{
"NDC": [
{
"NDCCode": "69117-0026-5",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0026-5) ",
"NDC11Code": "69117-0026-05",
"ProductNDC": "69117-0026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211248",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2."
},
{
"NDCCode": "69117-0026-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0026-1) ",
"NDC11Code": "69117-0026-01",
"ProductNDC": "69117-0026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211248",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2."
},
{
"NDCCode": "69117-0026-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0026-2) ",
"NDC11Code": "69117-0026-02",
"ProductNDC": "69117-0026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211248",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2."
},
{
"NDCCode": "69117-0026-3",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0026-3) ",
"NDC11Code": "69117-0026-03",
"ProductNDC": "69117-0026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211248",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2."
},
{
"NDCCode": "69117-0026-4",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0026-4) ",
"NDC11Code": "69117-0026-04",
"ProductNDC": "69117-0026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211248",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2."
},
{
"NDCCode": "69117-0012-5",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69117-0012-5) ",
"NDC11Code": "69117-0012-05",
"ProductNDC": "69117-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208920",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210304",
"SamplePackage": "N"
},
{
"NDCCode": "69117-0014-5",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69117-0014-5) ",
"NDC11Code": "69117-0014-05",
"ProductNDC": "69117-0014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208920",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210304",
"SamplePackage": "N"
},
{
"NDCCode": "69117-0015-5",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69117-0015-5) ",
"NDC11Code": "69117-0015-05",
"ProductNDC": "69117-0015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208920",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210304",
"SamplePackage": "N"
},
{
"NDCCode": "69117-0024-5",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-5) ",
"NDC11Code": "69117-0024-05",
"ProductNDC": "69117-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211248",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2."
},
{
"NDCCode": "69117-0025-5",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0025-5) ",
"NDC11Code": "69117-0025-05",
"ProductNDC": "69117-0025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211248",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2."
},
{
"NDCCode": "69117-0027-5",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0027-5) ",
"NDC11Code": "69117-0027-05",
"ProductNDC": "69117-0027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211248",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211102",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2."
},
{
"NDCCode": "69117-0036-5",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69117-0036-5) ",
"NDC11Code": "69117-0036-05",
"ProductNDC": "69117-0036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212041",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) Adjunct therapy for heart failure (1.2) Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate. Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide."
},
{
"NDCCode": "69117-0037-5",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69117-0037-5) ",
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"ProductNDC": "69117-0037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212041",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) Adjunct therapy for heart failure (1.2) Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate. Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide."
},
{
"NDCCode": "69117-0038-5",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69117-0038-5) ",
"NDC11Code": "69117-0038-05",
"ProductNDC": "69117-0038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212041",
"LabelerName": "Yiling Pharmaceutical, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) Adjunct therapy for heart failure (1.2) Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate. Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide."
},
{
"NDCCode": "0009-0026-01",
"PackageDescription": "1 BAG in 1 CONTAINER (0009-0026-01) > 1.5 kg in 1 BAG",
"NDC11Code": "00009-0026-01",
"ProductNDC": "0009-0026",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Methylprednisolone Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140703",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pharmacia and Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2020-11-25",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "0026-3782-20",
"PackageDescription": "1 KIT in 1 BOX (0026-3782-20) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01) * 2.5 mL in 1 VIAL (0026-0425-02)",
"NDC11Code": "00026-3782-20",
"ProductNDC": "0026-3782",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20000626",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3782-25",
"PackageDescription": "1 KIT in 1 BOX (0026-3782-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) ",
"NDC11Code": "00026-3782-25",
"ProductNDC": "0026-3782",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20130626",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130626",
"SamplePackage": "N",
"IndicationAndUsage": "Kogenate® FS is a recombinant antihemophilic factor indicated for: 1 On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. , 2 Perioperative management of bleeding in adults and children with hemophilia A. , 3 Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage., 4 Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.",
"Description": "Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product."
},
{
"NDCCode": "0026-3783-30",
"PackageDescription": "1 KIT in 1 BOX (0026-3783-30) * 2.5 mL in 1 VIAL (0026-0425-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4783-01)",
"NDC11Code": "00026-3783-30",
"ProductNDC": "0026-3783",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20000626",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3783-35",
"PackageDescription": "1 KIT in 1 BOX (0026-3783-35) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4783-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) ",
"NDC11Code": "00026-3783-35",
"ProductNDC": "0026-3783",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20130626",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130626",
"SamplePackage": "N",
"IndicationAndUsage": "Kogenate® FS is a recombinant antihemophilic factor indicated for: 1 On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. , 2 Perioperative management of bleeding in adults and children with hemophilia A. , 3 Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage., 4 Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.",
"Description": "Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product."
