Respuestas rápidas
- ¿Para qué se usa Norelgestromin and ethinyl estradiol?
- La etiqueta aprobada por la FDA (Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., 16 de abril de 2026) dice, en inglés: “Norelgestromin 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. …” Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Cuáles son los efectos secundarios de Norelgestromin and ethinyl estradiol?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., 16 de abril de 2026) comienza así, en inglés: «The following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol transdermal system, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions (5.1)] Liver disease [see Warnings and Precautions (5.3)] Adverse reactions commonly reported by users of combination hormonal contraceptives are: Irregular uterine bleeding Nausea Breast tenderness Headache The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Norelgestromin and ethinyl estradiol?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., 16 de abril de 2026) comienza así, en inglés: «Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Norelgestromin and ethinyl estradiol tiene una advertencia en recuadro?
- Sí. La etiqueta de la FDA de Norelgestromin and Ethinyl Estradiol tiene una advertencia en recuadro, la advertencia más seria de la FDA. Léala en la etiqueta completa y pregunte a su farmacéutico.
- ¿Hay escasez de Norelgestromin and ethinyl estradiol?
- La FDA no indica una escasez actual para los productos de este medicamento (datos de la FDA del 30 de octubre de 2026).
- ¿Se ha retirado del mercado Norelgestromin and ethinyl estradiol?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Norelgestromin and ethinyl estradiol?
- 9 empresas tienen productos con receta de Norelgestromin and ethinyl estradiol en el directorio NDC de la FDA, entre ellas Mylan Pharmaceuticals Inc., Zydus Pharmaceuticals USA Inc. y AvKARE.
Para qué se usa Norelgestromin and ethinyl estradiol
Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.
Norelgestromin 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. …
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (patch, transdermal), Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc.; abarca 1 producto del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.
La FDA tiene 8 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.
Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
Advertencia en recuadro
La advertencia en recuadro («caja negra») es la advertencia más seria de la FDA en la etiqueta de un medicamento, para riesgos graves o mortales.
Esta etiqueta tiene una advertencia en recuadro. Leerla en la etiqueta completa →
7 de 8 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.
Norelgestromin and ethinyl estradiol: lo que dice la advertencia en recuadro
Cita de la advertencia en recuadro (Boxed Warning) de la etiqueta aprobada por la FDA. Se muestra en inglés.
WARNING: 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.
Leer más de esta sección
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. (4, 5.1) ● Norelgestromin and ethinyl estradiol transdermal is contraindicated for use in women with a BMI ≥ 30 kg/m 2. Women with a BMI ≥ 30 kg/m 2 who use norelgestromin and ethinyl estradiol transdermal may have a higher risk of venous thromboembolic events compared with women with a lower BMI. (4, 5.1, 8.8)
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Leer la etiqueta completa en DailyMed →
Efectos secundarios de Norelgestromin and ethinyl estradiol
Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.
The following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol transdermal system, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)] Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions (5.1)] Liver disease [see Warnings and Precautions (5.3)] Adverse reactions commonly reported by users of combination hormonal contraceptives are: Irregular uterine bleeding Nausea Breast tenderness Headache The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders.
Leer más de esta sección
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to norelgestromin and ethinyl estradiol transdermal system in 3330 sexually active women (3322 of whom had safety data) who participated in three Phase 3 clinical trials designed to evaluate contraceptive efficacy and safety. These subjects received six or 13 cycles of contraception (norelgestromin and ethinyl estradiol transdermal system or an oral contraceptive comparator in 2 of the trials). The women ranged in age from 18 to 45 years and were predominantly white (91%). The most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability. Adverse drug reactions reported by ≥ 2.5% of norelgestromin and ethinyl estradiol transdermal system-treated subjects in these trials are shown in Table 3.
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Norelgestromin and ethinyl estradiol
Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example CYP3A4) may decrease the effectiveness of CHCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with CHCs.
Leer más de esta sección
(7.1) 7.1 Effects of Other Drugs on Combined Hormonal Contraceptives Substances Decreasing the Plasma Concentrations of CHCs and Potentially Diminishing the Efficacy of CHCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. 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. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. 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%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. 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/or progestin have been 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 transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]). 7.2 Effects of Combined Hormonal 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. CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Norelgestromin and ethinyl estradiol
Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.
