{
"NDC": [
{
"NDCCode": "70661-004-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-004-30) ",
"NDC11Code": "70661-0004-30",
"ProductNDC": "70661-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 41.7",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "N",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-004-35",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70661-004-35) ",
"NDC11Code": "70661-0004-35",
"ProductNDC": "70661-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 41.7",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231231",
"SamplePackage": "N",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-004-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (70661-004-10) ",
"NDC11Code": "70661-0004-10",
"ProductNDC": "70661-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 41.7",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210915",
"SamplePackage": "Y",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-001-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-001-30) ",
"NDC11Code": "70661-0001-30",
"ProductNDC": "70661-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "Rosuvastatin And Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 5.2",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "N",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-002-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-002-30) ",
"NDC11Code": "70661-0002-30",
"ProductNDC": "70661-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 10.4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "N",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-002-35",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70661-002-35) ",
"NDC11Code": "70661-0002-35",
"ProductNDC": "70661-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 10.4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231231",
"SamplePackage": "N",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-002-39",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-002-39) ",
"NDC11Code": "70661-0002-39",
"ProductNDC": "70661-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 10.4",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "Y",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-003-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-003-30) ",
"NDC11Code": "70661-0003-30",
"ProductNDC": "70661-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 20.8",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "N",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-003-35",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (70661-003-35) ",
"NDC11Code": "70661-0003-35",
"ProductNDC": "70661-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 20.8",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231231",
"SamplePackage": "N",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-003-39",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-003-39) ",
"NDC11Code": "70661-0003-39",
"ProductNDC": "70661-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roszet",
"NonProprietaryName": "(rosuvastatin And Ezetimibe)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213072",
"LabelerName": "Althera Pharmaceuticals LLC",
"SubstanceName": "EZETIMIBE; ROSUVASTATIN CALCIUM",
"StrengthNumber": "10; 20.8",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210510",
"SamplePackage": "Y",
"IndicationAndUsage": "ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.",
"Description": "ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide."
},
{
"NDCCode": "70661-005-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-005-30) ",
"NDC11Code": "70661-0005-30",
"ProductNDC": "70661-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lypqozet",
"NonProprietaryName": "(ezetimibe And Atorvastatin)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206084",
"LabelerName": "Althera Pharmaceuticals, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE",
"StrengthNumber": "10.34; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "LYPQOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Atorvastatin calcium, USP is a white to off-white amorphous powder that is very slightly soluble in water, insoluble in acetonitrile, and soluble in methanol. The molecular formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca. The molecular weight of atorvastatin calcium is 1155.37. Its structural formula is. LYPQOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.34 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LYPQOZET 10 mg/10 mg); 20.68 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LYPQOZET 10 mg/20 mg); 41.37 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LYPQOZET 10 mg/40 mg); or 82.73 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LYPQOZET 10 mg/80 mg). Each film-coated tablet of LYPQOZET contain the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, polysorbate 80, red 30 iron oxide, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "70661-006-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-006-30) ",
"NDC11Code": "70661-0006-30",
"ProductNDC": "70661-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lypqozet",
"NonProprietaryName": "(ezetimibe And Atorvastatin)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206084",
"LabelerName": "Althera Pharmaceuticals, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE",
"StrengthNumber": "20.68; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "LYPQOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Atorvastatin calcium, USP is a white to off-white amorphous powder that is very slightly soluble in water, insoluble in acetonitrile, and soluble in methanol. The molecular formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca. The molecular weight of atorvastatin calcium is 1155.37. Its structural formula is. LYPQOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.34 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LYPQOZET 10 mg/10 mg); 20.68 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LYPQOZET 10 mg/20 mg); 41.37 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LYPQOZET 10 mg/40 mg); or 82.73 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LYPQOZET 10 mg/80 mg). Each film-coated tablet of LYPQOZET contain the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, polysorbate 80, red 30 iron oxide, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "70661-007-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-007-30) ",
