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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20120501",
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{
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230914",
"SamplePackage": "N",
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"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "The Procter & Gamble Manufacturing Company",
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"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites."
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{
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"PackageDescription": "1 KIT in 1 CARTON (84126-220-01) * 28 DISC in 1 JAR * 56.7 g in 1 TUBE (84126-203-56) * 56.7 g in 1 TUBE",
"NDC11Code": "84126-0220-01",
"ProductNDC": "84126-220",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Beauty Dry Skin Rescue Kit",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to exzema rashes poison ivy, oak or sumac insect bites."
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{
"NDCCode": "84126-262-01",
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"NDC11Code": "84126-0262-01",
"ProductNDC": "84126-262",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Beauty Sensitive Skin Bestsellers Kit",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to exzema rashes poison ivy, oak or sumac insect bites."
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{
"NDCCode": "84126-911-01",
"PackageDescription": "1 KIT in 1 CARTON (84126-911-01) * 113 g in 1 TUBE (84126-203-11) * 28 DISC in 1 JAR * 170.1 g in 1 TUBE * 56.7 g in 1 TUBE",
"NDC11Code": "84126-0911-01",
"ProductNDC": "84126-911",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Beauty Face And Body Bestsellers Kit",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20260815",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to exzema rashes poison ivy, oak or sumac insect bites."
},
{
"NDCCode": "42337-203-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42337-203-01) ",
"NDC11Code": "42337-0203-01",
"ProductNDC": "42337-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076882",
"LabelerName": "Viwit Pharmaceutical Co., Ltd.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210228",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "42337-203-02",
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"ProductNDC": "42337-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076882",
"LabelerName": "Viwit Pharmaceutical Co., Ltd.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210228",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "42337-203-03",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42337-203-03) ",
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"ProductNDC": "42337-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076882",
"LabelerName": "Viwit Pharmaceutical Co., Ltd.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210228",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "42337-203-04",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (42337-203-04) ",
"NDC11Code": "42337-0203-04",
"ProductNDC": "42337-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076882",
"LabelerName": "Viwit Pharmaceutical Co., Ltd.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210228",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "42337-203-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42337-203-05) ",
"NDC11Code": "42337-0203-05",
"ProductNDC": "42337-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076882",
"LabelerName": "Viwit Pharmaceutical Co., Ltd.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210228",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "51495-203-01",
"PackageDescription": "25 kg in 1 DRUM (51495-203-01) ",
"NDC11Code": "51495-0203-01",
"ProductNDC": "51495-203",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Amino Acid Mixture Blend F",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170120",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Ajinomoto Health & Nutrition North America Inc.",
"SubstanceName": "GLYCINE; LEUCINE; METHIONINE; ISOLEUCINE; VALINE; ALANINE; ARGININE; HISTIDINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; PROLINE",
"StrengthNumber": "4.56; 9.1; 7.6; 7.6; 12.45; 8.5; 9.55; 6.4; 5.1; 8.5; 4.56; 5.75; 2.42; 2.69; 5.3",
"StrengthUnit": "kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20-JAN-17"
},
{
"NDCCode": "51495-203-02",
"PackageDescription": "25 kg in 1 DRUM (51495-203-02) ",
"NDC11Code": "51495-0203-02",
"ProductNDC": "51495-203",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Amino Acid Mixture Blend F",
"DosageFormName": "POWDER",
"StartMarketingDate": "20221001",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Ajinomoto Health & Nutrition North America Inc.",
"SubstanceName": "ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": "8.5; 9.55; 4.56; 6.4; 7.6; 9.1; 8.5; 7.6; 5.1; 5.3; 4.56; 5.75; 2.42; 2.69; 12.45",
"StrengthUnit": "kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-OCT-22"
},
{
"NDCCode": "69945-120-56",
"PackageDescription": "1 VIAL in 1 CAN (69945-120-56) / 5.6 mL in 1 VIAL",
"NDC11Code": "69945-0120-56",
"ProductNDC": "69945-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thallous Chloride Tl 201",
"NonProprietaryName": "Thallous Chloride, Tl 201",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018150",
"LabelerName": "Curium US LLC",
"SubstanceName": "THALLOUS CHLORIDE TL-201",
"StrengthNumber": "1",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151104",
"SamplePackage": "N",
"IndicationAndUsage": "Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: 1 Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction)Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress, 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels.",
"Description": "Thallous Chloride Tl 201 Injection is a sterile, radioactive diagnostic drug for intravenous use. Each mL contains 37 MBq (1 mCi) thallous chloride Tl 201 at calibration time and the following inactive ingredients: 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium-201 is cyclotron produced. At the time of calibration it contains no more than 1% thallium-200, no more than 1% thallium-202, no more than 0.25% lead-203, and no less than 98% thallium-201 as a percentage of total activity. No carrier has been added. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of thallium-200 (Tl 200) and thallium-202 (Tl 202) radionuclidic contaminants as a function of time. Figure 1. Radionuclidic Contaminants."
