{
"NDC": [
{
"NDCCode": "55494-580-18",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55494-0580-18",
"ProductNDC": "55494-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osphena",
"NonProprietaryName": "Ospemifene",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203505",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "OSPEMIFENE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230401",
"SamplePackage": "Y",
"IndicationAndUsage": "OSPHENA is indicated for.",
"Description": "OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24H 23ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "55494-580-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30) ",
"NDC11Code": "55494-0580-30",
"ProductNDC": "55494-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osphena",
"NonProprietaryName": "Ospemifene",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203505",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "OSPEMIFENE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "OSPHENA is indicated for.",
"Description": "OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24H 23ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "55494-580-55",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55494-0580-55",
"ProductNDC": "55494-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osphena",
"NonProprietaryName": "Ospemifene",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203505",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "OSPEMIFENE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230401",
"SamplePackage": "Y",
"IndicationAndUsage": "OSPHENA is indicated for.",
"Description": "OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24H 23ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "55494-580-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90) ",
"NDC11Code": "55494-0580-90",
"ProductNDC": "55494-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osphena",
"NonProprietaryName": "Ospemifene",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203505",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "OSPEMIFENE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230401",
"SamplePackage": "N",
"IndicationAndUsage": "OSPHENA is indicated for.",
"Description": "OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24H 23ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "43419-580-18",
"PackageDescription": "1 TUBE in 1 CARTON (43419-580-18) > 60 mL in 1 TUBE",
"NDC11Code": "43419-0580-18",
"ProductNDC": "43419-580",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amorepacific Natural Protector",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160118",
"EndMarketingDate": "20200530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1500; 5400; 2700; 5400",
"StrengthUnit": "mg/60mL; mg/60mL; mg/60mL; mg/60mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160118",
"EndMarketingDatePackage": "20200530",
"SamplePackage": "N"
},
{
"NDCCode": "59630-580-18",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE (59630-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59630-0580-18",
"ProductNDC": "59630-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osphena",
"NonProprietaryName": "Ospemifene",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130226",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203505",
"LabelerName": "Shionogi Inc.",
"SubstanceName": "OSPEMIFENE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170415",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "OSPHENA is indicated for.",
"Description": "OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C24H23ClO2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin."
},
{
"NDCCode": "50458-580-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (50458-580-07) ",
"NDC11Code": "50458-0580-07",
"ProductNDC": "50458-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xarelto",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022406",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "Y",
"IndicationAndUsage": "XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum."
},
{
"NDCCode": "50458-580-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (50458-580-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (50458-580-01) ",
"NDC11Code": "50458-0580-10",
"ProductNDC": "50458-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xarelto",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022406",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum."
},
{
"NDCCode": "50458-580-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50458-580-30) ",
"NDC11Code": "50458-0580-30",
"ProductNDC": "50458-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xarelto",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022406",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum."
},
{
"NDCCode": "50458-580-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50458-580-90) ",
"NDC11Code": "50458-0580-90",
"ProductNDC": "50458-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xarelto",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022406",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N",
"IndicationAndUsage": "XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum."
},
{
"NDCCode": "59310-580-20",
"PackageDescription": "1 INHALER in 1 BOX (59310-580-20) / 200 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0580-20",
"ProductNDC": "59310-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair Respiclick",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150423",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205636",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150511",
"SamplePackage": "N",
"IndicationAndUsage": "PROAIR RESPICLICK is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2).",
"Description": "The active ingredient of PROAIR RESPICLICK inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. PROAIR RESPICLICK is an inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, the PROAIR RESPICLICK inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 actuations (inhalations)."
},
{
"NDCCode": "59310-580-21",
"PackageDescription": "1 INHALER in 1 BOX (59310-580-21) > 200 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0580-21",
"ProductNDC": "59310-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair Respiclick",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150423",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205636",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150423",
"SamplePackage": "N",
"IndicationAndUsage": "PROAIR RESPICLICK is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2).",
"Description": "The active ingredient of PROAIR RESPICLICK inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. PROAIR RESPICLICK is an inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, the PROAIR RESPICLICK inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 actuations (inhalations)."
