{
"NDC": [
{
"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": "70661-002-39",
"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": "70661-003-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (70661-003-10) ",
"NDC11Code": "70661-0003-10",
"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": "20210615",
"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": "70072-003-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (70072-003-02) > 479.39 g in 1 CONTAINER (70072-003-01)",
"NDC11Code": "70072-0003-02",
"ProductNDC": "70072-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Elf Perm",
"NonProprietaryName": "Panthenol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150905",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "giod Co.",
"SubstanceName": "PANTHENOL",
"StrengthNumber": ".47",
"StrengthUnit": "g/479.39g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Shampoo and remove excessive moisture from hair with a towelApply the first solution and roll hair in curlersAllow 10 minutes of heat treatment (Adjust ±5-10 minutes depends on the time needed)Apply second solution and rinse."
},
{
"NDCCode": "71712-003-39",
"PackageDescription": "25000 mL in 1 BOTTLE (71712-003-39) ",
"NDC11Code": "71712-0003-39",
"ProductNDC": "71712-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sani Pure Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200326",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wuxi Huoban Daily-Use Chemicals Science and Technology Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200326",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin. recommended for repeated use."
},
{
"NDCCode": "73905-003-39",
"PackageDescription": "45000 mL in 1 BOTTLE (73905-003-39) ",
"NDC11Code": "73905-0003-39",
"ProductNDC": "73905-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200328",
"EndMarketingDate": "20240423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200328",
"EndMarketingDatePackage": "20240423",
"SamplePackage": "N"
},
{
"NDCCode": "74168-003-39",
"PackageDescription": "3000 mL in 1 BOTTLE, PUMP (74168-003-39) ",
"NDC11Code": "74168-0003-39",
"ProductNDC": "74168-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Gel",
"ProprietaryNameSuffix": "75% Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200408",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Yasili Cosmetics Co. Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200408",
"SamplePackage": "N"
},
{
"NDCCode": "75402-003-06",
"PackageDescription": "39.97 mL in 1 BOTTLE, PLASTIC (75402-003-06) ",
"NDC11Code": "75402-0003-06",
"ProductNDC": "75402-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Poet Gel Hand Sanitizer",
"NonProprietaryName": "Gel Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "POET Research Center, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N"
},
{
"NDCCode": "80982-003-39",
"PackageDescription": "240 g in 1 TUBE (80982-003-39) ",
"NDC11Code": "80982-0003-39",
"ProductNDC": "80982-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zinc Five-o",
"ProprietaryNameSuffix": "Spf-50",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201120",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ASTIVITA LIMITED",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "25",
"StrengthUnit": "g/240g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "24488-003-40",
"PackageDescription": "85.2 g in 1 CONTAINER (24488-003-40)",
"NDC11Code": "24488-0003-40",
"ProductNDC": "24488-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boy Butter",
"ProprietaryNameSuffix": "Desensitizing Lubricant",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110523",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Boy Butter Lubes",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "6.39",
"StrengthUnit": "g/85.2g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps in the prevention of premature ejaculation. For temporary male genital desensitization, helping to slow the onset of ejaculation. Helps in temporarily slowing the onset of ejaculation. For reducing oversensitivity in the male in advance of intercourse."
},
{
"NDCCode": "41433-003-02",
"PackageDescription": "2 BOTTLE in 1 BOX (41433-003-02) / 5 mL in 1 BOTTLE",
"NDC11Code": "41433-0003-02",
"ProductNDC": "41433-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Siang Pureoil Formula Ii 5ml",
"NonProprietaryName": "Menthol, Peppermint, Camphor, Clove, Cinnamon Oil",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260519",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "BERTRAM (1958) COMPANY LIMITED",
"SubstanceName": "MENTHOL; PEPPERMINT; CAMPHOR (NATURAL); CLOVE; CINNAMON OIL",
"StrengthNumber": "39.5; 34.5; 8; .3; .2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260521",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieve body aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
},
{
"NDCCode": "73362-003-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (73362-003-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-003-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE",
"NDC11Code": "73362-0003-01",
"ProductNDC": "73362-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skytrofa",
"NonProprietaryName": "Lonapegsomatropin-tcgd",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761177",
"LabelerName": "Ascendis Pharma Endocrinology, Inc.",
"SubstanceName": "LONAPEGSOMATROPIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210825",
"SamplePackage": "N",
"IndicationAndUsage": "SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).",
"Description": "Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0."
