Prescription medicine
Ethinyl estradiol and norethindrone Brand names: Femlyv, Nortrel, Alyacen, Junel, Blisovi; first approved as Loestrin Fe 1.5/30
Ethinyl estradiol and norethindrone (Nortrel) is a prescription medicine with an FDA approval on record since 1973. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $0.181 per microgestin 21 1-20 tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $7.04 per unit (Femlyv 1 mg-0.02 mg ODT).
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and norethindrone FDA label on DailyMed (effective November 18, 2025, Lupin Pharmaceuticals, Inc.); the NDA 17355 record on Drugs@FDA; every ethinyl estradiol and norethindrone label on DailyMed.
Highlights of the record
FDA label of November 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS.
Cigarette smoking increases the risk of serious cardiovascular events from combination 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 Blisovi Fe 1/20, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS). BRIEF SUMMARY PATIENT PACKAGE INSERT Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. 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, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy. For the majority of women, oral contraceptives can be taken safely. […]
Used for
From the label: indications and usageBlisovi Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Forms and strengths
- 0.5 mg
- 1 mg
- 1.5 mg
- 0.0025 mg / 0.5 mg
- 0.005 mg / 1 mg
- 0.02 mg / 1 mg
- 0.03 mg / 1.5 mg
- 1 mg / 0.02 mg
- 1 mg / 0.035 mg
- 1.5 mg / 0.03 mg
Kit; tablet; film-coated tablet.
On the market
- Earliest approval on file
- April 30, 1973 Loestrin Fe 1.5/30, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 118 first January 29, 1987; 70 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 18 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 2, 2029 Lo Loestrin Fe tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.181 per tablet Microgestin 21 1-20 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2013 0 Class I among all firms' recalls; latest May 27, 2026
- FAERS reports
- 3,631 through July 30, 2026
What is ethinyl estradiol and norethindrone used for?
From the label: indications and usageBlisovi Fe 1/20 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. Table I 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. […]
Conditions named in the indications of ethinyl estradiol and norethindrone's FDA labels, with every medicine labeled for each:
From other ethinyl estradiol and norethindrone labelsBirth control: INDICATIONS AND USAGE Blisovi Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Osteoporosis and Menopause symptoms: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis
Acne: Tri-Legest ® Fe is 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 …
Source: FDA drug label (Blisovi Fe 1/20), Lupin Pharmaceuticals, Inc., effective November 18, 2025 (SPL set ddbb5d60-cacf-4672-935d-86d668287992), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and norethindrone (Nortrel)?
The FDA approved the first generic ethinyl estradiol and norethindrone on January 29, 1987. 118 generic applications are approved; 70 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists ethinyl estradiol and norethindrone from 18 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Lo Loestrin Fe tablets, the last expiring on February 2, 2029; a patent listed only for Femlyv tablets runs to June 24, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1973 earliest approval on file
- 1987 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ethinyl estradiol and norethindrone (Nortrel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.181 per Microgestin 21 1-20 tablet, up 5% from $0.172 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Microgestin 21 1-20 tablet (generic)
- Femlyv 1 mg-0.02 mg ODT (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alyacen 1-35 28 tablet | Generic | $0.203 per tablet | $6.08 | -10% |
| Alyacen 7-7-7-28 tablet | Generic | $0.216 per tablet | $6.48 | -22% |
| Aranelle 28 tablet | Generic | $0.630 per tablet | $18.90 | +9% |
| Aurovela 1 mg-20 mcg tablet | Generic | $0.181 per tablet | $5.44 | +5% |
| Aurovela 21 1.5-30 tablet | Generic | $0.336 per tablet | $10.07 | -11% |
| Balziva 28 tablet | Generic | $0.330 per tablet | $9.89 | no change |
| Blisovi 24 fe tablet | Generic | $0.175 per tablet | $5.24 | -15% |
| Blisovi fe 1-20 tablet | Generic | $0.129 per tablet | $3.86 | -12% |
| Blisovi fe 1.5-30 tablet | Generic | $0.142 per tablet | $4.26 | -8% |
| Briellyn 0.4 mg-0.035 mg tablet | Generic | $0.330 per tablet | $9.89 | n/a |
| Dasetta 1-35-28 tablet | Generic | $0.203 per tablet | $6.08 | -10% |
| Dasetta 7/7/7-28 tablet | Generic | $0.216 per tablet | $6.48 | -22% |
| Fyavolv 0.5 mg-2.5 mcg tablet | Generic | $0.913 per tablet | $27.38 | -12% |
| Fyavolv 1 mg-5 mcg tablet | Generic | $0.580 per tablet | $17.40 | -45% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ethinyl estradiol and norethindrone been recalled?
