Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Kit — NDC 0378-7303-53 (Billing 00378-7303-53)
This is a package of Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Kit from Mylan Pharmaceuticals Inc., marketed since Jul 2022 and currently FDA-listed; retail pharmacies pay about $0.7879 per unit (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 030493
- GCN: 68105
- HICL (First Databank): 001454
- AHFS class code: 68:12.00.00
- RxCUI (RxNorm): 259176
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Iron bivalent, oral preparations class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and norethindrone (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work mainly by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.788 | — |
| Medicaid paysCMS SDUD · 12 mo | $1.26 | — |
| Medicare drug plans payPart D · Q2 2026 | $0.3382 | — |
Where does this data come from?
- CMS NADAC weekly file · file of Aug 19, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00378-7303-53 You're viewing this Main listing | 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 9 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 5 TABLET | 2022-07-27 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tarina Fe 1/20 EQ 50102-0228-23 | Afaxys | 3 pouches | $0.129 | AB | Availability likely | save 84% |
| HAILEY Fe 1/20 68462-0419-29 | Glenmark | 1 kit | $0.129 | AB | Availability likely | save 84% |
| Junel Fe 28 Day 00555-9026-58 | Teva | 6 pouches | $0.129 | AB | Availability likely | save 84% |
| Hailey Fe 1.5/30 68462-0503-29 | Glenmark | 3 pouches | $0.142 | AB | Availability likely | save 82% |
| Junel Fe 28 Day 00555-9028-58 | Teva | 6 pouches | $0.142 | AB | Availability likely | save 82% |
| Junel Fe 24 00093-5328-62 | Teva | 3 pouches | $0.175 | AB | Availability likely | save 78% |
| Tarina 24 Fe 50102-0224-23 | Afaxys | 3 pouches | $0.175 | AB | Availability likely | save 78% |
| Finzala 00093-8210-62 | Teva | 12 tablets | $0.304 | AB | Availability likely | save 61% |
| Charlotte 24Fe 68462-0852-29 | Glenmark | 1 kit | $0.304 | AB | Availability likely | save 61% |
| norethindrone acetate and ethinyl estradiol and ferrous fumarate 68462-0376-29 | Glenmark | 1 kit | $0.422 | AB | FDA listed | save 46% |
| Melodetta 24 Fe 69238-1031-07 | Amneal | 1 kit | $0.422 | — | FDA listed | save 46% |
| Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumaratethis 00378-7303-53 | Mylan | 21 tablets | $0.788 | AB | Availability likely | — |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate 68462-0849-29 | Glenmark | 24 capsules | $0.962 | AB | Availability likely | +22% |
| Loestrin Fe 28 Day 51285-0125-70 | Teva | 5 pouches | $8.232 | AB | Availability likely | +945% |
| Junel Fe 28 Day 50090-3237-00 | A-S | 1 kit | — | AB | FDA listed | — |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate 60219-1031-07 | Amneal | 1 kit | — | — | FDA listed | — |
| Aurovela 24 Fe 65862-0934-58 | Aurobindo | 5 pouches | — | AB | FDA listed | — |
| Aurovela Fe 1/20 65862-0940-58 | Aurobindo | 5 pouches | — | AB | FDA listed | — |
| AUROVELA Fe 65862-0941-58 | Aurobindo | 5 pouches | — | AB | FDA listed | — |
| Junel Fe 28 Day 50090-3122-00 | A-S | 6 pouches | — | AB | FDA listed | — |
| Junel Fe 28 Day 63629-5628-01 | Bryant | 6 pouches | — | AB | FDA listed | — |
| Oshih 59651-0504-88 | Aurobindo | 3 pouches | — | — | FDA listed | — |
| Loestrin Fe 28 Day 51285-0128-70 | Teva | 5 pouches | — | AB | FDA listed | — |
| Junel Fe 28 Day 72789-0450-79 | PD-Rx | 1 pouch | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Aug 19, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: Cigarette smoking increases the risk of serious cardiovascular side effects from combined oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including norethindrone acetate and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke.
🎯 Indications and 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 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. Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. è Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. ð Source: Trussell J, The Essentials of Contraception.
In Hatcher RA, Trussell J, Stewart F, Cates W, Stweart GK, Kowel 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 ‡ 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 Symptothermal #Þ 2 Post-ovulation 1 Cap ß Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm ß 20 6 56 Withdrawal 19 4 Condom à Female (Reality ® ) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only
0.5 Combined
0.1IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNG 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Norplant ® and Norplant-2 ® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 ‡ Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. * 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. † 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. § The percentages 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. ¶ Foams, creams, gels, vaginal suppositories, and vaginal film. #Þ Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. ß With spermicidal cream or jelly. à Without spermicid… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and 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, norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be taken exactly as directed and at intervals not exceeding 24 hours. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets provide a continuous administration regimen.