"NDC11Code": "70661-0007-30",
"ProductNDC": "70661-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lypqozet",
"NonProprietaryName": "(ezetimibe And Atorvastatin)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206084",
"LabelerName": "Althera Pharmaceuticals, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE",
"StrengthNumber": "41.37; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "LYPQOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Atorvastatin calcium, USP is a white to off-white amorphous powder that is very slightly soluble in water, insoluble in acetonitrile, and soluble in methanol. The molecular formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca. The molecular weight of atorvastatin calcium is 1155.37. Its structural formula is. LYPQOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.34 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LYPQOZET 10 mg/10 mg); 20.68 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LYPQOZET 10 mg/20 mg); 41.37 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LYPQOZET 10 mg/40 mg); or 82.73 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LYPQOZET 10 mg/80 mg). Each film-coated tablet of LYPQOZET contain the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, polysorbate 80, red 30 iron oxide, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "70661-008-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (70661-008-30) ",
"NDC11Code": "70661-0008-30",
"ProductNDC": "70661-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lypqozet",
"NonProprietaryName": "(ezetimibe And Atorvastatin)",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206084",
"LabelerName": "Althera Pharmaceuticals, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE",
"StrengthNumber": "82.73; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "LYPQOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Atorvastatin calcium, USP is a white to off-white amorphous powder that is very slightly soluble in water, insoluble in acetonitrile, and soluble in methanol. The molecular formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca. The molecular weight of atorvastatin calcium is 1155.37. Its structural formula is. LYPQOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.34 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LYPQOZET 10 mg/10 mg); 20.68 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LYPQOZET 10 mg/20 mg); 41.37 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LYPQOZET 10 mg/40 mg); or 82.73 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LYPQOZET 10 mg/80 mg). Each film-coated tablet of LYPQOZET contain the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, polysorbate 80, red 30 iron oxide, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "10095-004-01",
"PackageDescription": "30 g in 1 PACKAGE (10095-004-01)",
"NDC11Code": "10095-0004-01",
"ProductNDC": "10095-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurochrome",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150505",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "World Perfumes, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Mercurochrome. Mercury Free. First Aid Antiseptic. For External Use Only."
},
{
"NDCCode": "10348-004-01",
"PackageDescription": "1 TUBE in 1 CARTON (10348-004-01) > 30 mL in 1 TUBE",
"NDC11Code": "10348-0004-01",
"ProductNDC": "10348-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smashbox",
"ProprietaryNameSuffix": "Photo Finish Spf 15 Foundation Primer",
"NonProprietaryName": "Octinoxate And Octisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "7.5; 5",
"StrengthUnit": "mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10544-004-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (10544-004-30)",
"NDC11Code": "10544-0004-30",
"ProductNDC": "10544-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065253",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin capsules are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalisSkin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenesBone infections caused by Staphylococcus aureus and/or Proteus mirabilisGenitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniaeNote — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cephalexin capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4S H 2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate."
},
{
"NDCCode": "11054-004-30",
"PackageDescription": "3120 L in 1 CYLINDER (11054-004-30) ",
"NDC11Code": "11054-0004-30",
"ProductNDC": "11054-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium",
"NonProprietaryName": "Helium",
"DosageFormName": "GAS",
"RouteName": "INTRACORONARY; RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971106",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205843",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "HELIUM",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971106",
"SamplePackage": "N"
},
{
"NDCCode": "13551-004-30",
"PackageDescription": "30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET",
"NDC11Code": "13551-0004-30",
"ProductNDC": "13551-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumryz",
"NonProprietaryName": "Sodium Oxybate",
"DosageFormName": "FOR SUSPENSION, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214755",
"LabelerName": "Alkermes, Inc.",
"SubstanceName": "SODIUM OXYBATE",
"StrengthNumber": "9",
"StrengthUnit": "g/1",
"Pharm_Classes": "Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.",
"Description": "Sodium oxybate, a CNS depressant, is the active ingredient in LUMRYZ for extended-release oral suspension. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is. Sodium oxybate is a white to off-white solid powder. Each packet of LUMRYZ contains 4.5 g, 6 g, 7.5 g, or 9 g of sodium oxybate, equivalent to 3.7 g, 5.0 g, 6.2 g, or 7.4 g of oxybate, respectively. The inactive ingredients are carrageenan, hydrogenated vegetable oil, hydroxyethyl cellulose, magnesium stearate, malic acid, methacrylic acid copolymer, microcrystalline cellulose, povidone, and xanthan gum."