},
{
"NDCCode": "68084-580-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68084-580-01) > 10 TABLET in 1 BLISTER PACK (68084-580-11)",
"NDC11Code": "68084-0580-01",
"ProductNDC": "68084-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077031",
"LabelerName": "American Health Packaging",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "69654-580-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-580-30) ",
"NDC11Code": "69654-0580-30",
"ProductNDC": "69654-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metadate Cd",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021259",
"LabelerName": "Aytu BioPharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240222",
"SamplePackage": "N",
"IndicationAndUsage": "METADATE CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of METADATE CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7). Use in Specific Populations ( 8.4)] .",
"Description": "METADATE CD contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. METADATE CD is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d, l(racemic)- threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is:. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. METADATE CD also contains the following inactive ingredients: Dibutyl sebacate, ethylcellulose aqueous dispersion, gelatin, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sugar spheres, and titanium dioxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: FD&C Blue No. 2. 30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide. 40 mg capsules: FDA/E172 Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide."
},
{
"NDCCode": "72189-580-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (72189-580-60) ",
"NDC11Code": "72189-0580-60",
"ProductNDC": "72189-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Sublingual C-iii",
"NonProprietaryName": "Buprenorphine Sublingual C-iii",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20240916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078633",
"LabelerName": "Direct_Rx",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240916",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.",
"Description": "Buprenorphine Sublingual Tablets are supplied as white, sublingual tablets available in two dosage strengths, 2 mg buprenorphine free base and 8 mg buprenorphine free base. Each tablet also contains citric acid anhydrous, corn starch, crospovidone, lactose monohydrate, magnesium stearate, mannitol, povidone, purified water and sodium citrate. Chemically, buprenorphine hydrochloride, USP is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O-methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure. [chem-fig]. Buprenorphine hydrochloride, USP has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane, acetone, and ethylacetate."
},
{
"NDCCode": "72189-580-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (72189-580-90) ",
"NDC11Code": "72189-0580-90",
"ProductNDC": "72189-580",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Sublingual C-iii",
"NonProprietaryName": "Buprenorphine Sublingual C-iii",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20240916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078633",
"LabelerName": "Direct_Rx",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240916",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.",
"Description": "Buprenorphine Sublingual Tablets are supplied as white, sublingual tablets available in two dosage strengths, 2 mg buprenorphine free base and 8 mg buprenorphine free base. Each tablet also contains citric acid anhydrous, corn starch, crospovidone, lactose monohydrate, magnesium stearate, mannitol, povidone, purified water and sodium citrate. Chemically, buprenorphine hydrochloride, USP is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O-methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure. [chem-fig]. Buprenorphine hydrochloride, USP has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane, acetone, and ethylacetate."
},
{
"NDCCode": "55494-100-10",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) ",
"NDC11Code": "55494-0100-10",
"ProductNDC": "55494-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclegis",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021876",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130515",
"SamplePackage": "N",
"IndicationAndUsage": "DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.",
"Description": "DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-100-99",
"PackageDescription": "12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) ",
"NDC11Code": "55494-0100-99",
"ProductNDC": "55494-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclegis",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021876",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140328",
"SamplePackage": "Y",
"IndicationAndUsage": "DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.",
"Description": "DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-10",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10) ",
"NDC11Code": "55494-0120-10",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "N",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60) ",
"NDC11Code": "55494-0120-60",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "N",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-94",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55494-0120-94",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250226",
"SamplePackage": "Y",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "55494-120-99",
"PackageDescription": "6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99) ",
"NDC11Code": "55494-0120-99",
"ProductNDC": "55494-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bonjesta",
"NonProprietaryName": "Doxylamine Succinate And Pyridoxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209661",
"LabelerName": "Duchesnay USA, Inc.",
"SubstanceName": "DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180219",
"SamplePackage": "Y",
"IndicationAndUsage": "BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.",
"Description": "BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether."
