Doxepina (doxepin hydrochloride)

Para qué se usa Doxepina

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.

Doxepin Hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin Hydrochloride capsules are a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults.

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (capsule, oral), Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC; abarca 5 productos 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 99 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.

Enfermedades que menciona la etiqueta

Estos nombres aparecen tal cual en la sección «Indications and Usage» de la etiqueta (según una tabla revisada). Cada página muestra los hospitales cuyos sitios web mencionan la enfermedad.

Especialidades médicas relacionadas

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. Su título: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS. Leerla en la etiqueta completa →

74 de 99 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Doxepina: 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: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Doxepin Hydrochloride is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.

• Increased risk of suicidal thoughts and behaviors in pediatric and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1)
• Doxepin Hydrochloride capsules is not approved for use in pediatric patients (8.4)

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Doxepina

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 clinically significant adverse reactions are described elsewhere in the labeling:

• Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)]
• Serotonin Syndrome [see Warnings and Precautions (5.2)]
• Angle-Closure Glaucoma [see Warnings and Precautions (5.3)]
• Sedation and Driving Risks [see Warnings and Precautions (5.4)]
• Activation of Mania or Hypomania [see Warnings and Precautions (5.5)]
• Risk of Seizures [see Warnings and Precautions (5.6)]
• Psychosis [see Warnings and Precautions (5.7)] Most common adverse reactions (incidence ≥ 5%) are somnolence, dry mouth, dizziness, constipation and fatigue.

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(6.1). To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at1-800-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 practice. Adverse reactions (≥ 2% of doxepin hydrochloride-treated patients) in 1,635 doxepin hydrochloride-treated patients with MDD in clinical trials included somnolence (17%), dry mouth (15%), dizziness (6%), constipation (5%), fatigue (5%), blurred vision (3%), tachycardia (3%), hypotension (3%), insomnia (2%), tremor (2%), nausea (2%), hyperhidrosis (2%), and increased weight (2%). Other Adverse Reactions Observed in Clinical Trials Other adverse reactions that occurred at an incidence of < 2% in patients treated with doxepin hydrochloride in clinical trials were:

• Ear and Labyrinth Disorders: Tinnitus.
• Gastrointestinal Disorders: Diarrhea, dyspepsia, vomiting.
• General Disorders and Administration Site Conditions: Asthenia, edema, chills.
• Metabolism and Nutrition Disorders: Decreased appetite.
• Nervous System Disorders: Ataxia, paresthesia, headache, extrapyramidal disorder.
• Psychiatric Disorders: Agitation, confusional state, libido decreased.
• Pulmonary Disorders: Asthma exacerbation.
• Renal and Urinary Disorders: Urinary retention.
• Reproductive System and Breast Disorders: Breast enlargement.
• Skin & Subcutaneous Tissue Disorders: Rash, pruritus.
• Vascular Disorders: Flushing. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of doxepin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Blood and Lymphatic System Disorders: Agranulocytosis, leukopenia, thrombocytopenia, eosinophilia, purpura.
• Cardiac Disorders: Conduction disorder, arrhythmia.
• Endocrine Disorders: Inappropriate antidiuretic hormone secretion.
• Eye Disorders: Angle-closure glaucoma, mydriasis.
• Gastrointestinal Disorders: Aphthous stomatitis, abdominal pain upper.
• General Disorders and Administration Site Conditions: Facial edema, hyperpyrexia.
• Hepatobiliary Disorders: Jaundice.
• Investigations: Blood glucose increased.
• Nervous System Disorders: Hypoesthesia, dysgeusia, convulsion, tardive dyskinesia, serotonin syndrome.
• Psychiatric Disorders: Hallucination, disorientation.
• Reproductive System and Breast Disorders: Testicular swelling, gynecomastia, galactorrhea.

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Doxepina

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.

Table 2 describe the clinically significant drug interactions of doxepin hydrochloride with other drugs or classes. Table 2: Clinically Significant Drug Interactions with doxepin hydrochloride Monoamine Oxidase Inhibitors Prevention or Management Doxepin Hydrochloride is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue.