},
{
"NDCCode": "84712-014-01",
"PackageDescription": "15 g in 1 BOTTLE (84712-014-01) ",
"NDC11Code": "84712-0014-01",
"ProductNDC": "84712-014",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Youbuy Teeth Whitening Powder",
"NonProprietaryName": "Teeth Whitening Powder",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20240913",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Guangdong Youbaijia Cosmetic Industry Co., Ltd",
"SubstanceName": "ETHYLHEXYLGLYCERIN; SODIUM LAURYL SULFATE",
"StrengthNumber": ".003; .39",
"StrengthUnit": "g/15g; g/15g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240913",
"SamplePackage": "N",
"IndicationAndUsage": "Contains whitening ingredients to help remove smoke stains, tea stains, coffee stains, and tartar attached to the surface of teeth,revitalizing the teeth with a bright and white color. The combination of probiotics and refreshing menthol brings a clear and comfortable feeling, while double caring for teeth, balancing the oral environment,maintaining oral health, making teeth bright and white, refreshing breath, and blooming confident smiles."
},
{
"NDCCode": "85631-003-01",
"PackageDescription": "60 CAPSULE in 1 BOX (85631-003-01) / 1.3 g in 1 CAPSULE",
"NDC11Code": "85631-0003-01",
"ProductNDC": "85631-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gout Relief 3310-s",
"NonProprietaryName": "Celery Seed, Medicago Sativa Whole,chicory Root",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250728",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Bispit Canada Ltd.",
"SubstanceName": "GLUCOSAMINE HYDROCHLORIDE; MORUS ALBA LEAF; LICORICE; PUERARIN; BUCKWHEAT; SODIUM CHLORIDE; MEDICAGO SATIVA WHOLE; TEA LEAF; CELERY SEED; CHICORY ROOT",
"StrengthNumber": "130; 39; 2.6; 65; 91; 26; 260; 65; 260; 234",
"StrengthUnit": "mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250728",
"SamplePackage": "N",
"IndicationAndUsage": "Dissolved CrystallizationKidney StoneGallstone< Urinary Calculus."
},
{
"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": "70661-002-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (70661-002-10) ",
"NDC11Code": "70661-0002-10",
"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": "20210615",
"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": "70661-002-30",
"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": "70661-004-10",
"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": "70661-004-30",
"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": "70661-005-30",
"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": "70661-005-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (70661-005-90) ",
"NDC11Code": "70661-0005-90",
"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": "70661-006-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (70661-006-90) ",
"NDC11Code": "70661-0006-90",
"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": "70661-007-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (70661-007-90) ",
"NDC11Code": "70661-0007-90",
"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."