},
{
"NDCCode": "0143-9533-01",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9533-01) > 25 mL in 1 VIAL",
"NDC11Code": "00143-9533-01",
"ProductNDC": "0143-9533",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol Sodium",
"NonProprietaryName": "Allopurinol Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076870",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ALLOPURINOL SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040901",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol Sodium for Injection is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.",
"Description": "Allopurinol Sodium for Injection, a xanthine oxidase inhibitor, is a sterile, white, lyophilized powder or cake, in a single-dose vial for reconstitution. Each vial contains 500 mg of allopurinol equivalent to 580.7 mg of allopurinol sodium and 162.5 mg of sodium hydroxide as a solubilizer. Sodium hydroxide is also used as a pH adjuster. Allopurinol Sodium for Injection contains no preservatives. Allopurinol is a xanthine oxidase inhibitor. The chemical name for allopurinol sodium is 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C5H3N4NaO. The structural formula is. The pKa of allopurinol sodium is 9.31."
},
{
"NDCCode": "0173-0922-38",
"PackageDescription": "8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) ",
"NDC11Code": "00173-0922-38",
"ProductNDC": "0173-0922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Blujepa",
"NonProprietaryName": "Gepotidacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250325",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218230",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "GEPOTIDACIN MESYLATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).",
"Description": "BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "0173-0922-45",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) ",
"NDC11Code": "00173-0922-45",
"ProductNDC": "0173-0922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Blujepa",
"NonProprietaryName": "Gepotidacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250325",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218230",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "GEPOTIDACIN MESYLATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250325",
"SamplePackage": "N",
"IndicationAndUsage": "BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).",
"Description": "BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "0338-0644-03",
"PackageDescription": "500 mL in 1 BAG (0338-0644-03) ",
"NDC11Code": "00338-0644-03",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0644-04",
"PackageDescription": "1000 mL in 1 BAG (0338-0644-04) ",
"NDC11Code": "00338-0644-04",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0644-06",
"PackageDescription": "2000 mL in 1 BAG (0338-0644-06) ",
"NDC11Code": "00338-0644-06",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-4210-02",
"PackageDescription": "1 KIT in 1 CARTON (0338-4210-02) * 1 mL in 1 VIAL, GLASS (0338-7112-01) * 1 mL in 1 VIAL, GLASS (0338-7332-01) * 1 mL in 1 VIAL, GLASS (0338-7201-01) * 1 mL in 1 VIAL, GLASS (0338-7401-01) ",
"NDC11Code": "00338-4210-02",
"ProductNDC": "0338-4210",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "KIT",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980501",
"SamplePackage": "N",
"IndicationAndUsage": "Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.",
"Description": "TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1 The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2 Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3 Thrombin Solution, 4 Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5 * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU)."
},
{
"NDCCode": "0338-4211-04",
"PackageDescription": "1 KIT in 1 CARTON (0338-4211-04) * 2 mL in 1 VIAL, GLASS (0338-7112-02) * 2 mL in 1 VIAL, GLASS (0338-7332-02) * 2 mL in 1 VIAL, GLASS (0338-7201-02) * 2 mL in 1 VIAL, GLASS (0338-7401-02) ",
"NDC11Code": "00338-4211-04",
"ProductNDC": "0338-4211",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Tisseel",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "KIT",
"StartMarketingDate": "19980501",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103980",
"LabelerName": "Baxter Healthcare Corporation",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980501",
"SamplePackage": "N",
"IndicationAndUsage": "Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.",
"Description": "TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1 The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2 Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3 Thrombin Solution, 4 Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5 * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU)."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>55494-580-18</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55494-0580-18</NDC11Code>
<ProductNDC>55494-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osphena</ProprietaryName>
<NonProprietaryName>Ospemifene</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203505</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>OSPEMIFENE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230401</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>OSPHENA is indicated for.</IndicationAndUsage>
<Description>OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24H 23ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>55494-580-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30) </PackageDescription>
<NDC11Code>55494-0580-30</NDC11Code>
<ProductNDC>55494-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osphena</ProprietaryName>
<NonProprietaryName>Ospemifene</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203505</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>OSPEMIFENE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OSPHENA is indicated for.</IndicationAndUsage>
<Description>OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24H 23ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>55494-580-55</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55494-0580-55</NDC11Code>
<ProductNDC>55494-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osphena</ProprietaryName>
