{
"NDC": [
{
"NDCCode": "51285-087-87",
"PackageDescription": "2 POUCH in 1 CARTON (51285-087-87) / 1 BLISTER PACK in 1 POUCH (51285-087-82) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0087-87",
"ProductNDC": "51285-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seasonique",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20060710",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021840",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060710",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "SEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "SEASONIQUE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "51285-092-87",
"PackageDescription": "2 POUCH in 1 CARTON (51285-092-87) / 1 BLISTER PACK in 1 POUCH (51285-092-82) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0092-87",
"ProductNDC": "51285-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loseasonique",
"NonProprietaryName": "Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20090323",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022262",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090323",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "LOSEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "LOSEASONIQUE (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "51285-431-87",
"PackageDescription": "2 POUCH in 1 CARTON (51285-431-87) / 1 KIT in 1 POUCH",
"NDC11Code": "51285-0431-87",
"ProductNDC": "51285-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quartette",
"NonProprietaryName": "Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20130725",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204061",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170410",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "QUARTETTE® is indicated for use by females of reproductive age to prevent pregnancy.",
"Description": "QUARTETTE (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets is an extended-cycle oral contraceptive. QUARTETTE consists of 42 light pink tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 pink tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol, and 21 purple tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen. The structural formulas, molecular formulas, molecular weights, and chemical names for the active components are shown below. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-(17α)- (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light pink tablet contains the following inactive ingredients:. anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide, and triacetin. Each pink tablet contains the following inactive ingredients:. anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin. Each purple tablet contains the following inactive ingredients:. anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 1/Brilliant Blue FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients. anhydrous lactose, D&C Yellow no. 10 aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol/macrogol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "53329-087-87",
"PackageDescription": ".9 g in 1 PACKET (53329-087-87) ",
"NDC11Code": "53329-0087-87",
"ProductNDC": "53329-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "53329-087-96",
"PackageDescription": "144 PACKET in 1 BOX (53329-087-96) / .9 g in 1 PACKET (53329-087-87) ",
"NDC11Code": "53329-0087-96",
"ProductNDC": "53329-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "62217-087-87",
"PackageDescription": "237 mL in 1 BOTTLE, PUMP (62217-087-87) ",
"NDC11Code": "62217-0087-87",
"ProductNDC": "62217-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fruit Of The Earth Honeysuckle Scented Antibacterial Hand With Canadian Willowherb",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210412",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FRUIT OF THE EARTH, INC.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210412",
"SamplePackage": "N",
"IndicationAndUsage": "helps reduce bacteria on hands."
},
{
"NDCCode": "16590-087-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-087-30)",
"NDC11Code": "16590-0087-30",
"ProductNDC": "16590-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Stat Rx USA",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23). Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of panic disorder, 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. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, 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 Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "16590-087-56",
"PackageDescription": "56 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-087-56)",
"NDC11Code": "16590-0087-56",
"ProductNDC": "16590-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Stat Rx USA",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23). Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of panic disorder, 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. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, 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 Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "16590-087-60",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-087-60)",
"NDC11Code": "16590-0087-60",
"ProductNDC": "16590-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Stat Rx USA",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23). Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of panic disorder, 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. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, 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 Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
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"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-087-90)",
"NDC11Code": "16590-0087-90",
"ProductNDC": "16590-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
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"LabelerName": "Stat Rx USA",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
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"IndicationAndUsage": "Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23). Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of panic disorder, 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. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, 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 Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
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"NDC11Code": "71209-0087-01",
"ProductNDC": "71209-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211323",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
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"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
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"IndicationAndUsage": "Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:.",
"Description": "Venlafaxine extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended- release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. Tablets contain venlafaxine hydrochloride, USP equivalent to 75 mg, 150 mg and 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, magnesium stearate, hypromellose and microcrystalline cellulose. Imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac. Film-coating material contains ammonium hydroxide, ethyl cellulose 20cP, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, propylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "71209-087-04",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (71209-087-04) ",
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"ProductNDC": "71209-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
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"ApplicationNumber": "ANDA211323",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
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"IndicationAndUsage": "Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:.",
"Description": "Venlafaxine extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended- release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. Tablets contain venlafaxine hydrochloride, USP equivalent to 75 mg, 150 mg and 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, magnesium stearate, hypromellose and microcrystalline cellulose. Imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac. Film-coating material contains ammonium hydroxide, ethyl cellulose 20cP, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, propylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "71209-087-11",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (71209-087-11) ",
"NDC11Code": "71209-0087-11",
"ProductNDC": "71209-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
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"RouteName": "ORAL",
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"ApplicationNumber": "ANDA211323",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-02",
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"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:.",
"Description": "Venlafaxine extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended- release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. Tablets contain venlafaxine hydrochloride, USP equivalent to 75 mg, 150 mg and 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, magnesium stearate, hypromellose and microcrystalline cellulose. Imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac. Film-coating material contains ammonium hydroxide, ethyl cellulose 20cP, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, propylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "51285-040-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-040-01) ",
"NDC11Code": "51285-0040-01",
"ProductNDC": "51285-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziac",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931026",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020186",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931026",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.",
"Description": "ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide."
