oral contraceptives and are believed to be drug-related: • Nausea • Vomiting • Gastrointestinal symptoms (such as abdominal cramps and bloating) • Breakthrough bleeding • Spotting • Change in menstrual flow • Amenorrhea • Temporary infertility after discontinuation of treatment • Edema • Melasma which may persist • Breast changes: tenderness, enlargement, secretion • Change in weight (increase or decrease) • Change in cervical erosion and secretion • Diminution in lactation when given immediately postpartum • Cholestat…

Frequently Asked Questions

What is Norethindrone used for?

Norethindrone contains Norethindrone. It is a tablet taken oral. Consult your doctor for specific uses.

Is Norethindrone a controlled substance?

Norethindrone is not classified as a controlled substance by the DEA.

What is the generic name for Norethindrone?

The generic name for Norethindrone is Norethindrone. There are 12 other brand versions of Norethindrone.

What is the NDC code for Norethindrone .35 mg/1?

The NDC (National Drug Code) for Norethindrone .35 mg/1 is 68462-305, listed by Glenmark Pharmaceuticals Inc., USA.

Product NDC

68462-305

Package NDC

68462-305-29

Other Norethindrone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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