These tablets are to be taken in the following order: one white to off white each day for five days, then light purple tablet each day for seven days, followed by one purple tablet each day for nine days, and then one brown non-hormone tablet each day for seven days. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen and do not serve any therapeutic purpose. There is no need for the patient to count days between cycles because there are no “off-tablet days”.
A. Sunday-Start Regimen: The patient begins taking the first white to off white tablet from the top row of the blister (labeled Sunday) on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first white to off white tablet is taken on the same day.
The patient takes one white to off white tablet daily for 5 days. The last purple tablet in the blister will be taken on a Saturday. Upon completion of all 21 tablets, and without interruption, the patient takes one brown tablet daily for 7 days.
Upon completion of this first course of tablets, the patient begins a second course of 28-day tablets, without interruption, the next day (Sunday), starting with the Sunday white to off white tablet in the top row. Adhering to this regimen of one tablet daily for 21 days, followed without interruption by one brown tablet daily for 7 days, the patient will start all subsequent cycles on a Sunday. B.
Day-1 Start Regimen: The first day of menstrual flow is Day 1. The patient places the self-adhesive day label strip that corresponds to her starting day over the preprinted days on the tablet blister. She starts taking one tablet daily, beginning with the first white to off white tablet in the top row.
After the last purple tablet (at the end of the third row) has been taken, the patient will then take the brown tablets for a week (7 days). For all subsequent cycles, the patient begins a new 28 tablet regimen on the eighth day after taking her last purple tablet, again starting with the first tablet in the top row after placing the appropriate day label strip over the preprinted days on the tablet blister. Following this regimen of 21 tablets and 7 brown tablets, the patient will start all subsequent cycles on the same day of the week as the first course.
Tablets should be taken regularly at the same time each day and can be taken without regard to meals. It should be stressed that efficacy of medication depends on strict adherence to the dosage schedule. S… [Excerpted — this section continues on DailyMed.]
⛔ 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 prior pill use • Hepatic adenomas or carcinomas • Known or suspected pregnancy • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).
⚠️ 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 of the relative risk of a disease, namely, a ratio of the incidence of a disease among combined oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between combined oral contraceptive users and nonusers.
The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from References 8 and 9 with the author's permission). For further information, the reader is referred to a text on epidemiological methods. 1.
Thromboembolic Disorders and Other Vascular Problems a. Myocardial infarction An increased risk of myocardial infarction has been attributed to combined oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes.
The relative risk of heart attack for current combined oral contraceptive users has been estimated to be two to six. The risk is very low under the age of 30. Smoking in combination with combined oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases.
Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 (Figure 3) among women who use combined oral contraceptives. Figure 3. Circulatory Disease Mortality Rates per 100,000 Woman Years by Age, Smoking Status and Combined Oral Contraceptive Use Adapted from P.M.
Layde and V. Beral Combined oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism.
Combined oral contraceptives have been shown to increase blood pressure among users (see Section 10 in WARNINGS ). Similar effects on risk factors have been associated with an increased risk of heart disease. Combined oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Figure 3. Circulatory Disease Mortality Rates per 100,000 Woman Years by Age, Smoking Status and Oral Contraceptive Use b. Thromboembolism An increased risk of thromboembolic and thrombotic disease associated with the use of combined oral contraceptives is well established.
Case control studies have found the relative risk of users compared to nonusers to be 3 for the… [Excerpted — this section continues on DailyMed.]
🤒 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 • Cholestatic jaundice • Migraine • Rash (allergic) • Mental depression • Mood swings • Reduced tolerance to carbohydrates • Vaginal candidiasis • Change in corneal curvature (steepening) • Intolerance to contact lenses The following adverse reactions have been reported in users of combined oral contraceptives and the association has been neither confirmed nor refuted: • Pre-menstrual syndrome • Cataracts • Changes in appetite • Cystitis-like syndrome • Headache • Nervousness • Dizziness • Hirsutism • Loss of scalp hair • Erythema multiforme • Erythema nodosum • Hemorrhagic eruption • Vaginitis • Porphyria • Impaired renal function • Hemolytic uremic syndrome • Budd-Chiari syndrome • Acne • Changes in libido • Colitis Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 4).
Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 4). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use.
Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 4. Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
Figure 4. Risk of Breast Cancer with Combined Oral Contraceptive Use
🆘 Overdosage ▾
OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of combined oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. NON-CONTRACEPTIVE HEALTH BENEFITS The following non-contraceptive health benefits related to the use of combined oral contraceptives are supported by epidemiological studies which largely utilized combined oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.
Effects on menses: • Increased menstrual cycle regularity • Decreased blood loss and decreased incidence of iron deficiency anemia • Decreased incidence of dysmenorrhea Effects related to inhibition of ovulation: • Decreased incidence of functional ovarian cysts • Decreased incidence of ectopic pregnancies Effects from long-term use: • Decreased incidence of fibroadenomas and fibrocystic disease of the breast • Decreased incidence of acute pelvic inflammatory disease • Decreased incidence of endometrial cancer Decreased incidence of ovarian cancer
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY ORAL CONTRACEPTION Combined oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). In vitro and animal studies have shown that norethindrone combines high progestational activity with low intrinsic androgenicity.
In humans, norethindrone acetate in combination with ethinyl estradiol does not counteract estrogen-induced increases in sex hormone binding globulin (SHBG). Following multiple-dose administration of norethindrone acetate and ethinyl estradiol tablets, serum SHBG concentrations increase two- to three-fold and free testosterone concentrations decrease by 47% to 64%, indicating minimal androgenic activity. ACNE Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production.
While the combination of norethindrone acetate and ethinyl estradiol increases sex hormone binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established. Pharmacokinetics Absorption Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, since the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone.
Norethindrone acetate and ethinyl estradiol are rapidly absorbed, with maximum plasma concentrations of norethindrone and ethinyl estradiol occurring 1 to 2 hours post-dose. Both are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and 43% for ethinyl estradiol. Administration of norethindrone acetate and ethinyl estradiol with a high fat meal decreases rate, but not extent, of ethinyl estradiol absorption.
The extent of norethindrone absorption is increased by 27% following administration with food. Plasma concentrations of norethindrone and ethinyl estradiol following chronic administration of norethindrone acetate and ethinyl estradiol tablets to 17 women are shown below (Figure 1). Mean steady-state concentrations of norethindrone for the 1/20, 1/30, and 1/35 tablet strengths increased as ethinyl estradiol dose increased over the 21-day dose regimen, due to dose-dependent effects of ethinyl estradiol on serum SHBG concentrations (Table 1).
Mean steady-state plasma concentrations of ethinyl estradiol for the 1/20, 1/30, and 1/35 tablet strengths were proportional to ethinyl estradiol dose (Table 1). Figure 1. Mean Steady-State Plasma Ethinyl Estradiol and Norethindrone Concentrations Following Chronic Administration of Norethindrone Acetate and Ethinyl Estradiol Tablets Table 1.
Mean (SD) Steady-State Pharmacokinetic Parameters Following Chronic Administration of Norethindrone Acetate and Ethinyl Estradiol Tablets * Norethindrone Acetate / Ethinyl Estradiol Dose Cycle Day Cmax AUC CL/F SHBG † Norethindrone mg/µg ng/mL ng·hr/mL mL/min nmol/L 1/20 5 10.8 (3.9) 81.1 (28.5) 220 (137) 120 (33) 1/30 12 12.7 (4.1) 102 (32) 166 (85) 139 (42) 1/35 21 12.7 (4.1) 109 (32) 152 (73) 163 (40) Ethinyl Estradiol mg/µg pg/mL pg·hr/mL mL/min nmol/L 1/20 5 61.0 (16.8) 661 (190) 549 (171) 1/30 12 92.4 (26.9) 973 (293) 546 (199) 1/35 21 113 (44) 1149 (372) 568 (219) * Cmax = Maximum plasma concentration; AUC (0-24) = Area under the plasma concentration-time curve over the dosing interval; CL/F = Apparent oral clearance † Mean (SD) baseline value = 55 (29) nmol/L No age-related differences were seen in plasma concentrations of ethinyl estradiol and norethindrone following administration of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets to 119 postmenarchal women ages 15 t… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets are available in blister packs each containing 28 tablets. The first five white to off white tablets each contain 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol; the next seven light purple tablets each contain 1 mg of norethindrone acetate and 30 mcg of ethinyl estradiol; the next nine purple tablets each contain 1 mg of norethindrone acetate and 35 mcg of ethinyl estradiol; and the last seven (brown) tablets each contain 75 mg ferrous fumarate.
