Prescription medicine
Ethinyl estradiol and norelgestromin Brand names: Gwyn, Zafemy, Xulane; first approved as Ortho Evra
Ethinyl estradiol and norelgestromin (Xulane) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $37.16 per xulane 150-35 mcg/day patch in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and norelgestromin FDA label on DailyMed (effective April 16, 2026, Zydus Pharmaceuticals USA Inc.); the NDA 21180 record on Drugs@FDA; every ethinyl estradiol and norelgestromin label on DailyMed.
Highlights of the record
FDA label of April 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR.
EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI |GTE 30 kg/m2
Cigarette Smoking and Serious Cardiovascular Events Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including norelgestromin and ethinyl estradiol transdermal system, are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].
Contraindicated in Women with a BMI ≥ 30 kg/m 2 Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women with a BMI ≥ 30 kg/m 2 . The risk of VTE may be greater with norelgestromin and ethinyl estradiol transdermal in women with a BMI ≥ 30 kg/m 2 compared to women with a lower BMI [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m 2 See full prescribing information for complete boxed warning.
Norelgestromin and ethinyl estradiol transdermal is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. […]
Used for
From the label: indications and usageNorelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate.
Forms and strengths
Patch.
On the market
- Earliest approval on file
- November 20, 2001 Ortho Evra, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first April 16, 2014; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $37.16 per patch Xulane 150-35 mcg/day patch
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,837 through July 30, 2026
What is ethinyl estradiol and norelgestromin used for?
From the label: indications and usageNorelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with BMI ≥ 30 kg/m2 [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) and Clinical Studies ( 14 ) ]. […]
Conditions named in the indications of ethinyl estradiol and norelgestromin's FDA labels, with every medicine labeled for each:
Source: FDA drug label (norelgestromin and ethinyl estradiol), Zydus Pharmaceuticals USA Inc., effective April 16, 2026 (SPL set 10fa1458-c8ed-4197-922a-1ba7271d2b02), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and norelgestromin (Xulane)?
The FDA approved the first generic ethinyl estradiol and norelgestromin on April 16, 2014. 4 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ethinyl estradiol and norelgestromin from 8 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.
- 2001 earliest approval on file
- 2014 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ethinyl estradiol and norelgestromin (Xulane)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $37.16 per Xulane 150-35 mcg/day patch, about the same as a year earlier. 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.
- Zafemy 150-35 mcg/day patch (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Norelgestrom-ee 150-35 mcg/day | Generic | $33.29 per unit | n/a | -9% |
| Xulane 150-35 mcg/day patch | Generic | $37.16 per patch | n/a | -0.8% |
| Zafemy 150-35 mcg/day patch | Generic | $31.91 per patch | n/a | +14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ethinyl estradiol and norelgestromin label say about other medicines?
The ethinyl estradiol and norelgestromin label names 39 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 EE concentrations, possibly by inhibition of conjugation. |
| Aprepitant | 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, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Ascorbic acid | drug interactions | Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. |
| Atazanavir | drug interactions | … (fos)amprenavir/ritonavir, lopinavir/ritnoavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). |
| Atorvastatin | drug interactions | Substances Increasing the Plasma Concentrations of CHCs Co-administration of atorvastatin or rosuvastatin and certain CHCs containing EE increase AUC values for EE by approximately 20% to 25%. |
| 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, rifabutin, rufinamide, aprepitant, 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, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Colesevelam | drug interactions | Concomitant use of CHCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol. |
| Cyclosporine | drug interactions | Contraceptives on Other Drugs CHCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. |
| Darunavir | drug interactions | … noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritnoavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors or with non-nucleoside reverse … |
| Efavirenz | drug interactions | Continue backup contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. … |
| Etravirine | drug interactions | … inhibitors or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). |
| 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, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Fluconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
Every other medicine the ethinyl estradiol and norelgestromin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Glecaprevir and pibrentasvir | drug interactions | Use with Direct Acting Antiviral Agents (DAAs) – Liver Enzyme Elevation During clinical trials with the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir and dasabuvir, with and or … |
| Griseofulvin | drug interactions | … include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Itraconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
| Ketoconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
| Lamotrigine | drug interactions | Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. |
| Lopinavir and ritonavir | drug interactions | Significant decreases in systemic exposure of the estrogen and/or progestin have been noted when CHCs are co-administered with some HIV protease inhibitors (e.g., nelfinavir, ritonavir … |
| Morphine | drug interactions | CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. |
| Nelfinavir | drug interactions | … of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritnoavir, and tipranavir/ritonavir] or increase … |
| Nevirapine | drug interactions | … with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). |
| Oxcarbazepine | drug interactions | … phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, 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 … |
| Prednisolone | drug interactions | Contraceptives on Other Drugs CHCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma … |
| Ribavirin | contraindications | Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, due to the potential for alanine aminotransferase (ALT) elevations [see … |
| Rifabutin | drug interactions | … bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Rifampin | drug interactions | … carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John’s wort, Induction potency of St. … |
| Ritonavir | contraindications | … of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (ALT) elevations [see Warnings and … |
| Rosuvastatin | drug interactions | Substances Increasing the Plasma Concentrations of CHCs Co-administration of atorvastatin or rosuvastatin and certain CHCs containing EE increase AUC values for EE by approximately 20% to 25%. |
| Rufinamide | drug interactions | … felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Salicylic acid | drug interactions | CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Use with Direct Acting Antiviral Agents (DAAs) – Liver Enzyme Elevation During clinical trials with the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir and dasabuvir, with and or … |
| Temazepam | drug interactions | CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. |
| Theophylline | drug interactions | Contraceptives on Other Drugs CHCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma … |
| Tizanidine | drug interactions | Contraceptives on Other Drugs CHCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma … |
| Topiramate | drug interactions | … carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. |
| Voriconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
Check ethinyl estradiol and norelgestromin against other medicines
Source: FDA drug label (norelgestromin and ethinyl estradiol), Zydus Pharmaceuticals USA Inc., effective April 16, 2026 (SPL set 10fa1458-c8ed-4197-922a-1ba7271d2b02), via openFDA; the full label on DailyMed
What do FAERS reports show for ethinyl estradiol and norelgestromin?
The FDA Adverse Event Reporting System holds 1,837 reports that list ethinyl estradiol and norelgestromin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 66 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 next?
- Other estrogens
- the pharmacologic class, with prices and generics
- Ethinyl estradiol and norelgestromin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other