},
{
"NDCCode": "51285-047-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (51285-047-02) ",
"NDC11Code": "51285-0047-02",
"ProductNDC": "51285-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziac",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931026",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020186",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "2.5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931026",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.",
"Description": "ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide."
},
{
"NDCCode": "51285-050-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (51285-050-02) ",
"NDC11Code": "51285-0050-02",
"ProductNDC": "51285-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziac",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931026",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020186",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931026",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.",
"Description": "ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide."
},
{
"NDCCode": "51285-060-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-060-01)",
"NDC11Code": "51285-0060-01",
"ProductNDC": "51285-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zebeta",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931020",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019982",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "51285-061-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-061-01)",
"NDC11Code": "51285-0061-01",
"ProductNDC": "51285-061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zebeta",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931029",
"EndMarketingDate": "20170531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019982",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "51285-063-90",
"PackageDescription": "6 POUCH in 1 CARTON (51285-063-90) / 1 BLISTER PACK in 1 POUCH (51285-063-89) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0063-90",
"ProductNDC": "51285-063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prefest",
"NonProprietaryName": "Estradiol/norgestimate",
"DosageFormName": "KIT",
"StartMarketingDate": "20060530",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076812",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060530",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "PREFEST is indicated in women who have a uterus for 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 prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.",
"Description": "The PREFEST® regimen provides for a single oral tablet to be taken once daily. The peach tablet containing 1 mg estradiol, USP is taken on days one through three of therapy; the white tablet containing 1 mg estradiol, USP and 0.09 mg norgestimate, USP is taken on days four through six of therapy. This pattern is then repeated continuously to produce the constant estrogen/intermittent progestogen regimen of PREFEST. The estrogenic component of PREFEST is estradiol, USP. It is a white, crystalline solid, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The progestational component of PREFEST is micronized norgestimate, USP a white powder which is chemically described as 18,19-dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-. It has an empirical formula of C23H31NO3 and a molecular weight of 369.50. The structural formula is. Each tablet for oral administration contains 1 mg estradiol, USP alone or 1 mg estradiol, USP and 0.09 mg of norgestimate, USP. The inactive ingredients are as follows. The estradiol, USP tablet contains anhydrous lactose, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, magnesium stearate and microcrystalline cellulose. The estradiol and norgestimate tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "51285-079-97",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (51285-079-97) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0079-97",
"ProductNDC": "51285-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin 1/20",
"ProprietaryNameSuffix": "21 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076380",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1; 20",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-080-70",
"PackageDescription": "5 POUCH in 1 CARTON (51285-080-70) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0080-70",
"ProductNDC": "51285-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin Fe 1/20",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076081",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-081-98",
"PackageDescription": "30 POUCH in 1 CARTON (51285-081-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0081-98",
"ProductNDC": "51285-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin Fe 1/20",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076081",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-082-97",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (51285-082-97) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0082-97",
"ProductNDC": "51285-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin 1.5/30",
"ProprietaryNameSuffix": "21 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076381",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1.5; 30",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-083-70",
"PackageDescription": "5 POUCH in 1 CARTON (51285-083-70) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0083-70",
"ProductNDC": "51285-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin Fe 1.5/30",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076064",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-084-98",
"PackageDescription": "30 POUCH in 1 CARTON (51285-084-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0084-98",
"ProductNDC": "51285-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin Fe 1.5/30",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076064",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-100-88",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-100-88) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0100-88",
"ProductNDC": "51285-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Take Action",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140217",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021998",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140217",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "51285-103-88",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-103-88) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0103-88",
"ProductNDC": "51285-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aftera",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141020",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021998",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141020",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "51285-114-58",
"PackageDescription": "6 POUCH in 1 CARTON (51285-114-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0114-58",
"ProductNDC": "51285-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mircette",
"NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20090924",
"EndMarketingDate": "20150731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075863",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-08-07"
},
{
"NDCCode": "51285-120-58",
"PackageDescription": "6 POUCH in 1 CARTON (51285-120-58) / 1 BLISTER PACK in 1 POUCH (51285-120-79) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0120-58",
"ProductNDC": "51285-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mircette",
"NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20140915",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075863",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140915",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides.",
"Description": "Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Mircette also contains 5 yellow, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, polyethylene glycol, povidone, polysorbate 80, pregelatinized corn starch, stearic acid, titanium dioxide and vitamin E. The structural formulas are as follows. DESOGESTREL. C22H30O M.W. 310.48ETHINYL ESTRADIOL, USP. C20H24O2 M.W. 296.40. The 21 white tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51285-124-88",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-124-88) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0124-88",
"ProductNDC": "51285-124",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Plan B One-step",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131101",
"EndMarketingDate": "20170630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021998",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>51285-087-87</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (51285-087-87) / 1 BLISTER PACK in 1 POUCH (51285-087-82) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0087-87</NDC11Code>