<NonProprietaryName>Ospemifene</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203505</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>OSPEMIFENE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230401</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>OSPHENA is indicated for.</IndicationAndUsage>
<Description>OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24H 23ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>55494-580-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90) </PackageDescription>
<NDC11Code>55494-0580-90</NDC11Code>
<ProductNDC>55494-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osphena</ProprietaryName>
<NonProprietaryName>Ospemifene</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203505</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>OSPEMIFENE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OSPHENA is indicated for.</IndicationAndUsage>
<Description>OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24H 23ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43419-580-18</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43419-580-18) > 60 mL in 1 TUBE</PackageDescription>
<NDC11Code>43419-0580-18</NDC11Code>
<ProductNDC>43419-580</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amorepacific Natural Protector</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160118</StartMarketingDate>
<EndMarketingDate>20200530</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1500; 5400; 2700; 5400</StrengthNumber>
<StrengthUnit>mg/60mL; mg/60mL; mg/60mL; mg/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160118</StartMarketingDatePackage>
<EndMarketingDatePackage>20200530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59630-580-18</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (59630-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59630-0580-18</NDC11Code>
<ProductNDC>59630-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osphena</ProprietaryName>
<NonProprietaryName>Ospemifene</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130226</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203505</ApplicationNumber>
<LabelerName>Shionogi Inc.</LabelerName>
<SubstanceName>OSPEMIFENE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170415</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OSPHENA is indicated for.</IndicationAndUsage>
<Description>OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1. The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C24H23ClO2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>50458-580-07</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (50458-580-07) </PackageDescription>
<NDC11Code>50458-0580-07</NDC11Code>
<ProductNDC>50458-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xarelto</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022406</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>50458-580-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (50458-580-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (50458-580-01) </PackageDescription>
<NDC11Code>50458-0580-10</NDC11Code>
<ProductNDC>50458-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xarelto</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022406</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>50458-580-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50458-580-30) </PackageDescription>
<NDC11Code>50458-0580-30</NDC11Code>
<ProductNDC>50458-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xarelto</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022406</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>50458-580-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50458-580-90) </PackageDescription>
<NDC11Code>50458-0580-90</NDC11Code>
<ProductNDC>50458-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xarelto</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022406</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>59310-580-20</NDCCode>
<PackageDescription>1 INHALER in 1 BOX (59310-580-20) / 200 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0580-20</NDC11Code>
<ProductNDC>59310-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair Respiclick</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150423</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205636</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROAIR RESPICLICK is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2).</IndicationAndUsage>
<Description>The active ingredient of PROAIR RESPICLICK inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. PROAIR RESPICLICK is an inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, the PROAIR RESPICLICK inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 actuations (inhalations).</Description>
</NDC>
<NDC>
<NDCCode>59310-580-21</NDCCode>
<PackageDescription>1 INHALER in 1 BOX (59310-580-21) > 200 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0580-21</NDC11Code>
<ProductNDC>59310-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair Respiclick</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150423</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205636</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROAIR RESPICLICK is a beta2-adrenergic agonist indicated for: 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1), 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2).</IndicationAndUsage>
<Description>The active ingredient of PROAIR RESPICLICK inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta2-adrenergic agonist. It has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S. Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. PROAIR RESPICLICK is an inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, the PROAIR RESPICLICK inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 actuations (inhalations).</Description>
</NDC>
<NDC>
<NDCCode>68084-580-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68084-580-01) > 10 TABLET in 1 BLISTER PACK (68084-580-11)</PackageDescription>
<NDC11Code>68084-0580-01</NDC11Code>
<ProductNDC>68084-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077031</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>69654-580-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69654-580-30) </PackageDescription>
<NDC11Code>69654-0580-30</NDC11Code>
<ProductNDC>69654-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metadate Cd</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021259</ApplicationNumber>