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The use of doxepin hydrochloride within14 days of discontinuation of an MAOI or the use of MAOI within 14 days of discontinuation of doxepin hydrochloride is contraindicated. Starting doxepin hydrochloride in a patient who is being treated with an MAOI is contraindicated. Clinical Effect(s) Concomitant use of doxepin hydrochloride and MAOIs increases the risk of serotonin syndrome [Warnings and Precautions (5.2)]. Other Serotonergic Drugs (Besides MAOIs) Prevention or Management Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of doxepin hydrochloride and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2)]. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride with other serotonergic drugs increases the risk of serotonin syndrome [see Warnings and Precautions (5.2)]. Strong CYP2D6 Inhibitors Prevention or Management Monitor doxepin plasma concentrations and reduce the doxepin hydrochloride dosage or the strong CYP2D6 inhibitor as appropriate [see Dosage and Administration (2.5)]. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride with strong CYP2D6 inhibitors may increase the exposures of doxepin [see Clinical Pharmacology (12.3)] which may increase the risk of doxepin hydrochloride related adverse reactions [see Warnings and Precautions (5) and Adverse Reactions (6)]. Examples Seewww.fda.gov/CYPandTransporterInteractingDrugs for examples of strong CYP2D6 Inhibitors. Carbamazepine Prevention or Management Monitor doxepin plasma concentrations and consider increasing the doxepin hydrochloride dosage in patients taking carbamazepine. Mechanism and Clinical Effect(s) Concomitant use of carbamazepine with doxepin hydrochloride decreases the exposure of doxepin [see Clinical Pharmacology (12.3)] which could lead to reduced treatment effect. Cimetidine Prevention or Management Monitor doxepin plasma concentrations and consider reducing the doxepin hydrochloride dosage in patients taking cimetidine. Mechanism and Clinical Effect(s) Concomitant use of doxepin hydrochloride with cimetidine may increase the exposures of doxepin [see Clinical Pharmacology (12.3)] which may increase the risk of doxepin hydrochloride-related anticholinergic effects (e.g., dry mouth, blurred vision, constipation) [see Adverse Reactions (6.1)]. Alcohol Prevention or Management Avoid concomitant use with alcohol. Mechanism and Clinical Effect(s) Doxepin Hydrochloride may potentiate the sedative effects of alcohol [see Warnings and Precautions (5.4)].

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Doxepina

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.

• Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. (2.1)
• Recommended starting oral dosage is 25 mg three times daily or 75 mg once daily. (2.2)
• Recommended target total dosage range is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). (2.2)
• Maximum recommended dosage is 100 mg three times daily.

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(2.2)

• Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules. (2.3)
• See the Full Prescribing Information for dosage modifications intended to reduce the risk of anticholinergic effects, for strong CYP2D6 inhibitors, and in known CYP2D6 and CYP2C19 poor metabolizers. (2.4, 2.5, 2.6).
• When discontinuing doxepin hydrochloride capsules, gradually reduce the dosage until discontinued. (2.7) 2.1 Screen for Bipolar Disorder Prior to Starting doxepin hydrochloride capsules Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.5)]. 2.2 Recommended Dosage The recommended starting oral dosage for doxepin hydrochloride capsules are 25 mg three times daily or 75 mg once daily. The recommended target total oral dosage range for doxepin hydrochloride capsules are between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). The maximum recommended oral dosage for doxepin hydrochloride capsules are 100 mg three times daily. 2.3 Switching Patients to or from a Monoamine Oxidase Inhibitor Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules [see Contraindications (4), Warnings and Precautions (5.2), and Drug Interactions (7)]. Wait at least 14 days after discontinuation of doxepin hydrochloride capsules before initiating therapy with an MAOI [see Contraindications (4.4), Warnings and Precautions (5.2), and Drug Interactions (7)]. 2.4 Dosage Modifications Intended to Reduce the Risk of Anticholinergic Effects If anticholinergic effects (e.g., dry mouth, blurred vision, constipation) develop, reduce the doxepin hydrochloride capsules dosage [see Adverse Reactions (6.1)]. 2.5 Dosage Modifications for Strong CYP2D6 Inhibitors Reduce the doxepin hydrochloride capsules dosage based on doxepin plasma concentrations when used concomitantly with strong CYP2D6 inhibitors [see Drug Interactions (7)]. 2.6 Dosage Modifications in Known CYP2D6 and CYP2C19 Poor Metabolizers Reduce the doxepin hydrochloride capsules dosage based on doxepin plasma concentrations in patients who are known CYP2D6 and CYP2C19 poor metabolizers [see Use in Specific Populations (8.7)]. 2.7 Discontinuation of Doxepin Hydrochloride Capsules Treatment When discontinuing doxepin hydrochloride capsules, gradually reduce the dosage until discontinued [see Adverse Reactions (6)].

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Leer la etiqueta completa en DailyMed →

Doxepina 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.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including doxepin hydrochloride, during pregnancy. Health care providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants.