<ProductNDC>51285-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Seasonique</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060710</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021840</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060710</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>SEASONIQUE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-092-87</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (51285-092-87) / 1 BLISTER PACK in 1 POUCH (51285-092-82) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0092-87</NDC11Code>
<ProductNDC>51285-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loseasonique</ProprietaryName>
<NonProprietaryName>Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090323</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022262</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090323</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOSEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>LOSEASONIQUE (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-431-87</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (51285-431-87) / 1 KIT in 1 POUCH</PackageDescription>
<NDC11Code>51285-0431-87</NDC11Code>
<ProductNDC>51285-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quartette</ProprietaryName>
<NonProprietaryName>Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130725</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204061</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170410</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>QUARTETTE® is indicated for use by females of reproductive age to prevent pregnancy.</IndicationAndUsage>
<Description>QUARTETTE (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets is an extended-cycle oral contraceptive. QUARTETTE consists of 42 light pink tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 pink tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol, and 21 purple tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen. The structural formulas, molecular formulas, molecular weights, and chemical names for the active components are shown below. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-(17α)- (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light pink tablet contains the following inactive ingredients:. anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide, and triacetin. Each pink tablet contains the following inactive ingredients:. anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin. Each purple tablet contains the following inactive ingredients:. anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 1/Brilliant Blue FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients. anhydrous lactose, D&C Yellow no. 10 aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol/macrogol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53329-087-87</NDCCode>
<PackageDescription>.9 g in 1 PACKET (53329-087-87) </PackageDescription>
<NDC11Code>53329-0087-87</NDC11Code>
<ProductNDC>53329-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Medline Industries, LP</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53329-087-96</NDCCode>
<PackageDescription>144 PACKET in 1 BOX (53329-087-96) / .9 g in 1 PACKET (53329-087-87) </PackageDescription>
<NDC11Code>53329-0087-96</NDC11Code>
<ProductNDC>53329-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Medline Industries, LP</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62217-087-87</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PUMP (62217-087-87) </PackageDescription>
<NDC11Code>62217-0087-87</NDC11Code>
<ProductNDC>62217-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fruit Of The Earth Honeysuckle Scented Antibacterial Hand With Canadian Willowherb</ProprietaryName>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210412</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>FRUIT OF THE EARTH, INC.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps reduce bacteria on hands.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-087-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-087-30)</PackageDescription>
<NDC11Code>16590-0087-30</NDC11Code>
<ProductNDC>16590-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23). Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of panic disorder, 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. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, 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 Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-087-56</NDCCode>
<PackageDescription>56 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-087-56)</PackageDescription>
<NDC11Code>16590-0087-56</NDC11Code>
<ProductNDC>16590-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Stat Rx USA</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23). Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of panic disorder, 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. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, 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 Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
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<IndicationAndUsage>Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23). Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of panic disorder, 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. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, 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 Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
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<IndicationAndUsage>Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23). Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials). Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Effexor XR is indicated for the treatment of panic disorder, 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. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, 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 Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
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<IndicationAndUsage>Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:.</IndicationAndUsage>
<Description>Venlafaxine extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended- release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. Tablets contain venlafaxine hydrochloride, USP equivalent to 75 mg, 150 mg and 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, magnesium stearate, hypromellose and microcrystalline cellulose. Imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac. Film-coating material contains ammonium hydroxide, ethyl cellulose 20cP, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, propylene glycol, talc and titanium dioxide.</Description>
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<IndicationAndUsage>Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:.</IndicationAndUsage>
<Description>Venlafaxine extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended- release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. Tablets contain venlafaxine hydrochloride, USP equivalent to 75 mg, 150 mg and 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, magnesium stearate, hypromellose and microcrystalline cellulose. Imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac. Film-coating material contains ammonium hydroxide, ethyl cellulose 20cP, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, propylene glycol, talc and titanium dioxide.</Description>
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<IndicationAndUsage>Venlafaxine extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:.</IndicationAndUsage>
<Description>Venlafaxine extended-release tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, USP a structurally novel antidepressant. Venlafaxine hydrochloride, USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine extended- release tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. Tablets contain venlafaxine hydrochloride, USP equivalent to 75 mg, 150 mg and 225 mg venlafaxine. Inactive ingredients consist of colloidal silicon dioxide, magnesium stearate, hypromellose and microcrystalline cellulose. Imprinting ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac. Film-coating material contains ammonium hydroxide, ethyl cellulose 20cP, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol, propylene glycol, talc and titanium dioxide.</Description>
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<StartMarketingDatePackage>19931026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.</IndicationAndUsage>
<Description>ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-047-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (51285-047-02) </PackageDescription>
<NDC11Code>51285-0047-02</NDC11Code>
