RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "67046-667-60",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-667-60)",
      "NDC11Code": "67046-0667-60",
      "ProductNDC": "67046-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NC l2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
    },
    {
      "NDCCode": "67046-667-07",
      "PackageDescription": "7 TABLET in 1 BLISTER PACK (67046-667-07)",
      "NDC11Code": "67046-0667-07",
      "ProductNDC": "67046-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NC l2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
    },
    {
      "NDCCode": "67046-667-14",
      "PackageDescription": "14 TABLET in 1 BLISTER PACK (67046-667-14)",
      "NDC11Code": "67046-0667-14",
      "ProductNDC": "67046-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NC l2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
    },
    {
      "NDCCode": "67046-667-15",
      "PackageDescription": "15 TABLET in 1 BLISTER PACK (67046-667-15)",
      "NDC11Code": "67046-0667-15",
      "ProductNDC": "67046-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NC l2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
    },
    {
      "NDCCode": "67046-667-20",
      "PackageDescription": "20 TABLET in 1 BLISTER PACK (67046-667-20)",
      "NDC11Code": "67046-0667-20",
      "ProductNDC": "67046-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NC l2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
    },
    {
      "NDCCode": "67046-667-21",
      "PackageDescription": "21 TABLET in 1 BLISTER PACK (67046-667-21)",
      "NDC11Code": "67046-0667-21",
      "ProductNDC": "67046-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NC l2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
    },
    {
      "NDCCode": "67046-667-28",
      "PackageDescription": "28 TABLET in 1 BLISTER PACK (67046-667-28)",
      "NDC11Code": "67046-0667-28",
      "ProductNDC": "67046-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NC l2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
    },
    {
      "NDCCode": "67046-667-30",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-667-30)",
      "NDC11Code": "67046-0667-30",
      "ProductNDC": "67046-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sertraline Hydrochloride",
      "NonProprietaryName": "Sertraline Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170920",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077397",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "SERTRALINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
      "Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NC l2HCl is represented by the following structural formula:. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
    },
    {
      "NDCCode": "33261-667-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (33261-667-60)",
      "NDC11Code": "33261-0667-60",
      "ProductNDC": "33261-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Estradiol",
      "NonProprietaryName": "Estradiol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19971028",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040197",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "ESTRADIOL",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Estradiol Tablets USP are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease., 5 Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)., 6 Prevention of osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.)The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.",
      "Description": "Estradiol Tablets USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol per tablet. Estradiol (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is. Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake."
    },
    {
      "NDCCode": "49973-667-60",
      "PackageDescription": "60 BLISTER PACK in 1 BOX (49973-667-60)  / 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "49973-0667-60",
      "ProductNDC": "49973-667",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Azo",
      "ProprietaryNameSuffix": "Yeast Plus",
      "NonProprietaryName": "Candida Albicans, Wood Creosote, Sodium Chloride, And Sulfur",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140101",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "i-Health, Inc.",
      "SubstanceName": "CANDIDA ALBICANS; WOOD CREOSOTE; SODIUM CHLORIDE; SULFUR",
      "StrengthNumber": "30; 30; 12; 12",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use. See your doctor if this is the first time you have vaginal itching and discomfort to find out if you have a vaginal yeast infection. : 1 Relieves the symptoms of itching and burning associated with vaginal yeast infections., 2 Relieves occasional vaginal odor and discharge."
    },
    {
      "NDCCode": "55700-667-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (55700-667-60) ",
      "NDC11Code": "55700-0667-60",
      "ProductNDC": "55700-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Tartrate",
      "NonProprietaryName": "Metoprolol Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180810",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200981",
      "LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
      "SubstanceName": "METOPROLOL TARTRATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180810",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63187-667-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (63187-667-60) ",
      "NDC11Code": "63187-0667-60",
      "ProductNDC": "63187-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glyburide",
      "NonProprietaryName": "Glyburide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101005",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090937",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "GLYBURIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Active",
      "LastUpdate": "2019-11-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20181201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Glyburide tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Glyburide tablets, USP contain a smaller particle size glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as glyburide tablets, USP of 1.25, 2.5, and 5 mg strengths for oral administration. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. In addition, the 2.5 mg contains FD&C Red No.40 and the 5 mg contains FD&C Blue No.1. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)-ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below."