},
{
"NDCCode": "13668-004-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (13668-004-30) ",
"NDC11Code": "13668-0004-30",
"ProductNDC": "13668-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077765",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140925",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "13913-004-13",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (13913-004-13)",
"NDC11Code": "13913-0004-13",
"ProductNDC": "13913-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gralise",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110128",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022544",
"LabelerName": "Depomed, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "14783-004-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-004-02) > 30 g in 1 TUBE (14783-004-01)",
"NDC11Code": "14783-0004-02",
"ProductNDC": "14783-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16",
"ProprietaryNameSuffix": "Medium 5 - Beige",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16729-004-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-004-10) ",
"NDC11Code": "16729-0004-10",
"ProductNDC": "16729-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080226",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablet is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate."
},
{
"NDCCode": "16995-004-04",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (16995-004-04)",
"NDC11Code": "16995-0004-04",
"ProductNDC": "16995-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Floril Tears",
"NonProprietaryName": "Polyvinyl Alcohol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20051110",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "VITALINE S.A.C.",
"SubstanceName": "POLYVINYL ALCOHOL",
"StrengthNumber": "14",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporary relief of eye dryness and redness due to insufficient production of tears. prevents further irritation."
},
{
"NDCCode": "20482-004-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (20482-004-30) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY",
"NDC11Code": "20482-0004-30",
"ProductNDC": "20482-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Subsys",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "SPRAY",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120313",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202788",
"LabelerName": "Insys Therapeutics, Inc.",
"SubstanceName": "FENTANYL",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120313",
"SamplePackage": "N",
"IndicationAndUsage": "SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room [see Contraindications ( 4)]. , 3 As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS ACCESS Program, SUBSYS may be dispensed only to outpatients enrolled in the program. [see Warnings and Precautions ( 5.7)] . For inpatient administration of SUBSYS, patient enrollment is not required. .",
"Description": "SUBSYS (fentanyl sublingual spray) is an opioid agonist, available as a sublingual spray designed to deliver doses of 100, 200, 400, 600, 800, 1200 and 1600 mcg of fentanyl. The chemical name of fentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide. Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 860:1) that is freely soluble in ethanol and methanol and practically insoluble in water (1:40). The molecular weight of the free base is 336.47. The pKa is 8.4. The inactive ingredients in SUBSYS include: dehydrated alcohol 63.6% (V/V), purified water, propylene glycol, xylitol, and L-menthol."
},
{
"NDCCode": "24236-004-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (24236-004-02)",
"NDC11Code": "24236-0004-02",
"ProductNDC": "24236-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040218",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "24562-004-30",
"PackageDescription": "30 mL in 1 VIAL, GLASS (24562-004-30) ",
"NDC11Code": "24562-0004-30",
"ProductNDC": "24562-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ammonia N 13",
"NonProprietaryName": "Ammonia N-13",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204352",
"LabelerName": "Biomedical Research Foundation of Northwest Louisiana",
"SubstanceName": "AMMONIA N-13",
"StrengthNumber": "37.5",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150514",
"SamplePackage": "N",
"IndicationAndUsage": "Ammonia N 13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.",
"Description": "Ammonia N 13 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [13N] ammonia, has the molecular formula of 13NH3with a molecular weight of 16.02, and has the following chemical structure. Ammonia N 13 Injection, USP is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride solution. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of ammonia."