},
{
"NDCCode": "0026-3785-50",
"PackageDescription": "1 KIT in 1 BOX (0026-3785-50) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4785-01) * 2.5 mL in 1 VIAL (0026-0425-02)",
"NDC11Code": "00026-3785-50",
"ProductNDC": "0026-3785",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20000626",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3785-55",
"PackageDescription": "1 KIT in 1 BOX (0026-3785-55) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4785-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) ",
"NDC11Code": "00026-3785-55",
"ProductNDC": "0026-3785",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20130626",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130626",
"SamplePackage": "N",
"IndicationAndUsage": "Kogenate® FS is a recombinant antihemophilic factor indicated for: 1 On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. , 2 Perioperative management of bleeding in adults and children with hemophilia A. , 3 Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage., 4 Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.",
"Description": "Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product."
},
{
"NDCCode": "0026-3786-60",
"PackageDescription": "1 KIT in 1 BOX (0026-3786-60) * 5 mL in 1 VIAL, SINGLE-USE (0026-4786-01) * 5 mL in 1 VIAL (0026-0426-50)",
"NDC11Code": "00026-3786-60",
"ProductNDC": "0026-3786",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20070607",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3786-65",
"PackageDescription": "1 KIT in 1 BOX (0026-3786-65) * 5 mL in 1 VIAL, SINGLE-USE (0026-4786-01) * 5 mL in 1 SYRINGE (0026-0426-05) ",
"NDC11Code": "00026-3786-65",
"ProductNDC": "0026-3786",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20130626",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130626",
"SamplePackage": "N",
"IndicationAndUsage": "Kogenate® FS is a recombinant antihemophilic factor indicated for: 1 On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. , 2 Perioperative management of bleeding in adults and children with hemophilia A. , 3 Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage., 4 Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.",
"Description": "Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product."
},
{
"NDCCode": "0026-3787-70",
"PackageDescription": "1 KIT in 1 BOX (0026-3787-70) * 5 mL in 1 VIAL, SINGLE-USE (0026-4787-01) * 5 mL in 1 VIAL (0026-0426-50)",
"NDC11Code": "00026-3787-70",
"ProductNDC": "0026-3787",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3787-75",
"PackageDescription": "1 KIT in 1 BOX (0026-3787-75) * 5 mL in 1 VIAL, SINGLE-USE (0026-4787-01) * 5 mL in 1 SYRINGE (0026-0426-05) ",
"NDC11Code": "00026-3787-75",
"ProductNDC": "0026-3787",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20130626",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130626",
"SamplePackage": "N",
"IndicationAndUsage": "Kogenate® FS is a recombinant antihemophilic factor indicated for: 1 On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. , 2 Perioperative management of bleeding in adults and children with hemophilia A. , 3 Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage., 4 Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.",
"Description": "Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product."
},
{
"NDCCode": "0026-3792-20",
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"NDC11Code": "00026-3792-20",
"ProductNDC": "0026-3792",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20051117",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3793-30",
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"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20051117",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3795-50",
"PackageDescription": "1 KIT in 1 BOX (0026-3795-50) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4795-01) * 2.5 mL in 1 SYRINGE (0026-0426-02)",
"NDC11Code": "00026-3795-50",
"ProductNDC": "0026-3795",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20051117",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3796-60",
"PackageDescription": "1 KIT in 1 BOX (0026-3796-60) * 5 mL in 1 VIAL, SINGLE-USE (0026-4796-01) * 5 mL in 1 SYRINGE (0026-0426-05)",
"NDC11Code": "00026-3796-60",
"ProductNDC": "0026-3796",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20080704",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0026-3797-70",
"PackageDescription": "1 KIT in 1 BOX (0026-3797-70) * 5 mL in 1 VIAL, SINGLE-USE (0026-4797-01) * 5 mL in 1 SYRINGE (0026-0426-05)",
"NDC11Code": "00026-3797-70",
"ProductNDC": "0026-3797",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Kogenate Fs",
"NonProprietaryName": "Antihemophilic Factor (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103332",
"LabelerName": "Bayer HealthCare LLC",
"Status": "Deprecated",
"LastUpdate": "2018-01-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
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<Description>Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2.</Description>
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<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0026-1) </PackageDescription>
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<Description>Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2.</Description>
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<ProductNDC>69117-0026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LastUpdate>2026-01-01</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<Description>Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2.</Description>
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<Description>Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2.</Description>
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<ApplicationNumber>ANDA211248</ApplicationNumber>
<LabelerName>Yiling Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2.</Description>
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<PackageDescription>1000 TABLET in 1 BOTTLE (69117-0012-5) </PackageDescription>
<NDC11Code>69117-0012-05</NDC11Code>
<ProductNDC>69117-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2023-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC11Code>69117-0014-05</NDC11Code>
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<LastUpdate>2023-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Yiling Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69117-0024-5</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0024-5) </PackageDescription>
<NDC11Code>69117-0024-05</NDC11Code>
<ProductNDC>69117-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211248</ApplicationNumber>
<LabelerName>Yiling Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69117-0025-5</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0025-5) </PackageDescription>
<NDC11Code>69117-0025-05</NDC11Code>
<ProductNDC>69117-0025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211248</ApplicationNumber>
<LabelerName>Yiling Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69117-0027-5</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69117-0027-5) </PackageDescription>
<NDC11Code>69117-0027-05</NDC11Code>
<ProductNDC>69117-0027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211248</ApplicationNumber>