Carton of 3 tri-laminated aluminium pouches (NDC 0378-7303-53), Carton of 6 tri-laminated aluminium pouches (NDC 0378-7303-56) each pouch containing blister of 28 tablets. Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Store tablets in blister sleeve when not in use.
Keep this and all medication out of the reach of children. REFERENCES AVAILABLE UPON REQUEST The brands listed are trademarks of their respective owners.
📋 Description ▾
DESCRIPTION Norethindrone acetate and ethinyl estradiol tablets are graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets provide for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose.
Each white to off white tablet contains 1 mg norethindrone acetate [(17 alpha)- 17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)- 19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light purple tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each purple tablet contains 1 mg norethindrone acetate, 35 mcg ethinyl estradiol. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 20 mcg) also contain: Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium.
Norethindrone acetate and ethinyl estradiol tablets (1 mg and 30 mcg) also contain: Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine.
Norethindrone acetate and ethinyl estradiol tablets (1 mg and 35 mcg) also contain: Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine.
The structural formulas are as follows: Each brown tablet contains ferrous fumarate, microcrystalline cellulose, lactose monohydrate, polyvinyl pyrrolidone K-90, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Each norethindrone acetate and ethinyl estradiol tablet and ferrous fumarate tablet blister contains five white to off white tablets, seven light purple tablets, nine purple tablets, and seven brown tablets. These tablets are to be taken in the following order: one white to off white each day for five days, then light purple tablet each day for seven days, followed by one purple tablet each day for nine days, and then one brown tablet each day for seven days.
Structural Formula
⚠️ Precautions ▾
PRECAUTIONS 1. Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 2.
Physical Examination and Follow-Up It is good medical practice for all women to have annual history and physical examinations, including women using combined oral contraceptives. The physical examination, however, may be deferred until after initiation of combined oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests.
In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. 3.
Lipid Disorders Women who are being treated for hyperlipidemia should be followed closely if they elect to use combined oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult. 4.
Liver Function If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function. 5.
Fluid Retention Combined oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. 6.
Emotional Disorders Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree. 7. Contact Lenses Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
8. Drug Interactions Effects of Other Drugs on Combined Oral Contraceptives Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin. A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin.
Anticonvulsants: Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine, have been shown to increase the metabolism of ethinyl estradiol and/or norethindrone, which could result in a reduction in contraceptive effectiveness. Antibiotics: Pregnancy while taking combined oral contraceptives has been reported when the combined oral contraceptives were administered with antimicrobials such as ampicillin, tetracycline, and griseofulvin. However, clinical pharmacokinetic studies have not demonstrated any consistent effect of antibiotics (other than rifampin) on plasma concentrations of synthetic steroids.
Atorvastatin: Coadministration of atorvastatin and an combined oral contraceptive increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%, respectively. St. John’s Wort: Herbal products containing St.
John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of combined oral contraceptives. This may also result in breakthrough bleeding. Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors Significant changes (increase or decrease) in the plasma concentrations of estrogen and progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or incr… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
Pharmacokinetics
📄 Patient Package Insert ▾
BRIEF SUMMARY PATIENT PACKAGE INSERT Do not use norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets (like all oral contraceptives) are intended to prevent pregnancy.
It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases. Combined oral contraceptives, also known as “birth control pills” or “the pill”, are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.
For most women combined oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets may also be taken to treat moderate acne in females who are at least 15 years of age, have started having menstrual periods, are able to use the pill and want the pill for birth control, plan to stay on the pill for at least 6 months, and have not improved with acne medicines that are put on the skin.
For the majority of women, combined oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you: • Smoke • Have high blood pressure, diabetes, high cholesterol, migraine headaches • Have or have had blood clots in your arm, legs, lungs, or eyes, clotting disorders, heart attack, heart problems, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors. • Are receiving Hepatitis C medication You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.
Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea, vomiting, and breakthrough bleeding, may subside within the first three months of use.
The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill: 1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris), or other organs of the body.
As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. 2. Liver tumors, which may rupture and cause severe bleeding.
A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.
3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped. The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills.
Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, may decrease combined ora… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0378-7303-53 Rx only Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets* 1 mg/20 mcg 1 mg/30 mcg 1 mg/35 mcg *Ferrous fumarate tablets are not USP for dissolution and assay. Pharmacist: Each pouch contains Detailed Patient Labeling and a carrier sleeve. The Detailed Patient Labeling and the carrier sleeve should be included with each package dispensed to the patient.
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 28-Day Regimen An Oral Contraceptive with Acne Indication 3 pouches each containing 28 tablets 3s carton
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