},
{
"NDCCode": "24979-004-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (24979-004-06) ",
"NDC11Code": "24979-0004-06",
"ProductNDC": "24979-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203104",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150301",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride tablets USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients in 23 mg tablets include hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, sodium hydroxide, triethyl citrate, iron oxide black, and propylene glycol. USP Dissolution Test pending. USP Organic Impurities Test pending."
},
{
"NDCCode": "27281-004-96",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (27281-004-96)",
"NDC11Code": "27281-0004-96",
"ProductNDC": "27281-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Immune Booster",
"NonProprietaryName": "Apis Mellifera, Baptisia Tinctoria, Silybum Marianum Seed, Herring Sperm Dna, Echinacea, Galium Aparine, Mercuric Chloride, Mercuric Sulfide, Nitric Acid, Sulfur Iodide, And Thuja Occidentalis Leafy Twig",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sunway Biotech LLC",
"SubstanceName": "APIS MELLIFERA; BAPTISIA TINCTORIA; SILYBUM MARIANUM SEED OIL; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "200; 3; 1.5; 3; 3; 1.5; 200; 30; 30; 200; 200",
"StrengthUnit": "[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Helps support the body's natural defense mechanisms and temporarily relieves: tendencies toward flu & cold; joint pain; minor allergies; low endocrine function."
},
{
"NDCCode": "29033-004-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-004-30) ",
"NDC11Code": "29033-0004-30",
"ProductNDC": "29033-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076697",
"LabelerName": "Nostrum Laboratories, Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110520",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70661-004-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-004-30) </PackageDescription>
<NDC11Code>70661-0004-30</NDC11Code>
<ProductNDC>70661-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 41.7</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-004-35</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70661-004-35) </PackageDescription>
<NDC11Code>70661-0004-35</NDC11Code>
<ProductNDC>70661-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 41.7</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-004-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (70661-004-10) </PackageDescription>
<NDC11Code>70661-0004-10</NDC11Code>
<ProductNDC>70661-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 41.7</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210915</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-001-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-001-30) </PackageDescription>
<NDC11Code>70661-0001-30</NDC11Code>
<ProductNDC>70661-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>Rosuvastatin And Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 5.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-002-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-002-30) </PackageDescription>
<NDC11Code>70661-0002-30</NDC11Code>
<ProductNDC>70661-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 10.4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-002-35</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70661-002-35) </PackageDescription>
<NDC11Code>70661-0002-35</NDC11Code>
<ProductNDC>70661-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 10.4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-002-39</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-002-39) </PackageDescription>
<NDC11Code>70661-0002-39</NDC11Code>
<ProductNDC>70661-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 10.4</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-003-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-003-30) </PackageDescription>
<NDC11Code>70661-0003-30</NDC11Code>
<ProductNDC>70661-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 20.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-003-35</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (70661-003-35) </PackageDescription>
<NDC11Code>70661-0003-35</NDC11Code>
<ProductNDC>70661-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 20.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-003-39</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-003-39) </PackageDescription>
<NDC11Code>70661-0003-39</NDC11Code>
<ProductNDC>70661-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roszet</ProprietaryName>
<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
<SubstanceName>EZETIMIBE; ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10; 20.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210510</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ROSZET is indicated in adults: 1 As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)., 2 Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.</IndicationAndUsage>