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Risk Summary Available data from published epidemiological studies and postmarketing reports have not established an increased risk for major birth defects or miscarriage with doxepin hydrochloride use (see Data). There are risks (see Clinical Considerations):

• To the mother associated with untreated depression in pregnancy.
• Poor neonate adaptation from exposure to tricyclic antidepressants (TCAs), including doxepin hydrochloride, during the third trimester of pregnancy. Animal reproduction toxicity of doxepin has not been fully characterized. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of MDD than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of MDD who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated MDD when considering discontinuation of doxepin hydrochloride drugs during pregnancy and the postpartum period. Fetal/Neonatal Adverse Reactions Neonates previously exposed to TCAs, including doxepin hydrochloride, late in the third trimester during pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome. Monitor neonates who were exposed to doxepin hydrochloride in the third trimester of pregnancy for poor neonatal adaptation syndrome. Data Human Data: Published epidemiological studies of pregnant women exposed to TCAs, including doxepin hydrochloride, have not established an association with major birth defects, miscarriage, or adverse maternal outcomes. Methodological limitations of these observational studies include small sample size and lack of adequate controls.

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Leer la etiqueta completa en DailyMed →

Doxepina y la lactancia

Cita de la parte sobre lactancia (Nursing Mothers) de la etiqueta aprobada por la FDA. Se muestra en inglés.

Pediatric Use The safety and effectiveness of doxepin hydrochloride in pediatric patients have not been established. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Warnings and Precautions (5.1)].

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Doxepina

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

Doxepin Hydrochloride is contraindicated in patients:

• With hypersensitivity to doxepin (hypersensitivity reactions have included tongue edema and urticaria). The possibility of cross sensitivity with other dibenzoxepines should be kept in mind.
• With glaucoma [see Warnings and Precautions (5.3)].
• With current or past urinary retention [see Adverse Reactions (6.1)].

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• Taking MAOIs, or within 14 days of stopping MAOIs (including the MAOIs linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7)].
• Hypersensitivity to doxepin (4)
• Glaucoma (4)
• Current or past urinary retention (4)
• Taking MAOIs, or within 14 days of stopping MAOIs (4)

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Doxepina

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).

Signs, Symptoms, and Complications of doxepin hydrochloride Overdose Serious manifestations of tricyclic antidepressant (TCA) overdose include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Deaths may occur from overdosage with TCAs, including doxepin hydrochloride. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of TCA toxicity.

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A maximal limb-lead QRS duration of ≥ 0.1 seconds may be the best indication of the TCA overdose severity. Signs and symptoms of TCA toxicity develop rapidly after TCA overdose. Other signs of TCA overdose may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, or hyperpyrexia. There are reports of patients succumbing to fatal dysrhythmia late after TCA overdose. Management of Overdose The following are recommendations for the management of a doxepin hydrochloride overdose. Contact the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations. With a doxepin hydrochloride overdose, obtain an ECG and immediately initiate cardiac monitoring in the hospital. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS depression, respiratory depression, hypotension, cardiac dysrhythmias, conduction blocks, and seizures is recommended. If signs of toxicity occur during this period, extended monitoring is recommended. Monitoring of plasma doxepin levels should not guide doxepin hydrochloride overdose management. Cardiovascular Toxicity Management: Intravenous sodium bicarbonate should be administered to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate to intravenous sodium bicarbonate therapy, hyperventilation may also be used. With concomitant use of hyperventilation and sodium bicarbonate therapy frequently monitor pH and pCO2. A pH > 7.6 or a pCO2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to intravenous sodium bicarbonate therapy/hyperventilation may respond to lidocaine therapy. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide) in the setting of TCA overdose. Hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in TCA overdose due to high tissue and protein binding of doxepin. CNS Toxicity Management: In patients with TCA overdose who have CNS depression, early intubation is recommended because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, propofol). Avoid use of physostigmine to treat TCA overdose.

— Etiqueta de la FDA: Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

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.