},
{
"NDCCode": "70010-203-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70010-203-03) ",
"NDC11Code": "70010-0203-03",
"ProductNDC": "70010-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078403",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3."
},
{
"NDCCode": "70010-203-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (70010-203-05) ",
"NDC11Code": "70010-0203-05",
"ProductNDC": "70010-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078403",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3."
},
{
"NDCCode": "70010-203-09",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70010-203-09) ",
"NDC11Code": "70010-0203-09",
"ProductNDC": "70010-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078403",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3."
},
{
"NDCCode": "70010-203-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (70010-203-10) ",
"NDC11Code": "70010-0203-10",
"ProductNDC": "70010-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078403",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3."
},
{
"NDCCode": "70010-203-50",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (70010-203-50) ",
"NDC11Code": "70010-0203-50",
"ProductNDC": "70010-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078403",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3."
},
{
"NDCCode": "70010-203-53",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE (70010-203-53) ",
"NDC11Code": "70010-0203-53",
"ProductNDC": "70010-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078403",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3."
},
{
"NDCCode": "70010-203-63",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (70010-203-63) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70010-0203-63",
"ProductNDC": "70010-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078403",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230515",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3."
},
{
"NDCCode": "0065-0343-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0343-02",
"ProductNDC": "0065-0343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207926",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
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<StartMarketingDatePackage>20210228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42337-203-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42337-203-02) </PackageDescription>
<NDC11Code>42337-0203-02</NDC11Code>
<ProductNDC>42337-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076882</ApplicationNumber>
<LabelerName>Viwit Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42337-203-03</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42337-203-03) </PackageDescription>
<NDC11Code>42337-0203-03</NDC11Code>
<ProductNDC>42337-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076882</ApplicationNumber>
<LabelerName>Viwit Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42337-203-04</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (42337-203-04) </PackageDescription>
<NDC11Code>42337-0203-04</NDC11Code>
<ProductNDC>42337-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076882</ApplicationNumber>
<LabelerName>Viwit Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42337-203-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42337-203-05) </PackageDescription>
<NDC11Code>42337-0203-05</NDC11Code>
<ProductNDC>42337-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076882</ApplicationNumber>
<LabelerName>Viwit Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline Hydrochloride Tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline Hydrochloride Tablets contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2∙HCl is represented by the following structural formula:. Sertraline hydrochloride is a white or off-white crystalline powder that is sparingly soluble in methanol, in dimethyl formamide and in absolute alcohol; slightly soluble in water and in isopropanol. Sertraline Hydrochloride Tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, yellow iron oxide (in 25 mg and 100 mg tablets), methylcellulose, colloidal silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51495-203-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (51495-203-01) </PackageDescription>
<NDC11Code>51495-0203-01</NDC11Code>
<ProductNDC>51495-203</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Amino Acid Mixture Blend F</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170120</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Ajinomoto Health & Nutrition North America Inc.</LabelerName>
<SubstanceName>GLYCINE; LEUCINE; METHIONINE; ISOLEUCINE; VALINE; ALANINE; ARGININE; HISTIDINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; PROLINE</SubstanceName>
<StrengthNumber>4.56; 9.1; 7.6; 7.6; 12.45; 8.5; 9.55; 6.4; 5.1; 8.5; 4.56; 5.75; 2.42; 2.69; 5.3</StrengthNumber>
<StrengthUnit>kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-JAN-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51495-203-02</NDCCode>
<PackageDescription>25 kg in 1 DRUM (51495-203-02) </PackageDescription>