    },
    {
      "NDCCode": "65841-667-14",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (65841-667-14) ",
      "NDC11Code": "65841-0667-14",
      "ProductNDC": "65841-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Risperidone",
      "NonProprietaryName": "Risperidone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081113",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078040",
      "LabelerName": "Zydus Lifesciences Limited",
      "SubstanceName": "RISPERIDONE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20081113",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71205-667-60",
      "PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-667-60) ",
      "NDC11Code": "71205-0667-60",
      "ProductNDC": "71205-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxybutynin Chloride",
      "NonProprietaryName": "Oxybutynin Chloride",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207138",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "OXYBUTYNIN CHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-06-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220608",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oxybutynin chloride extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).",
      "Description": "Oxybutynin chloride extended-release tablet, USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet, USP contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22H 31NO 3HCl. Its structural formula is. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets, USP contains the following inert ingredients: colloidal anhydrous silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type-c, microcrystalline cellulose, polyethylene glycol, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Coloring agents are ferric oxide yellow (in all strengths), ferric oxide red (in 5 mg and 10 mg only) and ferric oxide black (in 15 mg only). System Components and Performance. Oxybutynin chloride extended-release tablets, USP are formulated to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet surrounded by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases drug at a controlled rate via diffusion and/or erosion. Oxybutynin chloride extended-release tablets, USP meets USP dissolution test 5."
    },
    {
      "NDCCode": "71610-667-53",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (71610-667-53) ",
      "NDC11Code": "71610-0667-53",
      "ProductNDC": "71610-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204989",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2022-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
      "Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
    },
    {
      "NDCCode": "71610-667-60",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (71610-667-60) ",
      "NDC11Code": "71610-0667-60",
      "ProductNDC": "71610-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204989",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2022-10-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20221010",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
      "Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
    },
    {
      "NDCCode": "72288-667-40",
      "PackageDescription": "6 BOTTLE in 1 CARTON (72288-667-40)  / 60 mL in 1 BOTTLE (72288-667-00) ",
      "NDC11Code": "72288-0667-40",
      "ProductNDC": "72288-667",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hair Regrowth Treatment",
      "NonProprietaryName": "Minoxidil",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260903",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075598",
      "LabelerName": "Amazon.com Services LLC",
      "SubstanceName": "MINOXIDIL",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260903",
      "SamplePackage": "N",
      "IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)."
    },
    {
      "NDCCode": "76420-667-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE (76420-667-60) ",
      "NDC11Code": "76420-0667-60",
      "ProductNDC": "76420-667",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methocarbamol",
      "NonProprietaryName": "Methocarbamol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040489",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "METHOCARBAMOL",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240208",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
      "Description": "Methocarbamol Tablets, USP, 500 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains either 500 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid."
    },
    {
      "NDCCode": "67046-023-60",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-023-60) ",
      "NDC11Code": "67046-0023-60",
      "ProductNDC": "67046-023",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharbetol",
      "ProprietaryNameSuffix": "Regular Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070109",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Coupler Enterprises",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20070109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves minor aches and pains due to. the common coldheadachebackacheminor pain of arthritistoothachemuscular achesmenstrual cramps. Temporarily reduces fever."
    },
    {
      "NDCCode": "67046-023-62",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-023-62) ",
      "NDC11Code": "67046-0023-62",
      "ProductNDC": "67046-023",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pharbetol",
      "ProprietaryNameSuffix": "Regular Strength",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070109",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Coupler Enterprises",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20070109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves minor aches and pains due to. the common coldheadachebackacheminor pain of arthritistoothachemuscular achesmenstrual cramps. Temporarily reduces fever."
    },
    {
      "NDCCode": "67046-024-60",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-024-60)",
      "NDC11Code": "67046-0024-60",
      "ProductNDC": "67046-024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100802",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
    },
    {
      "NDCCode": "67046-024-62",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-024-62)",
      "NDC11Code": "67046-0024-62",
      "ProductNDC": "67046-024",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100802",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
    },
    {
      "NDCCode": "67046-025-60",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-025-60)",
      "NDC11Code": "67046-0025-60",
      "ProductNDC": "67046-025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100802",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
    },
    {
      "NDCCode": "67046-025-62",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-025-62)",
      "NDC11Code": "67046-0025-62",
      "ProductNDC": "67046-025",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100802",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "325",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
    },
    {
      "NDCCode": "67046-026-60",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-026-60)",
      "NDC11Code": "67046-0026-60",
      "ProductNDC": "67046-026",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Extra Strength Acetaminophen",
      "NonProprietaryName": "Extra Strength Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100802",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
    },
    {
      "NDCCode": "67046-026-62",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-026-62)",
      "NDC11Code": "67046-0026-62",
      "ProductNDC": "67046-026",
      "ProductTypeName": "HUMAN OTC DRUG",
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      "NonProprietaryName": "Extra Strength Acetaminophen",
      "DosageFormName": "TABLET",
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      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
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      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
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      "StrengthUnit": "mg/1",
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      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
    },
    {
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      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-027-60)",
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      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
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      "LabelerName": "Contract Pharmacy Services-PA",
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      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
    },
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      "NDCCode": "67046-027-62",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-027-62)",
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      "ProductTypeName": "HUMAN OTC DRUG",
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      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100802",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily reduces fever . temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps ."