<Description>ROSZET tablets contain rosuvastatin calcium and ezetimibe. Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.43 g.mol-1. Ezetimibe is a white, crystalline powder, which is insoluble in water. Its structural formula is. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methyl sulfonyl)amino] pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt to [S-[R*,S*-(E)]]-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid, calcium salt (2:1). The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14 g.mol-1. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Its structural formula is. ROSZET tablets 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg, and 40 mg/10 mg contain the equivalent of 5, 10, 20, and 40 mg rosuvastatin (provided as rosuvastatin calcium 5.2, 10.4, 20.8, and 41.7 mg) and 10 mg ezetimibe. Each film-coated tablet of ROSZET contains the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, meglumine, dibasic calcium phosphate dihydrate, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, mannitol, sodium lauryl sulfate, croscarmellose sodium, povidone, ferric oxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-005-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-005-30) </PackageDescription>
<NDC11Code>70661-0005-30</NDC11Code>
<ProductNDC>70661-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lypqozet</ProprietaryName>
<NonProprietaryName>(ezetimibe And Atorvastatin)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206084</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE</SubstanceName>
<StrengthNumber>10.34; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>LYPQOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Atorvastatin calcium, USP is a white to off-white amorphous powder that is very slightly soluble in water, insoluble in acetonitrile, and soluble in methanol. The molecular formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca. The molecular weight of atorvastatin calcium is 1155.37. Its structural formula is. LYPQOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.34 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LYPQOZET 10 mg/10 mg); 20.68 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LYPQOZET 10 mg/20 mg); 41.37 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LYPQOZET 10 mg/40 mg); or 82.73 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LYPQOZET 10 mg/80 mg). Each film-coated tablet of LYPQOZET contain the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, polysorbate 80, red 30 iron oxide, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-006-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-006-30) </PackageDescription>
<NDC11Code>70661-0006-30</NDC11Code>
<ProductNDC>70661-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lypqozet</ProprietaryName>
<NonProprietaryName>(ezetimibe And Atorvastatin)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206084</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE</SubstanceName>
<StrengthNumber>20.68; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>LYPQOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Atorvastatin calcium, USP is a white to off-white amorphous powder that is very slightly soluble in water, insoluble in acetonitrile, and soluble in methanol. The molecular formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca. The molecular weight of atorvastatin calcium is 1155.37. Its structural formula is. LYPQOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.34 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LYPQOZET 10 mg/10 mg); 20.68 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LYPQOZET 10 mg/20 mg); 41.37 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LYPQOZET 10 mg/40 mg); or 82.73 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LYPQOZET 10 mg/80 mg). Each film-coated tablet of LYPQOZET contain the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, polysorbate 80, red 30 iron oxide, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-007-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-007-30) </PackageDescription>
<NDC11Code>70661-0007-30</NDC11Code>
<ProductNDC>70661-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lypqozet</ProprietaryName>
<NonProprietaryName>(ezetimibe And Atorvastatin)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206084</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE</SubstanceName>
<StrengthNumber>41.37; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>LYPQOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Atorvastatin calcium, USP is a white to off-white amorphous powder that is very slightly soluble in water, insoluble in acetonitrile, and soluble in methanol. The molecular formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca. The molecular weight of atorvastatin calcium is 1155.37. Its structural formula is. LYPQOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.34 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LYPQOZET 10 mg/10 mg); 20.68 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LYPQOZET 10 mg/20 mg); 41.37 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LYPQOZET 10 mg/40 mg); or 82.73 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LYPQOZET 10 mg/80 mg). Each film-coated tablet of LYPQOZET contain the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, polysorbate 80, red 30 iron oxide, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70661-008-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70661-008-30) </PackageDescription>
<NDC11Code>70661-0008-30</NDC11Code>
<ProductNDC>70661-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lypqozet</ProprietaryName>
<NonProprietaryName>(ezetimibe And Atorvastatin)</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206084</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE</SubstanceName>