The FDA's Enforcement Report lists 8 recalls naming ethinyl estradiol and norethindrone since 2013: 0 Class I (the most serious), 4 Class II, 4 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 27, 2026 | Class II | Glenmark Pharmaceuticals Inc., USA | Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. |
| January 25, 2024 | Class III | Teva Pharmaceuticals USA, Inc | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| December 26, 2019 | Class II | Lupin Pharmaceuticals Inc. | Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack. |
| July 2, 2019 | Class II | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study. |
| January 30, 2017 | Class III | Mylan Pharmaceuticals Inc. | Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint … |
| March 15, 2013 | Class III | Teva Pharmaceuticals USA, Inc. | Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ethinyl estradiol and norethindrone label say about other medicines?
The ethinyl estradiol and norethindrone label names 15 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. |
| Ascorbic acid | drug interactions | Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. |
| Atorvastatin | drug interactions | Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. |
| Bosentan | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. |
| Carbamazepine | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. |
| Felbamate | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. |
| Griseofulvin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. |
| Itraconazole | drug interactions | CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone concentrations. |
| Ketoconazole | drug interactions | CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone concentrations. |
| Lamotrigine | drug interactions | COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. |
| Nicotine | warnings and precautions | In addition to cigarettes, use of other nicotine-containing products – including cigars, smokeless tobacco, hookah tobacco, e-cigarettes, and nicotine replacement therapy – may also increase the risk of serious cardiovascular events from CHC use. |
| Oxcarbazepine | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. |
| Phenytoin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. |
| Ritonavir | contraindications | … Hepatic adenomas or carcinomas 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 ). |
Every other medicine the ethinyl estradiol and norethindrone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Topiramate | drug interactions | … carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate and products containing St. John’s wort. |
Check ethinyl estradiol and norethindrone against other medicines
Source: FDA drug label (Blisovi Fe 1/20), Lupin Pharmaceuticals, Inc., effective November 18, 2025 (SPL set ddbb5d60-cacf-4672-935d-86d668287992), via openFDA; the full label on DailyMed
What do FAERS reports show for ethinyl estradiol and norethindrone?
The FDA Adverse Event Reporting System holds 3,631 reports that list ethinyl estradiol and norethindrone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 36 are coded as a death and 526 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ethinyl estradiol and norethindrone?
6 other medicines are given the same way (oral) and in the same FDA class as ethinyl estradiol and norethindrone or labeled mainly for the same use (birth control), the same class first. Birth control lists all 24 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Estradiol | Osteoporosis, Menopause symptoms | 21 labelers | $0.0635 per tablet 1 mg tablet | No current entry |
| Levonorgestrel | Birth control | 33 labelers | $6.33 per tablet 1.5 mg tablet | No current entry |
| Estrogens conjugated | Osteoporosis, Menopause symptoms | 1 labeler | $5.47 per tablet 0.625 mg tablet | No current entry |
| Bazedoxifene and estrogens conjugated | Osteoporosis | none listed | $6.48 per tablet 0.45-20 mg tablet | No current entry |
| Drospirenone and estradiol | Menopause symptoms | none listed | $6.37 per tablet 0.25 mg-0.5 mg tablet | No current entry |
| Ulipristal | Birth control | none listed | $37.10 per tablet 30 mg tablet | No current entry |
Every medicine labeled for the same conditions as ethinyl estradiol and norethindrone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ethinyl estradiol and norethindrone compare with medicines for the same use?
1 side-by-side page set ethinyl estradiol and norethindrone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ethinyl estradiol and norethindrone
- 6 medicines for the same use
- Other estrogens
- the pharmacologic class, with prices and generics
- Ethinyl estradiol and norethindrone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other