}
]
}
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<ProductNDC>70661-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213072</ApplicationNumber>
<LabelerName>Althera Pharmaceuticals LLC</LabelerName>
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<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>
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<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>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>(rosuvastatin And Ezetimibe)</NonProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<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>
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<NDC>
<NDCCode>70661-003-10</NDCCode>
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<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>20210615</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>
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<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>
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<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>
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<PackageDescription>1 CONTAINER in 1 CARTON (70072-003-02) > 479.39 g in 1 CONTAINER (70072-003-01)</PackageDescription>
<NDC11Code>70072-0003-02</NDC11Code>
<ProductNDC>70072-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Elf Perm</ProprietaryName>
<NonProprietaryName>Panthenol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150905</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>giod Co.</LabelerName>
<SubstanceName>PANTHENOL</SubstanceName>
<StrengthNumber>.47</StrengthNumber>
<StrengthUnit>g/479.39g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Shampoo and remove excessive moisture from hair with a towelApply the first solution and roll hair in curlersAllow 10 minutes of heat treatment (Adjust ±5-10 minutes depends on the time needed)Apply second solution and rinse.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71712-003-39</NDCCode>
<PackageDescription>25000 mL in 1 BOTTLE (71712-003-39) </PackageDescription>
<NDC11Code>71712-0003-39</NDC11Code>
<ProductNDC>71712-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sani Pure Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Wuxi Huoban Daily-Use Chemicals Science and Technology Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73905-003-39</NDCCode>
<PackageDescription>45000 mL in 1 BOTTLE (73905-003-39) </PackageDescription>
<NDC11Code>73905-0003-39</NDC11Code>
<ProductNDC>73905-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200328</StartMarketingDate>
<EndMarketingDate>20240423</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200328</StartMarketingDatePackage>
<EndMarketingDatePackage>20240423</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74168-003-39</NDCCode>
<PackageDescription>3000 mL in 1 BOTTLE, PUMP (74168-003-39) </PackageDescription>
<NDC11Code>74168-0003-39</NDC11Code>
<ProductNDC>74168-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Gel</ProprietaryName>
<ProprietaryNameSuffix>75% Alcohol</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200408</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Yasili Cosmetics Co. Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75402-003-06</NDCCode>
<PackageDescription>39.97 mL in 1 BOTTLE, PLASTIC (75402-003-06) </PackageDescription>
<NDC11Code>75402-0003-06</NDC11Code>
<ProductNDC>75402-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Poet Gel Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Gel Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>POET Research Center, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80982-003-39</NDCCode>
<PackageDescription>240 g in 1 TUBE (80982-003-39) </PackageDescription>
<NDC11Code>80982-0003-39</NDC11Code>
<ProductNDC>80982-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zinc Five-o</ProprietaryName>
<ProprietaryNameSuffix>Spf-50</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ASTIVITA LIMITED</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/240g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24488-003-40</NDCCode>
<PackageDescription>85.2 g in 1 CONTAINER (24488-003-40)</PackageDescription>
<NDC11Code>24488-0003-40</NDC11Code>
<ProductNDC>24488-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boy Butter</ProprietaryName>
<ProprietaryNameSuffix>Desensitizing Lubricant</ProprietaryNameSuffix>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110523</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Boy Butter Lubes</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>6.39</StrengthNumber>
<StrengthUnit>g/85.2g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps in the prevention of premature ejaculation. For temporary male genital desensitization, helping to slow the onset of ejaculation. Helps in temporarily slowing the onset of ejaculation. For reducing oversensitivity in the male in advance of intercourse.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41433-003-02</NDCCode>
<PackageDescription>2 BOTTLE in 1 BOX (41433-003-02) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41433-0003-02</NDC11Code>
<ProductNDC>41433-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Siang Pureoil Formula Ii 5ml</ProprietaryName>
<NonProprietaryName>Menthol, Peppermint, Camphor, Clove, Cinnamon Oil</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260519</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>BERTRAM (1958) COMPANY LIMITED</LabelerName>
<SubstanceName>MENTHOL; PEPPERMINT; CAMPHOR (NATURAL); CLOVE; CINNAMON OIL</SubstanceName>
<StrengthNumber>39.5; 34.5; 8; .3; .2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieve body aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73362-003-01</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (73362-003-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-003-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE</PackageDescription>