<LabelerName>Aytu BioPharma, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>METADATE CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of METADATE CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7). Use in Specific Populations ( 8.4)] .</IndicationAndUsage>
<Description>METADATE CD contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. METADATE CD is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d, l(racemic)- threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is:. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. METADATE CD also contains the following inactive ingredients: Dibutyl sebacate, ethylcellulose aqueous dispersion, gelatin, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sugar spheres, and titanium dioxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: FD&C Blue No. 2. 30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide. 40 mg capsules: FDA/E172 Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>72189-580-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (72189-580-60) </PackageDescription>
<NDC11Code>72189-0580-60</NDC11Code>
<ProductNDC>72189-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Sublingual C-iii</ProprietaryName>
<NonProprietaryName>Buprenorphine Sublingual C-iii</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20240916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078633</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine Sublingual Tablets are supplied as white, sublingual tablets available in two dosage strengths, 2 mg buprenorphine free base and 8 mg buprenorphine free base. Each tablet also contains citric acid anhydrous, corn starch, crospovidone, lactose monohydrate, magnesium stearate, mannitol, povidone, purified water and sodium citrate. Chemically, buprenorphine hydrochloride, USP is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O-methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure. [chem-fig]. Buprenorphine hydrochloride, USP has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane, acetone, and ethylacetate.</Description>
</NDC>
<NDC>
<NDCCode>72189-580-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72189-580-90) </PackageDescription>
<NDC11Code>72189-0580-90</NDC11Code>
<ProductNDC>72189-580</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Sublingual C-iii</ProprietaryName>
<NonProprietaryName>Buprenorphine Sublingual C-iii</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20240916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078633</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine Sublingual Tablets are supplied as white, sublingual tablets available in two dosage strengths, 2 mg buprenorphine free base and 8 mg buprenorphine free base. Each tablet also contains citric acid anhydrous, corn starch, crospovidone, lactose monohydrate, magnesium stearate, mannitol, povidone, purified water and sodium citrate. Chemically, buprenorphine hydrochloride, USP is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O-methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure. [chem-fig]. Buprenorphine hydrochloride, USP has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane, acetone, and ethylacetate.</Description>
</NDC>
<NDC>
<NDCCode>55494-100-10</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) </PackageDescription>
<NDC11Code>55494-0100-10</NDC11Code>
<ProductNDC>55494-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclegis</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130515</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021876</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>55494-100-99</NDCCode>
<PackageDescription>12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) </PackageDescription>
<NDC11Code>55494-0100-99</NDC11Code>
<ProductNDC>55494-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclegis</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130515</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021876</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140328</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. DICLEGIS has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets are round, white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue#2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>55494-120-10</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10) </PackageDescription>
<NDC11Code>55494-0120-10</NDC11Code>
<ProductNDC>55494-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonjesta</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209661</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>55494-120-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60) </PackageDescription>
<NDC11Code>55494-0120-60</NDC11Code>
<ProductNDC>55494-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonjesta</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209661</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>55494-120-94</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55494-0120-94</NDC11Code>
<ProductNDC>55494-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonjesta</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209661</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250226</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>55494-120-99</NDCCode>
<PackageDescription>6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99) </PackageDescription>
<NDC11Code>55494-0120-99</NDC11Code>
<ProductNDC>55494-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bonjesta</ProprietaryName>
<NonProprietaryName>Doxylamine Succinate And Pyridoxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209661</ApplicationNumber>
<LabelerName>Duchesnay USA, Inc.</LabelerName>
<SubstanceName>DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180219</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use. BONJESTA has not been studied in women with hyperemesis gravidarum.</IndicationAndUsage>
