Prescription medicine
Ethinyl estradiol and ferrous fumarate and norethindrone Brand names: Taytulla, Junel, Microgestin, Aurovela, Hailey; first approved as Norminest Fe
Ethinyl estradiol and ferrous fumarate and norethindrone (Junel) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.142 per microgestin fe 1.5-30 tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and ferrous fumarate and norethindrone FDA label on DailyMed (effective May 21, 2026, PD-Rx Pharmaceuticals, Inc.); the NDA 17948 record on Drugs@FDA; every ethinyl estradiol and ferrous fumarate and norethindrone label on DailyMed.
Highlights of the record
FDA label of May 21, 2026; 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 Junel, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS ).
Used for
From the label: indications and usageJunel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- February 21, 1978 Norminest Fe, Gd Searle Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 23 of which 22 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.142 per tablet Microgestin fe 1.5-30 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 1 Class I among all firms' recalls; latest July 21, 2020
- FAERS reports
- 6,411 through July 30, 2026
What is ethinyl estradiol and ferrous fumarate and norethindrone used for?
From the label: indications and usageJunel 21 and Junel Fe 28 are 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 ferrous fumarate and norethindrone's FDA labels, with every medicine labeled for each:
From other ethinyl estradiol and ferrous fumarate and norethindrone labelsBirth control: INDICATIONS AND USAGE Junel 21 and Junel Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Acne: Xarah 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 …
FDA pharmacologic class: Estrogen.
Source: FDA drug label (Junel Fe 28 Day), ANDA076081 (Barr), as published by PD-Rx Pharmaceuticals, Inc., effective May 21, 2026 (SPL set 93a2f8c9-3550-42ec-8f76-3ac9badf4bb2), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and ferrous fumarate and norethindrone (Junel)?
No generic ethinyl estradiol and ferrous fumarate and norethindrone is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: 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 ferrous fumarate and norethindrone from 22 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1978 earliest approval on file
- 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 ferrous fumarate and norethindrone (Junel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.142 per Microgestin fe 1.5-30 tablet, down 8% from $0.153 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 fe 1.5-30 tablet (generic)
- Lo loestrin fe 1-10 tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aurovela 24 fe 1 mg-20 mcg tablet | Generic | $0.175 per tablet | $5.24 | -15% |
| Aurovela fe 1-20 tablet | Generic | $0.129 per tablet | $3.86 | -12% |
| Aurovela fe 1.5 mg-30 mcg tablet | Generic | $0.142 per tablet | $4.26 | -8% |
| Charlotte 24 fe chewable tablet | Generic | $0.304 per tablet | $9.12 | -4% |
| Feirza 1 mg-20 mcg tablet | Generic | $0.129 per tablet | $3.86 | -12% |
| Feirza 1.5 mg-30 mcg tablet | Generic | $0.142 per tablet | $4.26 | -8% |
| Finzala 1-0.02(24)-75 chewable tablet | Generic | $0.304 per tablet | $9.12 | -4% |
| Galbriela 0.8-0.025 mg chewable tablet | Generic | $1.40 per tablet | $42.11 | -25% |
| Gemmily 1 mg-20 mcg capsule | Generic | $0.962 per capsule | $28.85 | +18% |
| Hailey 24 fe 1 mg-20 mcg tablet | Generic | $0.175 per tablet | $5.24 | -15% |
| Hailey fe 1-20 tablet | Generic | $0.129 per tablet | $3.86 | -12% |
| Hailey fe 1.5-30 tablet | Generic | $0.142 per tablet | $4.26 | -8% |
| Junel fe 1 mg-20 mcg tablet | Generic | $0.129 per tablet | $3.86 | -12% |
| Junel fe 1.5 mg-30 mcg tablet | Generic | $0.142 per tablet | $4.26 | -8% |
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 ferrous fumarate and norethindrone been recalled?
The FDA's Enforcement Report lists 3 recalls naming ethinyl estradiol and ferrous fumarate and norethindrone since 2013: 1 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 21, 2020 | Class II | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test. |
| May 16, 2017 | Class I | Lupin Limited (Unit 1) | Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package. |
| 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 ferrous fumarate and norethindrone label say about other medicines?
The ethinyl estradiol and ferrous fumarate 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 levels, possibly by inhibition of conjugation. |
| Ascorbic acid | drug interactions | Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. |
| Atorvastatin | drug interactions | Increase i n Plasma Levels of Ethinyl Estradiol Associated with Co-Administered Drugs Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20 percent. |
| Bosentan | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: |
| Carbamazepine | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: |
| Felbamate | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: |
| Griseofulvin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: |
| Itraconazole | drug interactions | CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels. |
| Ketoconazole | drug interactions | CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels. |
| Lamotrigine | drug interactions | COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. |
| Oxcarbazepine | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: |
| Phenytoin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: |
| Rifampin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: |
| 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 ferrous fumarate and norethindrone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Topiramate | drug interactions | … felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: |
Check ethinyl estradiol and ferrous fumarate and norethindrone against other medicines
Source: FDA drug label (Junel Fe 28 Day), ANDA076081 (Barr), as published by PD-Rx Pharmaceuticals, Inc., effective May 21, 2026 (SPL set 93a2f8c9-3550-42ec-8f76-3ac9badf4bb2), via openFDA; the full label on DailyMed
What do FAERS reports show for ethinyl estradiol and ferrous fumarate and norethindrone?
The FDA Adverse Event Reporting System holds 6,411 reports that list ethinyl estradiol and ferrous fumarate and norethindrone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 679 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 ferrous fumarate and norethindrone?
2 other medicines are given the same way (oral) and in the same FDA class as ethinyl estradiol and ferrous fumarate 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 |
|---|---|---|---|---|
| Levonorgestrel | Birth control | 33 labelers | $6.33 per tablet 1.5 mg tablet | No current entry |
| Ulipristal | Birth control | none listed | $37.10 per tablet 30 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other estrogens
- the pharmacologic class, with prices and generics
- Ethinyl estradiol and ferrous fumarate and norethindrone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other