<NDC11Code>51495-0203-02</NDC11Code>
<ProductNDC>51495-203</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Amino Acid Mixture Blend F</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20221001</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Ajinomoto Health & Nutrition North America Inc.</LabelerName>
<SubstanceName>ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>8.5; 9.55; 4.56; 6.4; 7.6; 9.1; 8.5; 7.6; 5.1; 5.3; 4.56; 5.75; 2.42; 2.69; 12.45</StrengthNumber>
<StrengthUnit>kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg; kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-OCT-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69945-120-56</NDCCode>
<PackageDescription>1 VIAL in 1 CAN (69945-120-56) / 5.6 mL in 1 VIAL</PackageDescription>
<NDC11Code>69945-0120-56</NDC11Code>
<ProductNDC>69945-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thallous Chloride Tl 201</ProprietaryName>
<NonProprietaryName>Thallous Chloride, Tl 201</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018150</ApplicationNumber>
<LabelerName>Curium US LLC</LabelerName>
<SubstanceName>THALLOUS CHLORIDE TL-201</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: 1 Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction)Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress, 2 Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels.</IndicationAndUsage>
<Description>Thallous Chloride Tl 201 Injection is a sterile, radioactive diagnostic drug for intravenous use. Each mL contains 37 MBq (1 mCi) thallous chloride Tl 201 at calibration time and the following inactive ingredients: 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol. The pH is adjusted to between 4.5 to 7.0 with hydrochloric acid and/or sodium hydroxide. Thallium-201 is cyclotron produced. At the time of calibration it contains no more than 1% thallium-200, no more than 1% thallium-202, no more than 0.25% lead-203, and no less than 98% thallium-201 as a percentage of total activity. No carrier has been added. The concentration of each radionuclidic contaminant changes with time. Figure 1 shows maximum concentration of thallium-200 (Tl 200) and thallium-202 (Tl 202) radionuclidic contaminants as a function of time. Figure 1. Radionuclidic Contaminants.</Description>
</NDC>
<NDC>
<NDCCode>70010-203-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70010-203-03) </PackageDescription>
<NDC11Code>70010-0203-03</NDC11Code>
<ProductNDC>70010-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078403</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>70010-203-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (70010-203-05) </PackageDescription>
<NDC11Code>70010-0203-05</NDC11Code>
<ProductNDC>70010-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078403</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>70010-203-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70010-203-09) </PackageDescription>
<NDC11Code>70010-0203-09</NDC11Code>
<ProductNDC>70010-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078403</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3.</Description>
</NDC>
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<NDCCode>70010-203-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (70010-203-10) </PackageDescription>
<NDC11Code>70010-0203-10</NDC11Code>
<ProductNDC>70010-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078403</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3.</Description>
</NDC>
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<NDCCode>70010-203-50</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (70010-203-50) </PackageDescription>
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<ProductNDC>70010-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078403</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>70010-203-53</NDCCode>
<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE (70010-203-53) </PackageDescription>
<NDC11Code>70010-0203-53</NDC11Code>
<ProductNDC>70010-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078403</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>70010-203-63</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (70010-203-63) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70010-0203-63</NDC11Code>
<ProductNDC>70010-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078403</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies (14)]: Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>0065-0343-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0343-02</NDC11Code>
<ProductNDC>0065-0343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>0065-0349-04</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0349-04) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0349-04</NDC11Code>
<ProductNDC>0065-0349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>0065-0349-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0349-05) / 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0349-05</NDC11Code>
<ProductNDC>0065-0349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
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