<Description>BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. BONJESTA tablets are round, pink, film-coated, multilayer, extended-release tablets containing a total of 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. Tablets are imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. BONJESTA is certified Kosher, Kosher for Passover and Halal . Doxylamine Succinate. Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O C4H6O4 and the molecular mass is 388.46. The structural formula is. Doxylamine succinate is a white to creamy white powder that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride. Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The empirical formula is C8H11NO3 HCl and the molecular mass is 205.64. The structural formula is. Pyridoxine hydrochloride is a white or practically white crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>0143-9533-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX, UNIT-DOSE (0143-9533-01) > 25 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9533-01</NDC11Code>
<ProductNDC>0143-9533</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol Sodium</ProprietaryName>
<NonProprietaryName>Allopurinol Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076870</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ALLOPURINOL SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/25mL</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol Sodium for Injection is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.</IndicationAndUsage>
<Description>Allopurinol Sodium for Injection, a xanthine oxidase inhibitor, is a sterile, white, lyophilized powder or cake, in a single-dose vial for reconstitution. Each vial contains 500 mg of allopurinol equivalent to 580.7 mg of allopurinol sodium and 162.5 mg of sodium hydroxide as a solubilizer. Sodium hydroxide is also used as a pH adjuster. Allopurinol Sodium for Injection contains no preservatives. Allopurinol is a xanthine oxidase inhibitor. The chemical name for allopurinol sodium is 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C5H3N4NaO. The structural formula is. The pKa of allopurinol sodium is 9.31.</Description>
</NDC>
<NDC>
<NDCCode>0173-0922-38</NDCCode>
<PackageDescription>8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) </PackageDescription>
<NDC11Code>00173-0922-38</NDC11Code>
<ProductNDC>0173-0922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Blujepa</ProprietaryName>
<NonProprietaryName>Gepotidacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250325</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218230</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>GEPOTIDACIN MESYLATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).</IndicationAndUsage>
<Description>BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0173-0922-45</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) </PackageDescription>
<NDC11Code>00173-0922-45</NDC11Code>
<ProductNDC>0173-0922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Blujepa</ProprietaryName>
<NonProprietaryName>Gepotidacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250325</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218230</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>GEPOTIDACIN MESYLATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: 1 Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). (1.1), 2 Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. (1.2, 6.1).</IndicationAndUsage>
<Description>BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (R)-2-((4-(((3,4-dihydro-2H-pyrano[2,3-c]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C24H28N6O3●CH4O3S●2H2O and its molecular mass is 580.66. The structural formula is shown below. *stereogenic center. Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-03</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-0644-03) </PackageDescription>
<NDC11Code>00338-0644-03</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-0644-04) </PackageDescription>
<NDC11Code>00338-0644-04</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-06</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-0644-06) </PackageDescription>
<NDC11Code>00338-0644-06</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-4210-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0338-4210-02) * 1 mL in 1 VIAL, GLASS (0338-7112-01) * 1 mL in 1 VIAL, GLASS (0338-7332-01) * 1 mL in 1 VIAL, GLASS (0338-7201-01) * 1 mL in 1 VIAL, GLASS (0338-7401-01) </PackageDescription>
<NDC11Code>00338-4210-02</NDC11Code>
<ProductNDC>0338-4210</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Tisseel</ProprietaryName>
<ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
<NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19980501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103980</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
<Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1 The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2 Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3 Thrombin Solution, 4 Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5 * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
</NDC>
<NDC>
<NDCCode>0338-4211-04</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0338-4211-04) * 2 mL in 1 VIAL, GLASS (0338-7112-02) * 2 mL in 1 VIAL, GLASS (0338-7332-02) * 2 mL in 1 VIAL, GLASS (0338-7201-02) * 2 mL in 1 VIAL, GLASS (0338-7401-02) </PackageDescription>
<NDC11Code>00338-4211-04</NDC11Code>
<ProductNDC>0338-4211</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Tisseel</ProprietaryName>
<ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
<NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19980501</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103980</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.</IndicationAndUsage>
<Description>TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade. Sealer Protein (Human)Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin (Synthetic) solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) Solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human)Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. : 1 The reconstituted solution or pre-filled syringe contains: Sealer Protein Solution, 2 Total protein: 96 – 125 mg/mL Fibrinogen: 67 – 106 mg/mLAprotinin (Synthetic): 2250 – 3750 KIU/mLOther ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection., 3 Thrombin Solution, 4 Thrombin (Human): 400 – 625 units/mL* Calcium Chloride: 36 – 44 µmol/mLOther ingredients include: human albumin, sodium chloride and water for injection., 5 * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).</Description>
</NDC>
</NDCList>