<LabelerName>Yiling Pharmaceutical, Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine is indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120℃ to 138℃ and a solubility of 5.4 mg/mL in water. Tablets. Paroxetine tablets USP are for oral administration. Each film-coated tablet contains 10mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg paroxetine hydrochloride, respectively. Inactive ingredients in core tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, sodium starch glycolate. Inactive ingredients in the coating of 10 mg tablets: ferric oxide red, ferric oxide yellow, ferrosoferric oxide, hypromellose, maltodextrin, medium-chain triglycerides, polydextrose, talc, titanium dioxide. Inactive ingredients in the coating of 20 mg tablets: ferric oxide red, hypromellose, polyethylene glycol, titanium dioxide. Inactive ingredients in the coating of 30 mg tablets: FD&C Blue No. 2 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide. Inactive ingredients in the coating of 40 mg tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, ferric oxide yellow, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. Complies with USP Chromatographic Purity Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69117-0036-5</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (69117-0036-5) </PackageDescription>
<NDC11Code>69117-0036-05</NDC11Code>
<ProductNDC>69117-0036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212041</ApplicationNumber>
<LabelerName>Yiling Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) Adjunct therapy for heart failure (1.2) Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate. Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>69117-0037-5</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (69117-0037-5) </PackageDescription>
<NDC11Code>69117-0037-05</NDC11Code>
<ProductNDC>69117-0037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212041</ApplicationNumber>
<LabelerName>Yiling Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) Adjunct therapy for heart failure (1.2) Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate. Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>69117-0038-5</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (69117-0038-5) </PackageDescription>
<NDC11Code>69117-0038-05</NDC11Code>
<ProductNDC>69117-0038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212041</ApplicationNumber>
<LabelerName>Yiling Pharmaceutical, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1) Adjunct therapy for heart failure (1.2) Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L- proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate. Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0009-0026-01</NDCCode>
<PackageDescription>1 BAG in 1 CONTAINER (0009-0026-01) > 1.5 kg in 1 BAG</PackageDescription>
<NDC11Code>00009-0026-01</NDC11Code>
<ProductNDC>0009-0026</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140703</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pharmacia and Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-11-25</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0026-3782-20</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3782-20) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01) * 2.5 mL in 1 VIAL (0026-0425-02)</PackageDescription>
<NDC11Code>00026-3782-20</NDC11Code>
<ProductNDC>0026-3782</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Kogenate Fs</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20000626</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103332</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-01-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0026-3782-25</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3782-25) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4782-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) </PackageDescription>
<NDC11Code>00026-3782-25</NDC11Code>
<ProductNDC>0026-3782</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Kogenate Fs</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130626</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103332</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kogenate® FS is a recombinant antihemophilic factor indicated for: 1 On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. , 2 Perioperative management of bleeding in adults and children with hemophilia A. , 3 Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage., 4 Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.</IndicationAndUsage>
<Description>Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product.</Description>
</NDC>
<NDC>
<NDCCode>0026-3783-30</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3783-30) * 2.5 mL in 1 VIAL (0026-0425-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4783-01)</PackageDescription>
<NDC11Code>00026-3783-30</NDC11Code>
<ProductNDC>0026-3783</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Kogenate Fs</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20000626</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103332</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-01-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0026-3783-35</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0026-3783-35) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4783-01) * 2.5 mL in 1 SYRINGE (0026-0426-02) </PackageDescription>
<NDC11Code>00026-3783-35</NDC11Code>
<ProductNDC>0026-3783</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Kogenate Fs</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130626</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103332</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Kogenate® FS is a recombinant antihemophilic factor indicated for: 1 On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. , 2 Perioperative management of bleeding in adults and children with hemophilia A. , 3 Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage., 4 Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.</IndicationAndUsage>
<Description>Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product.</Description>
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<IndicationAndUsage>Kogenate® FS is a recombinant antihemophilic factor indicated for: 1 On-demand treatment and control of bleeding episodes in adults and children with hemophilia A. , 2 Perioperative management of bleeding in adults and children with hemophilia A. , 3 Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage., 4 Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.</IndicationAndUsage>
<Description>Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product.</Description>
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<Description>Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product.</Description>
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<Description>Kogenate FS Antihemophilic Factor (Recombinant) is a coagulation factor VIII produced by recombinant DNA technology. It is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII gene has been introduced.14 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as factor VIII derived from human plasma. No human or animal proteins, such as albumin, are added during the purification and formulation processes of Kogenate FS. The purification process includes a solvent/detergent virus inactivation step in addition to the use of the purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant factor VIII and remove contaminating substances. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-19 Several of the individual production and raw material preparation steps in the Kogenate FS manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. These TSE reduction steps include the Fraction II+III separation step for HPPS (6.0 log10) and an anion exchange chromatography step (3.6 log10). Kogenate FS is formulated with the following as stabilizers (see Table 6) in the final container and is then lyophilized. The final product does not contain any preservative. It is a sterile, nonpyrogenic, powder preparation for intravenous injection. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels. Table 7 lists the inactive ingredients/excipients also contained in the final product.</Description>
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