<StrengthNumber>82.73; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>LYPQOZET contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Atorvastatin is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). Atorvastatin calcium, USP is a white to off-white amorphous powder that is very slightly soluble in water, insoluble in acetonitrile, and soluble in methanol. The molecular formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca. The molecular weight of atorvastatin calcium is 1155.37. Its structural formula is. LYPQOZET is available for oral use as tablets containing 10 mg of ezetimibe and: 10.34 mg of atorvastatin calcium, equivalent to 10 mg of atorvastatin (LYPQOZET 10 mg/10 mg); 20.68 mg of atorvastatin calcium, equivalent to 20 mg of atorvastatin (LYPQOZET 10 mg/20 mg); 41.37 mg of atorvastatin calcium, equivalent to 40 mg of atorvastatin (LYPQOZET 10 mg/40 mg); or 82.73 mg of atorvastatin calcium, equivalent to 80 mg of atorvastatin (LYPQOZET 10 mg/80 mg). Each film-coated tablet of LYPQOZET contain the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, polysorbate 80, red 30 iron oxide, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>10095-004-01</NDCCode>
<PackageDescription>30 g in 1 PACKAGE (10095-004-01)</PackageDescription>
<NDC11Code>10095-0004-01</NDC11Code>
<ProductNDC>10095-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurochrome</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>World Perfumes, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Mercurochrome. Mercury Free. First Aid Antiseptic. For External Use Only.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10348-004-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10348-004-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>10348-0004-01</NDC11Code>
<ProductNDC>10348-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smashbox</ProprietaryName>
<ProprietaryNameSuffix>Photo Finish Spf 15 Foundation Primer</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>7.5; 5</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10544-004-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (10544-004-30)</PackageDescription>
<NDC11Code>10544-0004-30</NDC11Code>
<ProductNDC>10544-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065253</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin capsules are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalisSkin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenesBone infections caused by Staphylococcus aureus and/or Proteus mirabilisGenitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniaeNote — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cephalexin capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16H 17N 3O 4S H 2O and the molecular weight is 365.41. Cephalexin has the following structural formula:. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin, magnesium stearate, titanium dioxide, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>11054-004-30</NDCCode>
<PackageDescription>3120 L in 1 CYLINDER (11054-004-30) </PackageDescription>
<NDC11Code>11054-0004-30</NDC11Code>
<ProductNDC>11054-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>INTRACORONARY; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205843</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13551-004-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET</PackageDescription>
<NDC11Code>13551-0004-30</NDC11Code>
<ProductNDC>13551-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumryz</ProprietaryName>
<NonProprietaryName>Sodium Oxybate</NonProprietaryName>
<DosageFormName>FOR SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214755</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>SODIUM OXYBATE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.</IndicationAndUsage>
<Description>Sodium oxybate, a CNS depressant, is the active ingredient in LUMRYZ for extended-release oral suspension. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is. Sodium oxybate is a white to off-white solid powder. Each packet of LUMRYZ contains 4.5 g, 6 g, 7.5 g, or 9 g of sodium oxybate, equivalent to 3.7 g, 5.0 g, 6.2 g, or 7.4 g of oxybate, respectively. The inactive ingredients are carrageenan, hydrogenated vegetable oil, hydroxyethyl cellulose, magnesium stearate, malic acid, methacrylic acid copolymer, microcrystalline cellulose, povidone, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>13668-004-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (13668-004-30) </PackageDescription>
<NDC11Code>13668-0004-30</NDC11Code>
<ProductNDC>13668-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077765</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140925</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13913-004-13</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (13913-004-13)</PackageDescription>
<NDC11Code>13913-0004-13</NDC11Code>
<ProductNDC>13913-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gralise</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110128</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022544</ApplicationNumber>
<LabelerName>Depomed, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>14783-004-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-004-02) > 30 g in 1 TUBE (14783-004-01)</PackageDescription>
<NDC11Code>14783-0004-02</NDC11Code>
<ProductNDC>14783-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Mineral Natural Skin Effect Mousse Foundation Spf 16</ProprietaryName>
<ProprietaryNameSuffix>Medium 5 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .024; .015</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16729-004-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-004-10) </PackageDescription>
<NDC11Code>16729-0004-10</NDC11Code>