<ProductNDC>51285-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziac</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931026</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020186</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>2.5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.</IndicationAndUsage>
<Description>ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-050-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (51285-050-02) </PackageDescription>
<NDC11Code>51285-0050-02</NDC11Code>
<ProductNDC>51285-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziac</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931026</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020186</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.</IndicationAndUsage>
<Description>ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-060-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-060-01)</PackageDescription>
<NDC11Code>51285-0060-01</NDC11Code>
<ProductNDC>51285-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zebeta</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931020</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019982</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-061-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-061-01)</PackageDescription>
<NDC11Code>51285-0061-01</NDC11Code>
<ProductNDC>51285-061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zebeta</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931029</StartMarketingDate>
<EndMarketingDate>20170531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019982</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-063-90</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (51285-063-90) / 1 BLISTER PACK in 1 POUCH (51285-063-89) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0063-90</NDC11Code>
<ProductNDC>51285-063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prefest</ProprietaryName>
<NonProprietaryName>Estradiol/norgestimate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060530</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076812</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060530</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREFEST is indicated in women who have a uterus for 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 prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.</IndicationAndUsage>
<Description>The PREFEST® regimen provides for a single oral tablet to be taken once daily. The peach tablet containing 1 mg estradiol, USP is taken on days one through three of therapy; the white tablet containing 1 mg estradiol, USP and 0.09 mg norgestimate, USP is taken on days four through six of therapy. This pattern is then repeated continuously to produce the constant estrogen/intermittent progestogen regimen of PREFEST. The estrogenic component of PREFEST is estradiol, USP. It is a white, crystalline solid, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The progestational component of PREFEST is micronized norgestimate, USP a white powder which is chemically described as 18,19-dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-. It has an empirical formula of C23H31NO3 and a molecular weight of 369.50. The structural formula is. Each tablet for oral administration contains 1 mg estradiol, USP alone or 1 mg estradiol, USP and 0.09 mg of norgestimate, USP. The inactive ingredients are as follows. The estradiol, USP tablet contains anhydrous lactose, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, magnesium stearate and microcrystalline cellulose. The estradiol and norgestimate tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>51285-079-97</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (51285-079-97) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0079-97</NDC11Code>
<ProductNDC>51285-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin 1/20</ProprietaryName>
<ProprietaryNameSuffix>21 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076380</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1; 20</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-080-70</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51285-080-70) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0080-70</NDC11Code>
<ProductNDC>51285-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin Fe 1/20</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076081</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-081-98</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (51285-081-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0081-98</NDC11Code>
<ProductNDC>51285-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin Fe 1/20</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076081</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-082-97</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (51285-082-97) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0082-97</NDC11Code>
<ProductNDC>51285-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin 1.5/30</ProprietaryName>
<ProprietaryNameSuffix>21 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076381</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1.5; 30</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-083-70</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51285-083-70) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0083-70</NDC11Code>
<ProductNDC>51285-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin Fe 1.5/30</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076064</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-084-98</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (51285-084-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0084-98</NDC11Code>
<ProductNDC>51285-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin Fe 1.5/30</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076064</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-100-88</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-100-88) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0100-88</NDC11Code>
<ProductNDC>51285-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Take Action</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140217</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021998</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140217</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51285-103-88</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-103-88) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0103-88</NDC11Code>
<ProductNDC>51285-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aftera</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141020</StartMarketingDate>
<EndMarketingDate>20200531</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021998</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141020</StartMarketingDatePackage>
<EndMarketingDatePackage>20200531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51285-114-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (51285-114-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0114-58</NDC11Code>
<ProductNDC>51285-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mircette</ProprietaryName>
<NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090924</StartMarketingDate>
<EndMarketingDate>20150731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075863</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-08-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-120-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (51285-120-58) / 1 BLISTER PACK in 1 POUCH (51285-120-79) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0120-58</NDC11Code>
<ProductNDC>51285-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mircette</ProprietaryName>
<NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140915</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075863</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140915</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides.</IndicationAndUsage>
<Description>Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Mircette also contains 5 yellow, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, polyethylene glycol, povidone, polysorbate 80, pregelatinized corn starch, stearic acid, titanium dioxide and vitamin E. The structural formulas are as follows. DESOGESTREL. C22H30O M.W. 310.48ETHINYL ESTRADIOL, USP. C20H24O2 M.W. 296.40. The 21 white tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51285-124-88</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-124-88) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0124-88</NDC11Code>
<ProductNDC>51285-124</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Plan B One-step</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<EndMarketingDate>20170630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021998</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
</NDCList>