To achieve maximum contraceptive effectiveness, norelgestromin and ethinyl estradiol transdermal system must be used exactly as directed. Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling. Norelgestromin and ethinyl estradiol transdermal system uses a 28-day (4-week) cycle. Apply a new patch to the upper outer arm, abdomen, buttock or back each week for 3 weeks (21 total days). Week 4 is patch-free.
Leer más de esta sección
(2.1, 2.3) Apply each new patch on the same day of the week. Wear only one patch at a time. (2.1) Do not cut or alter the patch in any way. (2.1) 2.1 How to Use Norelgestromin and Ethinyl Estradiol Transdermal System The norelgestromin and ethinyl estradiol transdermal system uses a 28-day (4-week) cycle. A new patch is applied each week for 3 weeks (21 total days). Week 4 is patch-free. Withdrawal bleeding is expected during this time. Every new patch should be applied on the same day of the week. This day is known as the "Patch Change Day." For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. Do not cut, damage or alter the norelgestromin and ethinyl estradiol transdermal system patch in any way. If the norelgestromin and ethinyl estradiol transdermal system patch is cut, damaged or altered in size, contraceptive efficacy may be impaired. On the day after Week 4 ends, a new 4-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles. 2.2 How to Start Using Norelgestromin and Ethinyl Estradiol Transdermal System There are multiple options for starting the Norelgestromin and Ethinyl Estradiol transdermal system, and the woman should choose the option that is most appropriate (see Table 1): Table 1: Instructions for Administration Starting Norelgestromin and Ethinyl Estradiol Transdermal System in women with no current use of hormonal contraception The woman has two options for starting the patch and she should choose the option that is right for her: First Day Start The woman should apply her first patch during the first 24 hours of her menstrual period. If a patch is applied after the first 24 hours of menstruation, non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) is needed for the first 7 days of the first cycle only. The woman should apply a new patch each week for three weeks (21 total days). Every new patch should be applied on the same day of the week. This day is known as the "Patch Change Day." For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time. No patch is worn during Week Four (the "Patch-Free Week"). Withdrawal bleeding is expected during this time. On the day after Week 4 ends, a new 4-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles. Sunday Start The woman should apply her first patch on the first Sunday after her menstrual period begins.
Tabla de la etiqueta
| • The woman should tear open the pouch at the edge. She should gently remove the contents of the foil pouch and discard the additional piece of film above the patch. | |
|---|---|
| • The woman should peel away half of the clear plastic. She should avoid touching the sticky surface with her fingers. | |
| • The woman should apply the sticky side of the patch on the skin she has cleaned and dried. She should then remove the other half of the clear plastic and attach the entire patch to her skin. | |
| • The woman should press firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. • She should run her fingers over the entire surface area to smooth out any "wrinkles" around the outer edges of the patch. |
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Norelgestromin and ethinyl estradiol en el embarazo
Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.
There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose hormonal contraceptives prior to conception or during early pregnancy.
Leer más de esta sección
The administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion.
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Leer la etiqueta completa en DailyMed →
Norelgestromin and ethinyl estradiol y la lactancia
Cita de la parte sobre lactancia (Nursing Mothers) de la etiqueta aprobada por la FDA. Se muestra en inglés.
The effects of norelgestromin and ethinyl estradiol transdermal system in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.
Leer más de esta sección
Small amounts of contraceptive steroids and/or metabolites are present in breast milk.
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Norelgestromin and ethinyl estradiol
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
Norelgestromin and ethinyl estradiol transdermal system is contraindicated in females who are known to have or develop the following conditions: ● At high risk of arterial or venous thromboembolic events.
Leer más de esta sección
Examples include women who: ○ Smoke, if over age 35 [see Boxed Warning, and Warnings and Precautions (5.1)] ○ Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] ○ Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] ○ Have cerebrovascular disease [see Warnings and Precautions (5.1)] ○ Have coronary artery disease [see Warnings and Precautions (5.1)] ○ Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] ○ Have uncontrolled hypertension [see Warnings and Precautions (5.5)] ○ Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7)] ○ Have headaches with focal neurological symptoms or have migraine headaches with aura ■ Women over age 35 with any migraine headaches [see Warnings and Precautions (5.8)] ● Body Mass Index ≥ 30 kg/m 2 [see Warnings and Precautions (5.1)] ● Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] ● Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)] ● Pregnancy, because there is no reason to use hormonal contraceptives during pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)] ● Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.12)] ● Use 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 Precautions (5.4)] At high risk of arterial or venous thromboembolic events (4) BMI ≥ 30 kg/m 2 (4) Breast cancer or other estrogen- or progestin-sensitive cancer (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Pregnancy (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4)
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Leer la etiqueta completa en DailyMed →
Sobredosis de Norelgestromin and ethinyl estradiol
Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).