<ProductNDC>16729-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078155</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablet is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>16995-004-04</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (16995-004-04)</PackageDescription>
<NDC11Code>16995-0004-04</NDC11Code>
<ProductNDC>16995-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Floril Tears</ProprietaryName>
<NonProprietaryName>Polyvinyl Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20051110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>VITALINE S.A.C.</LabelerName>
<SubstanceName>POLYVINYL ALCOHOL</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporary relief of eye dryness and redness due to insufficient production of tears. prevents further irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>20482-004-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (20482-004-30) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>20482-0004-30</NDC11Code>
<ProductNDC>20482-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Subsys</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120313</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202788</ApplicationNumber>
<LabelerName>Insys Therapeutics, Inc.</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room [see Contraindications ( 4)]. , 3 As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS ACCESS Program, SUBSYS may be dispensed only to outpatients enrolled in the program. [see Warnings and Precautions ( 5.7)] . For inpatient administration of SUBSYS, patient enrollment is not required. .</IndicationAndUsage>
<Description>SUBSYS (fentanyl sublingual spray) is an opioid agonist, available as a sublingual spray designed to deliver doses of 100, 200, 400, 600, 800, 1200 and 1600 mcg of fentanyl. The chemical name of fentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide. Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 860:1) that is freely soluble in ethanol and methanol and practically insoluble in water (1:40). The molecular weight of the free base is 336.47. The pKa is 8.4. The inactive ingredients in SUBSYS include: dehydrated alcohol 63.6% (V/V), purified water, propylene glycol, xylitol, and L-menthol.</Description>
</NDC>
<NDC>
<NDCCode>24236-004-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (24236-004-02)</PackageDescription>
<NDC11Code>24236-0004-02</NDC11Code>
<ProductNDC>24236-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040218</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>24562-004-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (24562-004-30) </PackageDescription>
<NDC11Code>24562-0004-30</NDC11Code>
<ProductNDC>24562-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ammonia N 13</ProprietaryName>
<NonProprietaryName>Ammonia N-13</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204352</ApplicationNumber>
<LabelerName>Biomedical Research Foundation of Northwest Louisiana</LabelerName>
<SubstanceName>AMMONIA N-13</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ammonia N 13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.</IndicationAndUsage>
<Description>Ammonia N 13 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [13N] ammonia, has the molecular formula of 13NH3with a molecular weight of 16.02, and has the following chemical structure. Ammonia N 13 Injection, USP is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride solution. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of ammonia.</Description>
</NDC>
<NDC>
<NDCCode>24979-004-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (24979-004-06) </PackageDescription>
<NDC11Code>24979-0004-06</NDC11Code>
<ProductNDC>24979-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203104</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>23</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride tablets USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients in 23 mg tablets include hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, sodium hydroxide, triethyl citrate, iron oxide black, and propylene glycol. USP Dissolution Test pending. USP Organic Impurities Test pending.</Description>
</NDC>
<NDC>
<NDCCode>27281-004-96</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (27281-004-96)</PackageDescription>
<NDC11Code>27281-0004-96</NDC11Code>
<ProductNDC>27281-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Immune Booster</ProprietaryName>
<NonProprietaryName>Apis Mellifera, Baptisia Tinctoria, Silybum Marianum Seed, Herring Sperm Dna, Echinacea, Galium Aparine, Mercuric Chloride, Mercuric Sulfide, Nitric Acid, Sulfur Iodide, And Thuja Occidentalis Leafy Twig</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sunway Biotech LLC</LabelerName>
<SubstanceName>APIS MELLIFERA; BAPTISIA TINCTORIA; SILYBUM MARIANUM SEED OIL; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>200; 3; 1.5; 3; 3; 1.5; 200; 30; 30; 200; 200</StrengthNumber>
<StrengthUnit>[hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Helps support the body's natural defense mechanisms and temporarily relieves: tendencies toward flu & cold; joint pain; minor allergies; low endocrine function.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>29033-004-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-004-30) </PackageDescription>
<NDC11Code>29033-0004-30</NDC11Code>
<ProductNDC>29033-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076697</ApplicationNumber>
<LabelerName>Nostrum Laboratories, Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>