    },
    {
      "NDCCode": "67046-028-60",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-028-60) ",
      "NDC11Code": "67046-0028-60",
      "ProductNDC": "67046-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen Es",
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      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060110",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20060110",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves minor aches and pains due to: 1 headache, 2 backache, 3 minor pain of arthritis, 4 toothache, 5 muscular aches, 6 menstrual cramps."
    },
    {
      "NDCCode": "67046-028-62",
      "PackageDescription": "60 TABLET in 1 BLISTER PACK (67046-028-62) ",
      "NDC11Code": "67046-0028-62",
      "ProductNDC": "67046-028",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Acetaminophen Es",
      "NonProprietaryName": "Pharbetol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060110",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20060110",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves minor aches and pains due to: 1 headache, 2 backache, 3 minor pain of arthritis, 4 toothache, 5 muscular aches, 6 menstrual cramps."
    }
  ]
}
                    

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<NDCList><NDC><NDCCode>67046-667-60</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67046-667-07</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67046-667-14</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67046-667-15</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67046-667-20</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67046-667-21</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67046-667-28</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67046-667-30</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>33261-667-60</NDCCode><ProprietaryName>Estradiol</ProprietaryName><NonProprietaryName>Estradiol</NonProprietaryName></NDC><NDC><NDCCode>49973-667-60</NDCCode><ProprietaryName>Azo</ProprietaryName><NonProprietaryName>Candida Albicans, Wood Creosote, Sodium Chloride, And Sulfur</NonProprietaryName></NDC><NDC><NDCCode>55700-667-60</NDCCode><ProprietaryName>Metoprolol Tartrate</ProprietaryName><NonProprietaryName>Metoprolol Tartrate</NonProprietaryName></NDC><NDC><NDCCode>63187-667-60</NDCCode><ProprietaryName>Glyburide</ProprietaryName><NonProprietaryName>Glyburide</NonProprietaryName></NDC><NDC><NDCCode>65841-667-14</NDCCode><ProprietaryName>Risperidone</ProprietaryName><NonProprietaryName>Risperidone</NonProprietaryName></NDC><NDC><NDCCode>71205-667-60</NDCCode><ProprietaryName>Oxybutynin Chloride</ProprietaryName><NonProprietaryName>Oxybutynin Chloride</NonProprietaryName></NDC><NDC><NDCCode>71610-667-53</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>71610-667-60</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>72288-667-40</NDCCode><ProprietaryName>Hair Regrowth Treatment</ProprietaryName><NonProprietaryName>Minoxidil</NonProprietaryName></NDC><NDC><NDCCode>76420-667-60</NDCCode><ProprietaryName>Methocarbamol</ProprietaryName><NonProprietaryName>Methocarbamol</NonProprietaryName></NDC><NDC><NDCCode>67046-023-60</NDCCode><ProprietaryName>Pharbetol</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-023-62</NDCCode><ProprietaryName>Pharbetol</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-024-60</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-024-62</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-025-60</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-025-62</NDCCode><ProprietaryName>Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-026-60</NDCCode><ProprietaryName>Extra Strength Acetaminophen</ProprietaryName><NonProprietaryName>Extra Strength Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-026-62</NDCCode><ProprietaryName>Extra Strength Acetaminophen</ProprietaryName><NonProprietaryName>Extra Strength Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-027-60</NDCCode><ProprietaryName>Extra Strength Acetaminophen</ProprietaryName><NonProprietaryName>Extra Strength Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-027-62</NDCCode><ProprietaryName>Extra Strength Acetaminophen</ProprietaryName><NonProprietaryName>Extra Strength Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>67046-028-60</NDCCode><ProprietaryName>Acetaminophen Es</ProprietaryName><NonProprietaryName>Pharbetol</NonProprietaryName></NDC><NDC><NDCCode>67046-028-62</NDCCode><ProprietaryName>Acetaminophen Es</ProprietaryName><NonProprietaryName>Pharbetol</NonProprietaryName></NDC></NDCList>