<NDC11Code>73362-0003-01</NDC11Code>
<ProductNDC>73362-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Skytrofa</ProprietaryName>
<NonProprietaryName>Lonapegsomatropin-tcgd</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761177</ApplicationNumber>
<LabelerName>Ascendis Pharma Endocrinology, Inc.</LabelerName>
<SubstanceName>LONAPEGSOMATROPIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SKYTROFA (lonapegsomatropin-tcgd) is a human growth hormone indicated for the: 1 Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)., 2 Replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD).</IndicationAndUsage>
<Description>Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using E. coli. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). In vitro assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg. SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use. After reconstitution, each prefilled cartridge delivers: 1 0.327 mL containing 0.7 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (29.8 mg) and tromethamine for pH adjustment to 5.0., 2 0.327 mL containing 1.4 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (29.1 mg) and tromethamine for pH adjustment to 5.0., 3 0.327 mL containing 1.8 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.8 mg) and tromethamine for pH adjustment to 5.0., 4 0.327 mL containing 2.1 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.4 mg) and tromethamine for pH adjustment to 5.0. , 5 0.327 mL containing 2.5 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg) trehalose dihydrate (28.1 mg) and tromethamine for pH adjustment to 5.0., 6 0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg) and tromethamine for pH adjustment to 5.0., 7 0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg) and tromethamine for pH adjustment to 5.0., 8 0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.0., 9 0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.0., 10 0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.0., 11 0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.0., 12 0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.0., 13 0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.0., 14 0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.0.</Description>
</NDC>
<NDC>
<NDCCode>84712-014-01</NDCCode>
<PackageDescription>15 g in 1 BOTTLE (84712-014-01) </PackageDescription>
<NDC11Code>84712-0014-01</NDC11Code>
<ProductNDC>84712-014</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Youbuy Teeth Whitening Powder</ProprietaryName>
<NonProprietaryName>Teeth Whitening Powder</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240913</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Guangdong Youbaijia Cosmetic Industry Co., Ltd</LabelerName>
<SubstanceName>ETHYLHEXYLGLYCERIN; SODIUM LAURYL SULFATE</SubstanceName>
<StrengthNumber>.003; .39</StrengthNumber>
<StrengthUnit>g/15g; g/15g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Contains whitening ingredients to help remove smoke stains, tea stains, coffee stains, and tartar attached to the surface of teeth,revitalizing the teeth with a bright and white color. The combination of probiotics and refreshing menthol brings a clear and comfortable feeling, while double caring for teeth, balancing the oral environment,maintaining oral health, making teeth bright and white, refreshing breath, and blooming confident smiles.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85631-003-01</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOX (85631-003-01) / 1.3 g in 1 CAPSULE</PackageDescription>
<NDC11Code>85631-0003-01</NDC11Code>
<ProductNDC>85631-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gout Relief 3310-s</ProprietaryName>
<NonProprietaryName>Celery Seed, Medicago Sativa Whole,chicory Root</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250728</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Bispit Canada Ltd.</LabelerName>
<SubstanceName>GLUCOSAMINE HYDROCHLORIDE; MORUS ALBA LEAF; LICORICE; PUERARIN; BUCKWHEAT; SODIUM CHLORIDE; MEDICAGO SATIVA WHOLE; TEA LEAF; CELERY SEED; CHICORY ROOT</SubstanceName>
<StrengthNumber>130; 39; 2.6; 65; 91; 26; 260; 65; 260; 234</StrengthNumber>
<StrengthUnit>mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g; mg/1.3g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dissolved CrystallizationKidney StoneGallstone< Urinary Calculus.</IndicationAndUsage>
</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>70661-002-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (70661-002-10) </PackageDescription>
<NDC11Code>70661-0002-10</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>20210615</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>70661-002-30</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>70661-004-10</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>70661-004-30</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>70661-005-30</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>70661-005-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70661-005-90) </PackageDescription>
<NDC11Code>70661-0005-90</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>
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<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>70661-006-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70661-006-90) </PackageDescription>
<NDC11Code>70661-0006-90</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>70661-007-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70661-007-90) </PackageDescription>
<NDC11Code>70661-0007-90</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>
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