Overdosage may cause nausea and vomiting, and withdrawal bleeding may occur in women. In case of suspected overdose, all norelgestromin and ethinyl estradiol transdermal system patches should be removed and symptomatic treatment given.
— Etiqueta de la FDA: Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
Lo que pagan las farmacias (NADAC)
El Costo Promedio Nacional de Adquisición de Medicamentos (NADAC, por sus siglas en inglés) es el precio promedio que pagaron las farmacias minoristas de los EE. UU. por comprar una unidad de un medicamento (una tableta, un mL o un gramo), según una encuesta mensual de facturas de farmacias de los Centros de Servicios de Medicare y Medicaid (CMS). Los programas estatales de Medicaid lo usan para pagar a las farmacias.
Este no es el precio que usted paga. Lo que usted paga depende de su seguro médico (copago o coseguro), de su farmacia y de los descuentos, y las farmacias también cobran por despachar una receta. Pregunte a su farmacéutico o a su plan de salud cuál será su precio.
| Concentración y forma | Genérico o de marca | Pagan las farmacias |
|---|---|---|
| ethinyl estradiol 35 ug/d · norelgestromin 150 ug/d parche | Genérico | $31.99–$37.12 por parche 2 envases, del más bajo al más alto |
| ethinyl estradiol 35 ug/mg · norelgestromin 150 ug/mg parche | Genérico | $31.32 por parche |
Lista NADAC del 4 de noviembre de 2026; estos precios rigen desde el 21 de octubre de 2026. Solo se muestra cuando el código NDC de un envase coincide exactamente con la lista NADAC, y solo para esa concentración y forma: no se promedia entre concentraciones. Las concentraciones y formas que no aparecen aquí no tienen precio NADAC.
Empresas que tienen este medicamento
Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.
- Mylan Pharmaceuticals Inc.1 producto
- Zydus Pharmaceuticals USA Inc.1 producto
- AvKARE1 producto
- Viatris Specialty LLC1 producto
- A-S Medication Solutions1 producto
- Amneal Pharmaceuticals NY LLC1 producto
- Amneal Pharmaceuticals LLC1 producto
- Bryant Ranch Prepack1 producto
- Zydus Lifesciences Limited1 producto
Historial de aprobación de la FDA
- NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
- ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.
| Solicitud | Patrocinador | Aprobada | Cambios aprobados después |
|---|---|---|---|
| NDA219990 GWYN LO | Viatris Specialty | 28 de julio de 2026 | — |
Aprobaciones de genéricos (3)
- ANDA200910Mylan Technologies · 16 de abril de 2014
- ANDA213950Amneal · 25 de febrero de 2021
- ANDA214594Zydus Pharms · 14 de septiembre de 2023
Escasez
La lista de escasez de la FDA no incluye estos productos.
Retiros del mercado
No aparece ningún retiro vinculado a estos productos (por su código NDC) en los informes de la FDA.
Identificadores oficiales
| RxCUI (RxNorm) | 1534809, 1536586, 2531285 |
|---|---|
| ID (SPL set ID) de la etiqueta citada | 10fa1458-c8ed-4197-922a-1ba7271d2b02 |
| Etiquetas de la FDA (SPL) | 8 |
| Solicitudes de la FDA | NDA219990, 3 ANDA |
| Principios activos (FDA) | ETHINYL ESTRADIOL / NORELGESTROMIN |
Siguientes pasos
- Encuentre una farmacia cerca de ustedPregunte qué precio le corresponde y si su producto está afectado por un retiro
- Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
- ZafemyPágina de marca: productos, fabricante y precio
- XulanePágina de marca: productos, fabricante y precio
- Gwyn LoPágina de marca: productos, fabricante y precio
- Mylan Pharmaceuticals Inc.Fabricante o distribuidor
- Zydus Pharmaceuticals USA Inc.Fabricante o distribuidor
- AvKAREFabricante o distribuidor
- Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español
Fuentes
- Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Norelgestromin and Ethinyl Estradiol, Zydus Pharmaceuticals USA Inc., vigente desde el 16 de abril de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →
Informar un error → · Información para fabricantes de medicamentos