• Bryant Ranch Prepack19 productos
• Remedyrepack Inc.11 productos
• Mylan Pharmaceuticals Inc.8 productos
• Novadoz Pharmaceuticals LLC7 productos
• Aurobindo Pharma Limited7 productos
• Ajanta Pharma USA Inc.7 productos
• Leading Pharma, LLC6 productos
• Direct_Rx6 productos
• PD-Rx Pharmaceuticals, Inc.5 productos
• Puracap Laboratories LLC dba Blu Pharmaceuticals5 productos
• Alembic Pharmaceuticals Limited5 productos
• Rising Pharma Holdings, Inc.5 productos
• Florida Pharmaceutical Products, LLC5 productos
• First Nation Group, LLC5 productos
• Contract Pharmacal Corp.5 productos
• Appco Pharma LLC5 productos
• Amneal Pharmaceuticals LLC5 productos
• Proficient Rx LP5 productos
• NorthStar RxLLC5 productos
• Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5 productos
• Epic Pharma, LLC5 productos
• Chartwell RX, LLC5 productos
• Lifestar Pharma LLC5 productos
• Alembic Pharmaceuticals Inc.5 productos
• Major Pharmaceuticals4 productos
• Mylan Institutional Inc.4 productos
• Golden State Medical Supply, Inc.4 productos
• Safecor Health LLC4 productos
• A-S Medication Solutions4 productos
• Sun Pharmaceutical Industries, Inc.3 productos
• NorthStar Rx LLC2 productos
• Actavis Pharma, Inc.2 productos
• Viona Pharmaceuticals Inc2 productos
• Archis Pharma LLC2 productos
• Marlex Pharmaceuticals, Inc.2 productos
• Boswell Pharmacy Services LLC d/b/a BPS Wholesale2 productos
• Strides Pharma Science Limited2 productos
• Aphena Pharma Solutions - Tennessee, LLC2 productos
• Currax Pharmaceuticals LLC2 productos
• Coupler LLC2 productos
• Zydus Lifesciences Limited2 productos
• North Star Rx LLC2 productos
• Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven2 productos
• NuCare Pharmaceuticals, Inc.1 producto
• Teva Pharmaceuticals USA, Inc.1 producto
• Advanced Rx Pharmacy of Tennessee, LLC1 producto
• Advanced Rx of Tennessee, LLC1 producto
• Redpharm Drug1 producto
• Amneal Pharmaceuticals NY LLC1 producto
• Lannett Company, LLC1 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.

Aprobaciones de genéricos (27)

• ANDA070791Mylan Pharms Inc · 13 de mayo de 1986
• ANDA074721Lannett Co Inc · 29 de diciembre de 1998
• ANDA201951Actavis Elizabeth · 26 de julio de 2013
• ANDA202337Rk Pharma · 20 de enero de 2016
• ANDA207482Amneal Pharms Co · 28 de junio de 2017
• ANDA211603Aurobindo Pharma Ltd · 27 de marzo de 2019
• ANDA212624Ajanta Pharma Ltd · 13 de septiembre de 2019
• ANDA213063Taro · 1 de julio de 2020
• ANDA202510Strides Pharma Intl · 24 de julio de 2020
• ANDA213474Aiping Pharm Inc · 28 de julio de 2020
• ANDA210268Chartwell Rx · 4 de septiembre de 2020
• ANDA210675Epic Pharma LLC · 16 de octubre de 2020
• ANDA211618Velzen Pharma Pvt · 1 de marzo de 2021
• ANDA211619Leading · 9 de marzo de 2021
• ANDA214908Appco · 1 de abril de 2021
• ANDA215076Alembic · 21 de abril de 2021
• ANDA215710Mankind Pharma · 9 de febrero de 2022
• ANDA215113Msn · 24 de junio de 2022
• ANDA215408Teva Pharms · 17 de febrero de 2023
• ANDA214823Msn · 3 de abril de 2023
• ANDA202761Zydus Lifesciences · 16 de agosto de 2023
• ANDA212357Amneal · 16 de agosto de 2023
• ANDA217975Unique · 21 de agosto de 2023
• ANDA218564Ajanta Pharma Ltd · 1 de julio de 2024
• ANDA216041Aurobindo Pharma Ltd · 25 de julio de 2024
• ANDA219058Taro · 6 de agosto de 2025
• ANDA213919Sun Pharma Canada · 28 de abril de 2026

Escasez

La lista de escasez de la FDA no incluye estos productos.

Base de datos de escasez de medicamentos de la FDA →

Retiros del mercado

De los informes de la FDA, vinculados por el código NDC del producto. Un retiro suele afectar solo a lotes concretos: revise el número de lote del envase y pregunte a su farmacéutico. No deje un medicamento por su cuenta.

1. 25 de julio de 2025 · Clase II · En curso · D-0566-2025

   CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

   Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, — Alembic Pharmaceuticals Limited

Identificadores oficiales

Siguientes pasos

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• SilenorPágina de marca: productos, fabricante y precio
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• ZonalonPágina de marca: productos, fabricante y precio
• Trastorno depresivo mayorEnfermedad que menciona la etiqueta: hospitales que la tratan
• Bryant Ranch PrepackFabricante o distribuidor
• Remedyrepack Inc.Fabricante o distribuidor
• Mylan Pharmaceuticals Inc.Fabricante o distribuidor
• Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español

Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Doxepin Hydrochloride, Novadoz Pharmaceuticals LLC, vigente desde el 23 de julio de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. 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
3. 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
4. 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
5. 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
6. Nombre en español: RxNorm (Biblioteca Nacional de Medicina de EE. UU.) y Wikidata, vinculados por el identificador RxNorm (RxCUI) del principio activo, sin coincidencias aproximadas.

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 →

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